Arn Report List 20200505

Recall Action Result Summary
You searched for recall action reports between 01/07/2012 – 03/05/2020:
© Commonwealth of Australia 2020.

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use
or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not
use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of
that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice,
all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way
(electronic or otherwise) without first being given specific written permission from the Commonwealth to do so.
Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic
Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.
System for Australian Recall Actions
Important information on the System for Australian Recall Actions

The TGA publishes information about therapeutic goods supplied in the Australian market that have been
subject to a recall action in a publicly searchable database.
Recall action means action taken by the responsible entity (being the person who is responsible for taking the
recall action) to resolve a problem with therapeutic goods supplied in the Australian market that have, or may
potentially have, deficiencies relating to safety, quality, efficacy (performance) or presentation.
• Recall actions include: the permanent removal of therapeutic goods from supply in the market, the
taking of corrective action in relation to therapeutic goods (such as repair, modification, adjustment or
relabelling) and, in the case of medical devices that have been implanted into patients, the issuing of a
hazard alert containing information for health practitioners on how to manage patients.
• More information about Australian recall actions is available at <http://tga.gov.au/safety/recalls-about.htm>
• If you are taking a medicine, using a medical device or have had a medical device implanted into you,
that is the subject to a recall action, and you have any concerns you should seek advice from a health
professional. <http://www.healthdirect.org.au/>
About the release of this information

While reasonable care is taken to ensure that the information is an accurate record of recall actions that responsible
entities have reported to the TGA or of which the TGA has become aware, the TGA does not guarantee or warrant the
accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose.
To the fullest extent permitted by law, including but not limited to section 61A of the Therapeutic Goods Act 1989, the
TGA will not be liable for any loss, damage, cost or expense incurred in or arising by reason of any person relying on
this information.
The information contained in the SARA database is released under s 61(5C) of the Therapeutic Goods Act 1989.
Copyright restrictions apply to the System of Australian Recall actions (SARA) <http://tga.gov.au/about/website-
copyright.htm>.
Report generated 5/05/2020 9:36:56 PM Page 2 of 305

Recall Action Details

Number of recall actions: 5104
Recall Action Product Name/Descriptionii Type of Recall Actioniv Recall Action Recall
Commencement Productiii Classificationv Action
Datei Levelvi
1/05/2020 Aptio Automation, FlexLab Medical Product Defect Class II Hospital
Automation & FlexLab HS Device Correction
Automation. An in vitro
diagnostic medical device (IVD).
30/04/2020 ARCHITECT iGentamicin Medical Product Defect Class II Hospital
Reagent Kit. An in vitro Device Correction
diagnostic medical device (IVD)
30/04/2020 DDU-2000 Series Automated Medical Recall Class I Consumer
External Defibrillator (AED) Device
30/04/2020 Header Bags Packaging of Medical Recall Class II Hospital
Custom Tubing Packs Device
30/04/2020 Tissue saturation oximeter Medical Product Defect Class III Hospital
Device Correction
29/04/2020 15 cm IRE Single Electrode Medical Recall Class II Hospital
RFID Activation Device
29/04/2020 ABL80 series analysers including Medical Product Defect Class II Hospital
ABL80 FLEX Full panel & ABL80 Device Correction
FLEX CO-OX Analysers. An in
vitro diagnostic medical device
(IVD)
29/04/2020 Access Sensitive Estradiol Medical Product Defect Class II Hospital
Calibrators. An in vitro diagnostic Device Correction
medical device (IVD)
29/04/2020 BeGraft Coronary Stent Graft Medical Recall Class II Hospital
System, diameter 3mm, length Device
18-24mm
29/04/2020 CARESCAPE ONE Monitor Medical Product Defect Class I Hospital
Device Correction
29/04/2020 R3 Acetabular Shells Medical Recall Class II Hospital
Device
29/04/2020 Restoration Anatomic Shell Medical Hazard Alert Class II Hospital
(RAS) sizes 54mm – 68mm, Device
(Left & Right)
29/04/2020 Syngo Dynamics Medical Product Defect Class II Hospital
Device Correction
28/04/2020 Beta-2 Microglobulin. An in vitro Medical Product Defect Class II Hospital
diagnostic medical device (IVD) Device Correction
28/04/2020 Brilliance iCT, Brilliance iCT SP Medical Product Defect Class II Hospital
system, and IQon Spectral CT Device Correction
28/04/2020 Haemodialysis Blood Cartridge Medical Product Defect Class I Hospital
Sets Device Correction
28/04/2020 Nile Alternative Fixation Spinal Medical Recall Class II Hospital
System Band Device
24/04/2020 ARTIS icono floor Medical Product Defect Class II Hospital
Device Correction

The TGA publishes Australian recall actions in a searchable database to ensure the public has access to information
about therapeutic products that have been recalled from the Australian market. If you are concerned about your health
or if you have experienced an adverse event please seek advice from a health professional as soon as possible.
Please read all the important information at the beginning of this report.
Datei Levelvi
24/04/2020 ARTIS pheno Medical Product Defect Class II Hospital
Device Correction
24/04/2020 Philips Sterilizable Defibrillator Medical Product Defect Class II Hospital
Internal Paddles Device Correction
24/04/2020 Various Polyethylene Implants Medical Hazard Alert Class I Hospital
Device
23/04/2020 Medicina ENFit NGP and Ryles Medical Product Defect Class II Hospital
Nasogastric Feeding Tubes Device Correction
23/04/2020 Philips Allura and Azurion Medical Product Defect Class II Hospital
systems Device Correction
22/04/2020 XperGuide Software in Philips Medical Product Defect Class II Hospital
Azurion 2.0 system Device Correction
21/04/2020 Access hsTnI Reagent Medical Product Defect Class II Hospital
Device Correction
20/04/2020 Coagulation Factor V Deficient Medical Recall Class II Hospital
Plasma. An in vitro diagnostic Device
20/04/2020 Jamshidi Bone Marrow Medical Recall Class II Hospital
Biopsy/Aspiration Needle Device
20/04/2020 Optilite IE700 analyser (SW Medical Product Defect Class II Hospital
V7.0/7.0.1). An in vitro diagnostic Device Correction
16/04/2020 ORTHO VISION and ORTHO Medical Product Defect Class II Hospital
VISION Max Analyser. An in vitro Device Correction
15/04/2020 AQT90 series analysers. An in Medical Product Defect Class II Hospital
vitro diagnostic medical device Device Correction
(IVD)
15/04/2020 IPS e.max ZirCAD Cerec LT A2 Medical Recall Class II Retail
& A3 C17/5 Device
15/04/2020 Siemens SOMATOM go.Now, Medical Product Defect Class II Hospital
go.Up, go.All, go.Top running Device Correction
syngo.CT VA20A
14/04/2020 Gibco Gurr Buffer Tablets. An in Medical Product Defect Class II Hospital
(IVD)
14/04/2020 Monaco Treatment Planning Medical Product Defect Class II Hospital
System 5.40 or 5.40.01 Device Correction
14/04/2020 Spectranetics Bridge Occlusion Medical Product Defect Class II Hospital
Balloon Catheter Device Correction
9/04/2020 Adrenocorticotropic Hormone Medical Product Defect Class III Hospital
(ACTH) Assay used on Device Correction
IMMULITE, IMMULITE 1000,
IMMULITE 2000, IMMULITE
2000 XPi. An in vitro diagnostic
9/04/2020 CareLink 2090 Programmer & Medical Product Defect Class II Hospital
Encore 29901 Programmer Device Correction

Datei Levelvi
8/04/2020 Therascreen EGFR RGQ PCR Medical Product Defect Class II Hospital
Kit & EGFR Plasma RGQ PCR Device Correction
Kit. An in vitro diagnostic medical
device (IVD).
7/04/2020 The FlexLab (Accelerator a3600 Medical Product Defect Class II Hospital
and Aptio Automation) modular Device Correction
systems. An in vitro diagnostic
7/04/2020 YAG/SLT Devices Medical Product Defect Class II Hospital
Device Correction
6/04/2020 Multiple Philips MRI Systems Medical Product Defect Class III Hospital
Device Correction
3/04/2020 Chest Support Medical Product Defect Class I Consumer
Device Correction
3/04/2020 Defibrotide 200mg/2.5mL vial Medicine Recall Class I Hospital
2/04/2020 ADVIA Chemistry Systems Medical Product Defect Class II Hospital
1800/2400/XPT & Atellica CH Device Correction
930 Analyser. An in vitro
2/04/2020 Afinion Analyser systems. An in Medical Product Defect Class II Retail
(IVD).
2/04/2020 Aircal Device 3m Medical Recall Class II Hospital
Device
2/04/2020 ELI 380 Electrocardiograph Medical Product Defect Class III Hospital
Device Correction
2/04/2020 iChemVELOCITY Urine Medical Product Defect Class II Hospital
Chemistry System & iQ200 Device Correction
Series Urine Microscopy
Analyser. An in vitro diagnostic
medical (IVD)
2/04/2020 VITEK 2 Systems Software Medical Product Defect Class III Hospital
Version 8.01. An in vitro Device Correction
31/03/2020 Sentinel Diagnostics Medical Product Defect Class II Hospital
Plasmaproteins Cal 3X & Device Correction
Immuno Control Set. An in vitro
31/03/2020 Sodium Fluoride (18F) Injection Medicine Product Defect Class II Hospital
Alert
30/03/2020 Langston Dual Lumen Catheter Medical Recall Class II Hospital
Device
30/03/2020 VisuMax Medical Product Defect Class III Hospital
Device Correction
27/03/2020 Epix Latis Grasper Medical Recall Class II Hospital
Device
27/03/2020 PP2279 Granada agar. An in Medical Recall Class II Hospital
vitro diagnostic medical device Device
(IVD)

Datei Levelvi
27/03/2020 T34 and T34L Ambulatory Medical Product Defect Class II Hospital
Syringe Pumps Device Correction
27/03/2020 TruVidia Wireless Camera Medical Product Defect Class III Hospital
Receiver Device Correction
25/03/2020 Philips V60 Ventilators Medical Product Defect Class I Hospital
Device Correction
24/03/2020 da Vinci Xi and da Vinci X Medical Product Defect Class II Hospital
Surgical System Device Correction
24/03/2020 HeartStart MRx Monitor / Medical Product Defect Class I Hospital
Defibrillator Device Correction
24/03/2020 Rapid Plus 1 system Medical Product Defect Class II Hospital
Device Correction
23/03/2020 LeMaitre 5F Plus Over the Wire Medical Recall Class II Hospital
Embolectomy Catheter Device
23/03/2020 Philips TRx4851A Telemetry Medical Product Defect Class I Hospital
Transceivers used with Patient Device Correction
Information Center iX C.02.xx or
C.03.01.
20/03/2020 AK 98 Hemodialysis Devices Medical Product Defect Class II Hospital
software version V3.0 Device Correction
20/03/2020 CORFLO PEG Kit Medical Recall Class II Hospital
Device
20/03/2020 Footprint Ultra PK Suture Anchor Medical Recall Class II Hospital
4.5mm & 5.5mm Device
19/03/2020 Alere NT-proBNP for Medical Recall Class II Hospital
ARCHITECT and Alinity i Device
Calibrators and Controls. An in
(IVD)
19/03/2020 Philips SensaVue Medical Product Defect Class III Hospital
Device Correction
19/03/2020 Sterile plastic bushings Medical Recall Class II Hospital
accessory Device
18/03/2020 Corpuls3 devices Medical Product Defect Class I Hospital
Device Correction
18/03/2020 Dade Ci-Trol 1. An in vitro Medical Product Defect Class II Hospital
18/03/2020 FluoroQuench. An in vitro Medical Recall Class III Hospital
diagnostic medical device (IVD) Device
17/03/2020 Microvascular Coupler Device Medical Recall Class II Hospital
2.0 mm & 2.5 mm Device
17/03/2020 Radiometer safeCLINITUBES Medical Recall Class II Hospital
Blood Samplers. An in vitro Device
16/03/2020 MICROPLAS plasmafilter Medical Recall Class I Hospital
Device
16/03/2020 MyWay Harnesses Medical Recall Class II Consumer
Device
16/03/2020 SOMATOM Force CT Scanner Medical Product Defect Class II Hospital
Device Correction

Datei Levelvi
13/03/2020 F18-FDG Injection Medicine Product Defect Class III Hospital
Correction
13/03/2020 RayStation and RayPlan Medical Product Defect Class II Hospital
Systems Device Correction
13/03/2020 Sotalol Carinopharm 40 mg / 4 Medicine Recall Class I Hospital
ml solution for injection
12/03/2020 Azurion Interventional Medical Product Defect Class II Hospital
Fluoroscopic X-ray system Device Correction
12/03/2020 Curam Duo 400/57 Powder for Medicine Product Defect Class II Retail
Oral Suspension Correction
12/03/2020 Expression MR400 MRI Patient Medical Product Defect Class II Hospital
Monitoring System Device Correction
12/03/2020 Wassenburg Dryer320 Medical Product Defect Class II Hospital
Device Correction
11/03/2020 ADVIA 120/2120/2120i CBC Medical Recall Class III Hospital
TIMEPAC and ADVIA Device
120/2120/2120i CN-Free CBC
TIMEPAC. An in vitro diagnostic
11/03/2020 NAVIO Soft Tissue Protector Medical Product Defect Class II Hospital
supplied in NAVIO Instrument Kit Device Correction
11/03/2020 Sensor Nitinol Guidewire with Medical Recall Class II Hospital
Hydrophilic Tip Device
10/03/2020 Global Cup 3-Hole Porous & HA Medical Recall Class III Hospital
Coated Size 44 & 64 Device
10/03/2020 N Latex CDT Kit. An in vitro Medical Recall Class II Hospital
10/03/2020 Radiometer ABL800 series blood Medical Product Defect Class II Hospital
gas analysers. An in vitro Device Correction
6/03/2020 R-F Cobra Injector Cannula 18g Medical Recall Class III Hospital
& 20g Device
5/03/2020 Atellica CH 930 Analyser. An in Medical Product Defect Class II Hospital
(IVD).
3/03/2020 MAGEC System - Model X Rods Medical Hazard Alert Class II Hospital
Device
3/03/2020 Siemens Ysio Fully Automated Medical Product Defect Class II Hospital
with Software Version VB10 Device Correction
2/03/2020 HiRes Ultra Cochlear Implants Medical Hazard Alert Class II Hospital
Device
2/03/2020 TEG MANAGER Software with Medical Product Defect Class II Hospital
TEG 5000 Device Correction
28/02/2020 Allergan Breast Implants Medical Hazard Alert Class II Hospital
Device
28/02/2020 JT Medical POLYTECH Breast Medical Hazard Alert Class II Hospital
Implants Device

Datei Levelvi
28/02/2020 KWIK-STIK 2 Pack Trichosporon Medical Recall Class II Hospital
dermatis derived from ATCC Device
204094. An in vitro diagnostic
28/02/2020 MENTOR SILTEX Microtextured Medical Hazard Alert Class II Hospital
and Smooth Breast Implants and Device
Tissue Expanders
28/02/2020 Motiva Sterile Silicone Breast Medical Hazard Alert Class II Hospital
Implants Device
28/02/2020 Paragel Cohesive Gel Implant Medical Hazard Alert Class II Hospital
Device
28/02/2020 Sebbin Round Breast Implants Medical Hazard Alert Class II Hospital
Microtextured (Firm High Device
Cohesive Gel Mammary
implants)
28/02/2020 Various Nagor Mammary Medical Hazard Alert Class II Hospital
Implants Device
27/02/2020 Fludeoxyglucose F18 Injection Medicine Recall Class II Hospital
(18F-FDG)
27/02/2020 Medtronic Conexus Telemetry Medical Product Defect Class II Hospital
Device Correction
27/02/2020 PP2022 Horse Blood Agar Medical Recall Class III Hospital
(HBA)/MacConkey agar split Device
plates. An in vitro diagnostic
26/02/2020 MULTIX Impact software version Medical Product Defect Class II Hospital
VA10E Device Correction
24/02/2020 AXIOM Aristos FX Plus Medical Product Defect Class II Hospital
Device Correction
20/02/2020 ARTIS zeego and Artis Medical Product Defect Class II Hospital
zee/Q/Q.zen systems with Device Correction
Siemens Healthineers Table
(Tilt/Step, OR)
19/02/2020 Atellica CH Ethyl Alcohol Medical Product Defect Class II Hospital
(ETOH). An in vitro diagnostic Device Correction
19/02/2020 BD Alaris Systems Medical Product Defect Class I Hospital
Device Correction
19/02/2020 Endocuff Vision Medical Product Defect Class II Hospital
Device Correction
19/02/2020 Factor VIII assays on Stago Medical Product Defect Class II Hospital
Instruments. An in vitro Device Correction
19/02/2020 Medtronic Covidien Force Medical Product Defect Class II Hospital
TriVerse electrosurgical devices Device Correction
within Medline Procedure Packs
19/02/2020 Pipeline Flex Embolization Medical Recall Class I Hospital
Device and Pipeline Flex Device
Embolization Device with Shield
Technology

Datei Levelvi
18/02/2020 ADVIA Chemistry Direct Bilirubin Medical Product Defect Class II Hospital
(DBIL_2) and Total Bilirubin Device Correction
(TBIL_2) Assays. An in vitro
18/02/2020 Atellica CH Direct Bilirubin Medical Product Defect Class II Hospital
(DBil_2) and Total Bilirubin Device Correction
(TBil_2) Assays. An in vitro
18/02/2020 Dimension Total Bilirubin (TBI) Medical Product Defect Class II Hospital
Flex reagent cartridge. An in vitro Device Correction
18/02/2020 Dimension Vista Total Bilirubin Medical Product Defect Class II Hospital
(TBIL) Flex reagent cartridge. An Device Correction
in vitro diagnostic medical device
(IVD).
18/02/2020 Organ Transport Container, Medical Recall Class II Hospital
Femoral Head Pack Device
18/02/2020 Site Rite 8 Ultrasound System Medical Product Defect Class II Hospital
Device Correction
18/02/2020 uE3 KRYPTOR. An in vitro Medical Product Defect Class II Hospital
diagnostic medical device (IVD). Device Correction
17/02/2020 CLINITEK Status+ Analysers Medical Product Defect Class II Hospital
and CLINITEK Status Connect Device Correction
Systems. An in vitro diagnostic
17/02/2020 Microbore Extension Sets Medical Recall Class II Hospital
Device
14/02/2020 Imager 5F II Angiographic Medical Recall Class I Hospital
Catheter Device
13/02/2020 Palamix UNO Medical Product Defect Class II Hospital
Device Correction
13/02/2020 Various Surgical Instruments Medical Recall Class II Hospital
within Surgical Sets Device
12/02/2020 PALEXIA SR 100 mg tapentadol Medicine Product Defect Class II Consumer
(as hydrochloride) sustained Correction
release tablets
12/02/2020 RAPIDLyte Arterial Line Draw Medical Recall Class II Hospital
Syringes Device
12/02/2020 Stealth Spring Clips 6mm Medical Recall Class II Hospital
Device
11/02/2020 Arista AH 3g Medical Product Defect Class III Hospital
Device Correction
11/02/2020 BiomarC Preloaded Tissue Medical Product Defect Class II Hospital
Marker Device Device Correction
11/02/2020 IMMULITE Systems Estradiol Medical Product Defect Class II Hospital
assay. An in vitro diagnostic Device Correction
11/02/2020 Peters Surgical Monopolar Medical Product Defect Class II Hospital
Instrument Device Correction

Datei Levelvi
11/02/2020 Radiometer ABL90FLEX and Medical Product Defect Class II Hospital
ABL90FLEX Plus. An in vitro Device Correction
10/02/2020 Femoral Head Allograft B Hazard Alert Class II Hospital
10/02/2020 Inogen One G3 Concentrator Medical Product Defect Class II Consumer
Device Correction
10/02/2020 Ranitidine Hydrochloride, USP Medicine Recall Class II Retail
7/02/2020 Covidien Force TriVerse Medical Recall Class II Hospital
electrosurgical device Device
7/02/2020 McGrath X3 Disposable Medical Recall Class II Hospital
Laryngoscope Blades Device
6/02/2020 Bock Nursing Care Beds - Medical Product Defect Class II Consumer
Battery Device Correction
6/02/2020 Bock Nursing Care Beds - Lifting Medical Product Defect Class II Consumer
Poles Device Correction
6/02/2020 Philips Efficia Combined Cable/3 Medical Product Defect Class I Hospital
or 5 Leadsets Device Correction
5/02/2020 Arrow FlexTip Plus Epidural Medical Recall Class I Hospital
Catheterisation Sets and Kits Device
5/02/2020 Hemospray Endoscopic Medical Recall Class I Hospital
Hemostat Device
5/02/2020 i-STAT CHEM 8+, CG4+ and Medical Product Defect Class III Hospital
G3+ Cartridges (blue). An in vitro Device Correction
5/02/2020 Taewoong Medical Niti-S Bumpy Medical Recall Class II Hospital
Biliary Covered Short Stents Device
4/02/2020 Ellipse Implantable Cardioverter Medical Product Defect Class III Hospital
Defibrillators Device Correction
4/02/2020 F18-FDG Medicine Recall Class III Hospital
4/02/2020 Rotor-Gene Q software version Medical Product Defect Class I Hospital
2.3.4. An in vitro diagnostic Device Correction
3/02/2020 ARTIS Pheno Systems Medical Product Defect Class II Hospital
Device Correction
3/02/2020 Biocartis BTA00606 Idylla EGFR Medical Product Defect Class II Hospital
Mutation Test. An in vitro Device Correction
3/02/2020 Breath-A-Tech (Standard and Medical Product Defect Class II Retail
Hospital Grade) Spacers Device Correction
3/02/2020 PSPIX Digital Imaging Plate Medical Product Defect Class II Retail
Scanner (first generation) Device Correction
31/01/2020 Alinity ci-series System Control Medical Product Defect Class II Hospital
Module (SCM). An in vitro Device Correction
31/01/2020 FeverBugz stick on Medical Product Defect Class III Consumer
Thermometer Device Correction
31/01/2020 Medtronic HeartWare HVAD Medical Product Defect Class I Hospital
System Battery Charger AC Device Correction
Adapter and Controller

Datei Levelvi
31/01/2020 Teleflex Premium Diamond Edge Medical Recall Class II Hospital
Aortic Punch Device
30/01/2020 Elecsys CA 19-9 reagent for use Medical Product Defect Class II Hospital
on the cobas e 801 analytical Device Correction
unit. An in vitro diagnostic
30/01/2020 IntelePACS – InteleViewer Medical Product Defect Class II Hospital
versions 4-17-1 and up Device Correction
30/01/2020 Mayer's Haematoxylin Stain Medical Recall Class III Hospital
(Original Formulation). An in vitro Device
29/01/2020 BioFire FilmArray Blood Culture Medical Product Defect Class II Hospital
Identification (BCID) Panel Kit. Device Correction
An in vitro diagnostic medical
device (IVD)
29/01/2020 BladderScan BVI 3000 Medical Product Defect Class III Hospital
Ultrasound System Device Correction
29/01/2020 NC Trek RX Coronary Dilatation Medical Recall Class I Hospital
Catheter 4.0mm, 4.5mm and Device
5.0mm
29/01/2020 Olympus Pleuravideoscope, Medical Product Defect Class II Hospital
LTF-160 Device Correction
29/01/2020 T34 Syringe Pump, 3rd edition Medical Product Defect Class II Hospital
Device Correction
28/01/2020 Drager Infinity Central Station; Medical Product Defect Class III Hospital
software version VG2.1.2 Device Correction
28/01/2020 UTAK Validity Control 4. An in Medical Product Defect Class III Hospital
(IVD)
24/01/2020 Technetium-99m Cardiolite Medicine Recall Class II Hospital
23/01/2020 Cardinal Health Non-Reinforced Medical Recall Class II Hospital
Surgical Gowns & Fabric- Device
Reinforced Surgical Gowns
23/01/2020 Mako MICS Irrigation Clip Medical Recall Class II Hospital
Device
22/01/2020 Atellica CH Reaction Cuvette Medical Recall Class II Hospital
Segment. An in vitro diagnostic Device
22/01/2020 Autocon III 300 and Autocon III Medical Product Defect Class III Hospital
400 High Frequency Generators Device Correction
22/01/2020 Green Rusch Lite Disposable Medical Recall Class II Hospital
Metal Laryngoscope Blade Device
21/01/2020 Liquichek Cardiac Markers Plus Medical Product Defect Class III Hospital
Control LT. An in vitro diagnostic Device Correction
21/01/2020 Neon3 Universal OCT Spinal Medical Recall Class II Hospital
Stabilisation Device
17/01/2020 Liquichek Cardiac Markers Plus Medical Product Defect Class III Hospital
Control LT. An in vitro diagnostic Device Correction

Datei Levelvi
17/01/2020 Monopolar Cable Medical Product Defect Class II Hospital
Device Correction
17/01/2020 Telescopic Smoke Evacuation Medical Recall Class II Hospital
Pencil Device
17/01/2020 Various Monopolar Instruments Medical Product Defect Class II Hospital
Device Correction
16/01/2020 Arrow PICC Set Medical Product Defect Class III Hospital
Device Correction
16/01/2020 Equinoxe Platform Fracture Medical Product Defect Class III Hospital
Humeral Stem, Cemented Device Correction
16/01/2020 IMMULITE Systems - Medical Product Defect Class II Hospital
Progesterone (PRG). An in vitro Device Correction
16/01/2020 Letco Medical Estriol USP Medicine Recall Class II Retail
16/01/2020 O-arm O2 Imaging System – Medical Product Defect Class II Hospital
Motor Drive Belt Device Correction
15/01/2020 Velara X-Ray Generator of the Medical Product Defect Class II Hospital
Philips Allura Xper, Integris, Device Correction
MultiDiagnost Eleva and
OmniDiagnost Systems
14/01/2020 NUCLISENS Lysis Buffer. An in Medical Product Defect Class I Hospital
(IVD)
13/01/2020 Maestro 4000 Cardiac Ablation Medical Product Defect Class I Hospital
System Device Correction
13/01/2020 Philips Digitrak XT Holter Monitor Medical Product Defect Class III Hospital
Device Correction
13/01/2020 Various Cios Systems Medical Product Defect Class II Hospital
Device Correction
10/01/2020 Eclipse Treatment Planning Medical Product Defect Class II Hospital
System, versions 15.5 and 15.6 Device Correction
10/01/2020 SPY-PHI Drapes Medical Recall Class II Hospital
Device
10/01/2020 TrueBeam / VitalBeam Medical Product Defect Class II Hospital
Radiotherapy System and EDGE Device Correction
RadioSurgery System
9/01/2020 LIFEPAK 15 Monitor/Defibrillator Medical Product Defect Class I Hospital
Device Correction
9/01/2020 Ysio Max, Luminos dRF Max, Medical Product Defect Class II Hospital
Luminos Agile Max and Uroskop Device Correction
Omnia Max with software
versions VE10Q and VE10U
8/01/2020 Certain BellaTek Encode Healing Medical Recall Class II Retail
Abutments Device
8/01/2020 McKesson/Horizon/Change Medical Product Defect Class II Hospital
Healthcare Cardiology Hemo Device Correction
8/01/2020 Sealer Foil Cartridge. An in vitro Medical Recall Class III Hospital

Datei Levelvi
7/01/2020 Atellica IM Humidity Pack. An in Medical Product Defect Class II Hospital
(IVD)
7/01/2020 Femcare Australia Filshie Clips, Medical Product Defect Class II Hospital
Standard Sterishot Kits and Device Correction
Minilap Sterishot Kits
7/01/2020 Gore Excluder Devices Medical Product Defect Class II Hospital
Device Correction
7/01/2020 Immuno Concepts Image Medical Product Defect Class III Hospital
Navigator software Version 3 Device Correction
and 4 (ICINUP). An in vitro
6/01/2020 ADVIA Chemistry Lipase. An in Medical Product Defect Class II Hospital
(IVD)
6/01/2020 ADVIA Chemistry Systems - Medical Product Defect Class II Hospital
Enzymatic Creatinine_2. An in Device Correction
(IVD)
6/01/2020 Atellica CH Analyser - Enzymatic Medical Product Defect Class II Hospital
Creatinine (ECre_2) Assays. An Device Correction
(IVD)
6/01/2020 Dimension Clinical Chemistry Medical Product Defect Class II Hospital
Systems Enzymatic Creatinine Device Correction
(EZCR) Assay. An in vitro
6/01/2020 Dimension Vista Systems - Medical Product Defect Class II Hospital
Enzymatic Creatinine. An in vitro Device Correction
6/01/2020 Fludeoxyglucose F18 Injection Medicine Product Defect Class III Hospital
(18F-FDG) Correction
6/01/2020 Kangaroo Enteral Feeding Kits Medical Product Defect Class II Hospital
Device Alert
6/01/2020 Single-use insufflation tubing set Medical Recall Class II Hospital
with gas and Single-use gas filter Device
with 3.20m of insufflation tube
6/01/2020 Various RayStation and RayPlan Medical Product Defect Class II Hospital
2/01/2020 Mavidon Medical - LemonPrep Medical Recall Class II Hospital
Tubes and Single Use Cups Device
24/12/2019 Dawson-Mueller Drainage Medical Recall Class II Hospital
Catheters Device
24/12/2019 RX Daytona + with ISE and RX Medical Product Defect Class III Hospital
Daytona +. An in vitro diagnostic Device Correction
23/12/2019 ‘FeNOBreath’, Factional Exhaled Medical Product Defect Class II Hospital
Nitric Oxide. An in vitro Device Correction

Datei Levelvi
23/12/2019 CAIMAN Vessel sealing Medical Recall Class II Hospital
instrument, 240 mm working Device
length, diameter 12 mm, muzzle
length: 50 mm, sterile,
disposable
23/12/2019 Cordis S.M.A.R.T. Stents Medical Product Defect Class II Hospital
Device Correction
23/12/2019 EnCor Breast Biopsy Probes Medical Product Defect Class II Hospital
Device Correction
23/12/2019 Perl's Solution B 0.64% Medical Recall Class III Hospital
Hydrochloric Acid Solution. An in Device
(IVD)
20/12/2019 Atellica IM NT-proBNP (PBNP) Medical Product Defect Class II Hospital
100 Test Kit and 500 Test Kit. An Device Correction
(IVD)
20/12/2019 DEFIGARD Touch 7 Medical Product Defect Class I Hospital
Device Correction
20/12/2019 Giraffe Blue Spot PT Lite Medical Product Defect Class II Hospital
Phototherapy Systems Device Correction
20/12/2019 Philips CombiDiagnost R90 GCF Medical Product Defect Class II Hospital
20/12/2019 Philips CombiDiagnost R90 PCF Medical Product Defect Class II Hospital
19/12/2019 F18-FDG Injection Medicine Product Defect Class III Hospital
Correction
19/12/2019 Oragene DNA. An in vitro Medical Product Defect Class II Hospital
19/12/2019 VesselNavigator application in Medical Product Defect Class II Hospital
combination with Azurion R1.2.x Device Correction
and R2.0.x
18/12/2019 All FTD CE-IVD. An in vitro Medical Recall Class II Hospital
18/12/2019 Polysorb braided monofilament Medical Recall Class II Hospital
absorbable sutures Device
18/12/2019 Tempus LS Defibrillator Medical Product Defect Class I Hospital
Device Correction
16/12/2019 Carestation 620/650/650c A1 Medical Product Defect Class II Hospital
and Carestation 620/650/650c Device Correction
A2 Anaesthesia Systems
16/12/2019 Femoral Head Allograft - Fine B Hazard Alert Class I Hospital
Milled Bone
16/12/2019 Impress Peripheral Catheter Medical Product Defect Class II Hospital
Device Correction

Datei Levelvi
16/12/2019 Liquid Clinical Chemistry Control. Medical Product Defect Class II Hospital
An in vitro diagnostic medical Device Correction
device (IVD)
13/12/2019 Philips 867036 IntelliVue MMX Medical Product Defect Class III Hospital
Multi-measurement module Device Correction
13/12/2019 Q-VAX Q FEVER VACCINE Medicine Recall Class III Retail
0.5mL injection syringe
12/12/2019 Accu-Chek Aviva test strips. An Medical Recall Class II Retail
in vitro diagnostic medical device Device
(IVD)
11/12/2019 Technetium-99m HDP Medicine Recall Class II Hospital
10/12/2019 T2 Alpha Delta Strike Plate IMN Medical Recall Class II Hospital
Instruments Device
10/12/2019 Various GE Healthcare MRI Medical Product Defect Class II Hospital
9/12/2019 Estriol USP (Micronised) Medicine Product Defect Class II Retail
Correction
6/12/2019 Cios Alpha systems Medical Product Defect Class II Hospital
Device Correction
6/12/2019 Kit Cobas 4800 Sample Prep 2 Medical Recall Class III Hospital
960T CE-IVD. An in vitro Device
5/12/2019 Ceramir Crown & Bridge Medical Recall Class III Retail
QuikCap Device
5/12/2019 GSP Neonatal IRT Kit. An in vitro Medical Product Defect Class II Hospital
5/12/2019 iMRX System Medical Product Defect Class II Hospital
Device Correction
5/12/2019 Mazor X Surgical System (SST2) Medical Product Defect Class II Hospital
– Positioner Type II Device Correction
4/12/2019 Stellar 100 and 150 Portable Medical Product Defect Class II Consumer
Ventilators Device Correction
3/12/2019 ARCHITECT Reaction Vessels. Medical Recall Class II Hospital
An in vitro diagnostic medical Device
device (IVD)
3/12/2019 Mobile Power Unit for Heartmate Medical Product Defect Class I Hospital
3 LVAS Device Correction
3/12/2019 Various SOMATOM Definition Medical Product Defect Class II Hospital
Edge, AS, Flash and DS Device Correction
systems with
syngo.CT software versions VA4
4A_SP6
2/12/2019 Bediol Medicinal Cannabis Medicine Product Defect Class III Consumer
Correction
2/12/2019 Medilogic – TM-317 Pneumodart Medical Recall Class I Hospital
Device
2/12/2019 SOMATOM go.Now, Medical Product Defect Class II Hospital
SOMATOM go.Up, SOMATOM Device Correction
go.All, SOMATOM go.Top with
syngo.CT software versions
VA20A (all released versions)

Datei Levelvi
29/11/2019 Brauer Teething Gel 20g tube Medicine Recall Class I Consumer
29/11/2019 Radiometer ABL90 FLEX and Medical Product Defect Class II Hospital
ABL90 FLEX Plus blood gas Device Correction
analysers. An in vitro diagnostic
28/11/2019 3M Durapore Advanced Surgical Medical Recall Class I Hospital
Tape Device
28/11/2019 EIT Cellular Titanium Cervical Medical Product Defect Class III Hospital
Cages and EIT Cellular Titanium Device Correction
Lumbar Cages
28/11/2019 F18-FDG Medicine Product Defect Class II Hospital
Correction
28/11/2019 Xper Information Management Medical Product Defect Class II Hospital
System version 2.4.2 and 2.4.3 Device Correction
27/11/2019 ADVIA Chemistry Systems - Medical Product Defect Class III Hospital
CardioPhase High Sensitivity C- Device Correction
Reactive Protein (hsCRP)
Calibrator. An in vitro diagnostic
27/11/2019 Atellica CH 930 Analyser - High Medical Product Defect Class III Hospital
Sensitivity C-Reactive Protein Device Correction
(hsCRP) Calibrator. An in vitro
27/11/2019 Xpert HIV-1 Viral Load assay. An Medical Product Defect Class II Hospital
in vitro diagnostic medical device Device Correction
(IVD)
26/11/2019 ARJO 'All Day' Slings Medical Product Defect Class II Hospital
Device Correction
26/11/2019 CONMED Linvatec Medical Recall Class II Hospital
Electrosurgical Tip Cleaner Device
25/11/2019 CV-11 component of UN3000 Medical Product Defect Class II Hospital
Fully Automated Integrated Urine Device Correction
Analyser. An in vitro diagnostic
22/11/2019 Adagio. An in vitro diagnostic Medical Product Defect Class II Hospital
medical device (IVD) Device Correction
22/11/2019 Eleganza 5 Beds Medical Product Defect Class II Hospital
Device Correction
22/11/2019 Flexitron HDR/PDR and Flexitron Medical Product Defect Class II Hospital
Co-60 systems Device Correction
22/11/2019 HABIB EUS RFA Medical Recall Class II Hospital
Device
22/11/2019 HALYARD Closed Suction Medical Product Defect Class I Hospital
System for Neonates / Device Correction
Paediatrics (5 Fr)
22/11/2019 Monaco Treatment Planning Medical Product Defect Class I Hospital
System version 5.40 and above Device Correction
22/11/2019 USS II Polyaxial 3D Head Medical Hazard Alert Class I Hospital
Device
21/11/2019 Azurion Interventional Medical Product Defect Class III Hospital
Fluoroscopic X-Ray Systems Device Correction

Datei Levelvi
21/11/2019 Multiple RayStation / RayPlan Medical Product Defect Class II Hospital
21/11/2019 Python Catheters, BARD Latex- Medical Recall Class II Hospital
free Arterial Embolectomy Device
Catheters, and Over-the-Wire
latis Graft Cleaning Catheters
21/11/2019 SOMATOM Force with software Medical Product Defect Class II Hospital
syngo.CT VA50A, SOMATOM Device Correction
Drive and SOMATOM
Confidence with software
syngo.CT VA62A
19/11/2019 STAGO STA Unicalibrator. An in Medical Product Defect Class II Hospital
(IVD)
18/11/2019 Passive Biopsy Needle Kits Medical Recall Class II Hospital
Device
15/11/2019 EliA ANA Positive Control Medical Recall Class III Hospital
2500/5000. An in vitro diagnostic Device
15/11/2019 TOMTEC – ARENA version Medical Product Defect Class II Hospital
software 2.20 and lower Device Correction
14/11/2019 Femoral Head Allograft Biological Hazard Alert Class II Hospital
14/11/2019 Free Gliding SCFE Screw Medical Recall Class II Hospital
System Device
14/11/2019 Philips Incisive CT Systems Medical Product Defect Class III Hospital
Device Correction
13/11/2019 AQT90 Cleaning Solution Tubes. Medical Recall Class II Hospital
device (IVD)
13/11/2019 ARCHITECT CRP Vario and Medical Product Defect Class II Hospital
Alinity c CRP Vario Reagent Kits. Device Correction
device (IVD)
13/11/2019 Colour Cuff Disposable Medical Recall Class II Hospital
Tourniquet Cuffs Device
12/11/2019 Aequalis Ascend Flex Stem Medical Product Defect Class II Hospital
Implants Device Correction
12/11/2019 Friendly & H-Max C Cemented Medical Hazard Alert Class II Hospital
Femoral Stems Device
12/11/2019 LIGAMAX – 5mm Endoscopic Medical Recall Class II Hospital
Multiple Clip Applier Device
8/11/2019 Dual-Tab Electrodes Medical Recall Class II Hospital
Device
8/11/2019 EZ Glide Aortic Cannula Medical Recall Class I Hospital
Device
8/11/2019 HMTS 142D Plasma Sterilisers Medical Product Defect Class II Hospital
Device Correction
8/11/2019 STAR Total Ankle Replacements Medical Hazard Alert Class II Hospital
Device
8/11/2019 Thromborel S assay. An in vitro Medical Recall Class III Hospital

Datei Levelvi
7/11/2019 Anaesthetic Circuit Medical Product Defect Class II Hospital
Device Correction
Chemistry System. An in vitro Device Correction
7/11/2019 Oxylog 3000 Transport Medical Product Defect Class II Hospital
Ventilators Device Correction
7/11/2019 Unity Knee Cutting Block Medical Recall Class III Hospital
Device
6/11/2019 Accu-Chek blood glucose Medical Product Defect Class II Consumer
meters. An in vitro diagnostic Device Correction
6/11/2019 iQ200 Series Urine Microscopy Medical Product Defect Class II Hospital
Analyser and iChemVELOCITY Device Correction
Urine Chemistry System. An in
(IVD)
4/11/2019 HeartStart XL+ Medical Product Defect Class I Hospital
Defibrillator/Monitors Device Correction
manufactured prior to 1 May
2017
4/11/2019 MAVIDON LemonPrep 4oz Medical Recall Class II Hospital
(114g) Tubes in Diagnosys Device
Espion Ophthalmic
Electrophysiology Systems
4/11/2019 Philips HeartStart XL+ Medical Product Defect Class I Hospital
Defibrillator/Monitor Device Correction
4/11/2019 XEN 45 Glaucoma Treatment Medical Hazard Alert Class I Hospital
System - Glaucoma Shunt Device
1/11/2019 Atellica IM Testosterone II 100 Medical Product Defect Class II Hospital
and 500 Test Kits. An in vitro Device Correction
1/11/2019 Elecsys Troponin T hs for use on Medical Product Defect Class II Hospital
the cobas e 801 analytical unit. Device Correction
device (IVD)
1/11/2019 Genius 2 and Genius 3 Medical Product Defect Class II Hospital
Tympanic Thermometers Device Correction
1/11/2019 QUADROX-iD Paediatric with Medical Recall Class I Hospital
BIOLINE Coating Device
31/10/2019 3mensio Workstation (Vascular Medical Product Defect Class III Wholesale
and Structural Heart module) Device Correction
31/10/2019 Emerge Monorail PTCA Dilation Medical Recall Class II Hospital
Catheters & NC Emerge Device
Monorail PTCA Dilation
Catheters
31/10/2019 Guedel Airways Medical Recall Class II Hospital
Device
31/10/2019 Skin Prep Pads Medical Recall Class II Hospital
Device
30/10/2019 Alinity m System. An in vitro Medical Product Defect Class II Hospital

Datei Levelvi
30/10/2019 LimiTorr Volume Limiting Medical Recall Class II Hospital
External CSF Drainage and Device
Monitoring Systems
30/10/2019 Single Use Macintosh 3 Medical Recall Class II Hospital
Laryngoscope Blades Device
30/10/2019 Syramed µSP6000 Syringe Medical Product Defect Class II Retail
Drivers and Volumed µVP7000 Device Correction
Large Volume Infusion pumps
30/10/2019 Various Chemotherapy Medicine Recall Class II Hospital
Compounded Drugs
29/10/2019 Caruso’s Super Collagen Builder Medicine Recall Class III Retail
29/10/2019 Dako Autostainer Syringe Tray. Medical Product Defect Class II Hospital
device (IVD)
29/10/2019 Disposable Pressure Transducer Medical Recall Class II Hospital
System Device
29/10/2019 Haemonetics 125ml and 225ml Medical Product Defect Class II Hospital
Centrifuge Bowl Device Correction
29/10/2019 Mitomycin 2 mg Injection (pack Medicine Recall Class II Hospital
of 10 vials)
28/10/2019 Alinity c Carbon Dioxide Reagent Medical Recall Class II Hospital
Kit. An in vitro diagnostic medical Device
device (IVD)
28/10/2019 Arrow MAC Two-Lumen Central Medical Product Defect Class III Hospital
Venous Access Kit Device Alert
28/10/2019 BACT/ALERT VIRTUO A & B Medical Product Defect Class II Hospital
Units. An in vitro diagnostic Device Correction
25/10/2019 Artiset Blood Tubing System Medical Recall Class II Hospital
Device
25/10/2019 Eurosilicone Implants Medical Hazard Alert Class I Hospital
Device
25/10/2019 Sublime Line, Microthane & Medical Hazard Alert Class I Hospital
4Two Line, Single Lumen, Micro Device
Polyurethane, Silicone gel filled
Mammary Implants
25/10/2019 Textured Nagor GFX, CoGel and Medical Hazard Alert Class I Hospital
Impleo Mammary Implants Device
24/10/2019 CUSA Clarity Operator’s Manual Medical Product Defect Class II Hospital
associated with CUSA Clarity Device Correction
Console
24/10/2019 F18-FDG Medicine Product Defect Class III Hospital
Correction
24/10/2019 Max-Core Disposable Core Medical Recall Class II Hospital
Biopsy Instruments Device
24/10/2019 ORTHO BioVue System Medical Product Defect Class II Hospital
Cassettes. An in vitro diagnostic Device Correction
24/10/2019 PP2039 Anaerobic agar plates. Medical Recall Class III Hospital
device (IVD)

Datei Levelvi
24/10/2019 Tandem t:slim X2 Insulin Pump - Medical Product Defect Class II Consumer
A/C Power Adapter Device Correction
23/10/2019 Amico Go-Lift Carry Bars Medical Product Defect Class II Hospital
Device Correction
23/10/2019 Ellipse Heavy Duty Bariatric Medical Product Defect Class II Consumer
Rollator Device Correction
23/10/2019 Magic Mobility - Power Medical Product Defect Class II Consumer
Wheelchair Device Correction
23/10/2019 Radiometer ABL800 analysers Medical Product Defect Class II Hospital
measuring cRea (ABL827, Device Correction
ABL837). An in vitro diagnostic
23/10/2019 Sharesource Adequest Medical Product Defect Class II Hospital
Device Correction
23/10/2019 SynchroMed II Implantable Medical Hazard Alert Class I Hospital
Infusion Pumps Device
22/10/2019 Advanix Pancreatic Stent Medical Recall Class II Hospital
Device
22/10/2019 Atellica Solution - Atellica IM Medical Product Defect Class II Hospital
Active-B12. An in vitro diagnostic Device Correction
22/10/2019 InTouch Critical Care Bed Medical Product Defect Class II Hospital
Device Correction
22/10/2019 Torcon NB Advantage Medical Recall Class II Hospital
Angiographic Catheter Device
22/10/2019 VIDAS 3 (software versions 1.2 Medical Product Defect Class I Hospital
and higher). An in vitro Device Correction
21/10/2019 AeroForm Tissue Expander Medical Hazard Alert Class I Hospital
System Device
21/10/2019 Amico GoLift Carry Bar Medical Product Defect Class II Consumer
Device Correction
21/10/2019 Giraffe Incubator, Giraffe Medical Product Defect Class II Hospital
OmniBed, Giraffe Incubator Device Correction
Carestation, and Giraffe
OmniBed Carestation
18/10/2019 Mobile X-ray System FDR-Go Medical Product Defect Class II Hospital
Plus Device Correction
18/10/2019 VENTANA HE 600 system. An in Medical Product Defect Class II Hospital
(IVD)
17/10/2019 Akron Tilt Table Medical Product Defect Class II Hospital
Device Correction
17/10/2019 Arrow EZ-IO Intraosseous Medical Product Defect Class II Hospital
Vascular Access Needle Sets Device Correction

Datei Levelvi
17/10/2019 Medicina Oral Tip and ENFit Medical Recall Class II Retail
Home Use Low Dose Syringes Device
17/10/2019 Patient Data Manager Medical Product Defect Class II Hospital
Device Correction
17/10/2019 Roche CARDIAC Pipette 150 µL Medical Product Defect Class II Hospital
cobas h 232 POC system. An in Device Correction
(IVD)
17/10/2019 Surface Temperature Probe Medical Recall Class II Hospital
Device
17/10/2019 WECK Auto Endo5 Automatic Medical Recall Class II Hospital
Hem-o-lok Clip Appliers Device
16/10/2019 RadiForce RX360 and GX560 Medical Product Defect Class II Hospital
Monitors Device Correction
15/10/2019 Ausran (150mg and 300mg Medicine Recall Class II Retail
tablets), Chemists’ Own
Ranitidine and Chemists’ Own
Ranitidine Forte
15/10/2019 Embryology Heated Plate within Medical Product Defect Class II Hospital
the RI Witness Device Correction
15/10/2019 GSS67H Steriliser (software Medical Product Defect Class II Hospital
version earlier than 2.0.1) Device Correction
15/10/2019 UniCel DxH Slidemaker Stainer Medical Product Defect Class II Hospital
(DxH SMS) & UniCel DxH Device Correction
Slidemaker Stainer II (DxH SMS
II). An in vitro diagnostic medical
device (IVD)
14/10/2019 Panther Fusion Extraction Medical Recall Class II Hospital
Reagent-S. An in vitro diagnostic Device
14/10/2019 SOMATOM go.Top with software Medical Product Defect Class II Hospital
syngo CT VA20A_SP2 and with Device Correction
active "Guide&GO" license
11/10/2019 BACT/ALERT VIRTUO system A Medical Product Defect Class III Hospital
& B units. An in vitro diagnostic Device Correction
11/10/2019 Various SOMATOM Systems Medical Product Defect Class II Hospital
with software syngo CT VB20 or Device Correction
syngo CT VB10
11/10/2019 VeriSeq NIPT Sample Prep Kits. Medical Product Defect Class III Hospital
device (IVD)
10/10/2019 HandyVac Medical Recall Class II Hospital
Device
10/10/2019 Various Soul Pattinson Medicine Recall Class II Retail
Manufacturing (SPM) Ranitidine
Tablets
10/10/2019 Xpert Xpress Flu/RSV Assay. An Medical Recall Class II Hospital
(IVD)
9/10/2019 Epidural Positioning Device Medical Product Defect Class II Hospital
(EPD) Device Correction

Datei Levelvi
9/10/2019 Monaco version 5.40, 5.50 or Medical Product Defect Class I Hospital
5.51 Device Correction
8/10/2019 Cautery Tip Cleaner Medical Product Defect Class II Hospital
Device Correction
8/10/2019 Homocysteine. An in vitro Medical Recall Class II Hospital
8/10/2019 Systems Manager software Medical Product Defect Class I Hospital
version 12.0.1 with PCU versions Device Correction
9.X.
4/10/2019 Liquid Cardiac Control. An in Medical Product Defect Class II Hospital
(IVD)
4/10/2019 Philips V60 and V80 Ventilators Medical Product Defect Class II Hospital
Device Correction
4/10/2019 Prismaflex Control Units with Medical Product Defect Class I Hospital
software versions 7.20 and Device Correction
below
4/10/2019 TJF / JF Duodenoscope Medical Product Defect Class II Hospital
Device Correction
3/10/2019 AERO-AL Revision Housing Medical Product Defect Class II Hospital
Device Correction
3/10/2019 CARESCAPE Respiratory Medical Recall Class I Hospital
Modules Device
3/10/2019 Coles & Medix Heartburn & Acid Medicine Recall Class II Retail
Indigestion ranitidine (as
hydrochloride) tablets 14s pack
3/10/2019 Spacelabs Healthcare Inc. Xhibit Medical Product Defect Class II Hospital
Central Device Correction
2/10/2019 Cipla Ranitidine Tablets Medicine Recall Class II Retail
2/10/2019 Generic Health Ranitidine Medicine Recall Class II Retail
Tablets
2/10/2019 Symbion Ranitidine Tablets Medicine Recall Class II Retail
Chemistry Strips. An in vitro Device Correction
1/10/2019 Intellijoint HIP System - (Apple Medical Product Defect Class II Hospital
MacBook) Device Correction
1/10/2019 Ranitidine 150mg and 300mg Medicine Recall Class II Retail
(Rani 2)
1/10/2019 TherMax, Blood Warmer Unit, Medical Product Defect Class II Hospital
ROW Device Correction
1/10/2019 ZANTAC Ranitidine Medicine Recall Class II Retail
30/09/2019 Apotex Ranitidine Tablets Medicine Recall Class II Retail
30/09/2019 Cornea Biological Hazard Alert Class II Hospital
30/09/2019 Forte Family Gamma Cameras Medical Product Defect Class I Hospital
Device Correction
30/09/2019 Steam Steriliser - HS5510 EC1 Medical Product Defect Class III Hospital
Device Correction

Datei Levelvi
27/09/2019 Aquilex Fluid Control System Medical Product Defect Class II Hospital
(AQL-100CBS) Device Correction
26/09/2019 Caesarea Medical Electronics Medical Product Defect Class II Hospital
T34 Syringe Pumps Device Correction
26/09/2019 DTX Safedraw Kits and Medical Recall Class II Hospital
Meritrans DTXPlus Devices Device
26/09/2019 Exactamix Empty EVA Bags Medical Recall Class I Hospital
Device
26/09/2019 F18-FDG Medicine Recall Class II Hospital
26/09/2019 IACS and Stand Alone M540 Medical Product Defect Class II Hospital
Monitor, s/w version VG4.1.1 & Device Correction
VG4.0.3 and lower
25/09/2019 Alinity ci Level Sensor & Medical Product Defect Class II Hospital
Accessory Kits. An in vitro Device Correction
25/09/2019 Atellica CH 930 Analyser – Medical Product Defect Class II Hospital
Software versions 1.20.0 and Device Correction
below. An in vitro diagnostic
25/09/2019 FoodPrint Software V7.5 Medical Product Defect Class III Hospital
provided with CNS301-16/4 and Device Correction
CNS301-4/4 FoodPrint
Microarray 200+ Food IgG. An in
(IVD)
25/09/2019 GA 5003, Anti-Gangliosid Dot. Medical Recall Class I Hospital
device (IVD)
25/09/2019 Non-Esterified Fatty Acids Medical Recall Class II Hospital
(NEFA). An in vitro diagnostic Device
24/09/2019 Medisoft FeNO+ Medical Product Defect Class II Hospital
Device Correction
23/09/2019 AIR LIQUIDE Medical Carbon Medicine Recall Class III Hospital
Dioxide - 16.5m3 G sized
cylinder
23/09/2019 ATOK Shoulder Anchor Medical Hazard Alert Class II Hospital
Device
23/09/2019 InterVapor System Medical Product Defect Class I Hospital
Device Correction
23/09/2019 LBgard Blood Collection Tubes Medical Product Defect Class II Hospital
Device Correction
20/09/2019 DCFPyL Medicine Recall Class III Hospital
20/09/2019 Philips HeartStart FRx and HS1 Medical Recall Class I Hospital
OnSite Automated External Device
Defibrillators (AEDs)
20/09/2019 ROSA Brain 3.0 Medical Product Defect Class I Hospital
Device Correction
19/09/2019 Selected Behind-the-Ear hearing Medical Recall Class I Consumer
aids Device

Datei Levelvi
18/09/2019 Alinity hq Analyser and Alinity hs Medical Product Defect Class II Hospital
Slide Maker Stainer Module. An Device Correction
(IVD)
18/09/2019 DC-Screening II. An in vitro Medical Recall Class II Hospital
18/09/2019 Radiometer AQURE Data Medical Product Defect Class III Hospital
Management System Device Correction
17/09/2019 Sandoz Ranitidine Medicine Recall Class II Retail
17/09/2019 VHK and VKMO Adult/Small Medical Recall Class I Hospital
Adult Device
17/09/2019 VHK and VKMO(D) Adult/Small Medical Recall Class I Hospital
Adult Accessories Device
16/09/2019 Atellica UAS 800 Analyser and Medical Product Defect Class III Hospital
Atellica 1500 Automated Device Correction
Urinalysis System. An in vitro
16/09/2019 Codan US Corporation Swan- Medical Recall Class II Retail
Lock Needle-Free Connector Device
16/09/2019 GentleCool Pro Cryogen Medical Recall Class II Retail
Canister Device
16/09/2019 OriGen Products TissueVault O- Medical Product Defect Class I Hospital
Wrap and accessories Device Correction
16/09/2019 Shuttle Discovery with 4 Wheel Medical Product Defect Class II Consumer
Verve Stroller Device Correction
13/09/2019 CereLink ICP Monitor Medical Recall Class II Hospital
Device
12/09/2019 Alpha Conducting Solution used Medical Recall Class II Consumer
with Alpha-Stim M & AID devices Device
12/09/2019 Seca Baby Scale Medical Product Defect Class I Hospital
Device Correction
12/09/2019 Serres Suction Bag Liner Medical Product Defect Class II Hospital
Device Correction
11/09/2019 ILED 7 Surgical Light Systems Medical Product Defect Class III Hospital
Device Correction
11/09/2019 IMMAGE Total Immunoglobulin Medical Product Defect Class II Hospital
E (IgE) Reagent. An in vitro Device Correction
11/09/2019 STRATAFIX Spiral Uni PDS Plus Medical Recall Class III Hospital
Device
11/09/2019 SYNCHRON Systems Medical Product Defect Class II Hospital
Cannabinoid 100 ng (THC) & Device Correction
SYNCHRON Systems
Cannabinoid 50 ng (THC5)
Reagents. An in vitro diagnostic

Datei Levelvi
11/09/2019 SYNCHRON Systems Opiate Medical Product Defect Class II Hospital
300 ng (OP) Reagent and Device Correction
SYNCHRON Systems Opiate
2000 ng (OP2) Reagent. An in
(IVD)
10/09/2019 Introcan Safety IV Catheter Medical Recall Class II Hospital
Device
10/09/2019 SPROTTE Lumbar with Medical Recall Class II Hospital
Introducer Device
9/09/2019 Achilles Express and Achilles Medical Product Defect Class II Hospital
Insight System Power Cords Device Correction
9/09/2019 Dario Blood Glucose Tracker Medical Product Defect Class II Consumer
app. An in vitro diagnostic Device Correction
medical device (IVD).
9/09/2019 Multiple ApexPro Telemetry Medical Product Defect Class I Hospital
server hardware platforms Device Correction
9/09/2019 Philips S7-3t & S8-3t Medical Product Defect Class II Hospital
Transesophageal (TEE) Device Correction
Transducers
9/09/2019 Thermo Scientific Remel Medical Recall Class II Hospital
Salmonella paratyphi B-H phase Device
1 Flagellar antigen b Stained
Suspension. An in vitro
9/09/2019 Various Convex Two-Piece Skin Medical Product Defect Class II Consumer
Barriers Device Correction
6/09/2019 Prima Supervac Fingerswitch Medical Product Defect Class II Hospital
Pencils with Smoke Evacuation Device Correction
Tubing
6/09/2019 Triathlon Orthopaedic Devices Medical Hazard Alert Class II Hospital
Device
5/09/2019 Arterial Catheter Mini Kit 20ga x Medical Recall Class II Hospital
6” Device
5/09/2019 Arthrem Joint Support Capsules Medicine Recall Class II Retail
5/09/2019 C3 CryoProbe 2.1mm sharp Medical Recall Class II Hospital
Device
5/09/2019 REMISOL Advance. An in vitro Medical Product Defect Class II Hospital
4/09/2019 Atomizer – EZ Spray Medical Recall Class I Hospital
Device
4/09/2019 COBAS AmpliPrep/COBAS Medical Product Defect Class II Hospital
TaqMan HCV Quantitative Test, Device Correction
v2.0. An in vitro diagnostic
4/09/2019 Philips Efficia Medical Product Defect Class I Hospital
Defibrillator/Monitor (DFM100) Device Correction
4/09/2019 Tina-quant Soluble Transferrin Medical Product Defect Class II Hospital
Receptor. An in vitro diagnostic Device Correction

Datei Levelvi
4/09/2019 Various Assays. An in vitro Medical Product Defect Class II Hospital
3/09/2019 BM MX117 FIDIS Connective Medical Recall Class III Hospital
Profile Kit. An in vitro diagnostic Device
3/09/2019 GlideScope Core Systems Medical Product Defect Class III Hospital
Device Correction
3/09/2019 LemonPrep 114gm tubes Medical Recall Class II Hospital
Device
3/09/2019 Vanguard XP-CR Tibial Tray Medical Hazard Alert Class II Hospital
Device
2/09/2019 Euphora Semi-Compliant Rapid Medical Recall Class II Hospital
Exchange Balloon Dilatation Device
Catheters
30/08/2019 IH-1000. An in vitro diagnostic Medical Product Defect Class II Hospital
medical device (IVD). Device Correction
30/08/2019 JIN GUI SHEN QI WAN Medicine Recall Class I Consumer
30/08/2019 Rocket FBS Amnioscopes Medical Product Defect Class II Hospital
Device Correction
30/08/2019 SEM Scanner Medical Recall Class III Wholesale
Device
28/08/2019 Nutrabolics Blackout Medicine Recall Class II Retail
27/08/2019 Triathlon Femoral Distal Medical Recall Class II Hospital
Augments (10 and 15 mm, Size Device
2, Left and Right)
26/08/2019 18F-Flurodeoxy Glucose (18F- Medicine Recall Class I Hospital
FDG) for injection
26/08/2019 Atellica UAS 800 Analyser and Medical Product Defect Class II Hospital
Atellica 1500 Automated Device Correction
Urinalysis System. An in vitro
23/08/2019 BIS Vista Monitoring Systems Medical Product Defect Class II Hospital
Phase II Device Correction
23/08/2019 Medisorb Cannister 0.8kg Medical Recall Class II Hospital
Device
23/08/2019 Multiple Gold Cup Electrodes Medical Recall Class II Hospital
and Snap Electrode Leads Device
23/08/2019 TheraBead Compress Cervical Medical Product Defect Class II Retail
and TheraBead Compress STD Device Correction
21/08/2019 BD FACSLyric Flow Cytometer Medical Product Defect Class II Hospital
Device Correction
21/08/2019 Concerto Shower Trolley and Medical Product Defect Class II Retail
Basic Shower Trolley Device Correction
21/08/2019 Metafix stem size 4 Medical Recall Class II Hospital
Device

Datei Levelvi
21/08/2019 Rocket KCH Foetal Bladder Medical Product Defect Class II Hospital
Drain Device Correction
21/08/2019 VaccZyme Human Anti- Medical Recall Class II Hospital
Haemophilus lnfluenzae type b Device
Enzyme Immunoassay Kit. An in
(IVD)
20/08/2019 Atellica IM 1300 Analyser & Medical Product Defect Class II Hospital
Atellica IM 1600 Analyser with Device Correction
Software V 1.19.0 and 1.19.2. An
(IVD)
19/08/2019 ONLINE TDM Vancomycin Gen. Medical Product Defect Class II Hospital
3. An in vitro diagnostic medical Device Correction
device (IVD)
(IVD)
Benzodiazepine (BNZG) Device Correction
Reagent. An in vitro diagnostic
16/08/2019 Weinmann Adult MEDUCORE Medical Recall Class I Retail
Multifunctional Electrodes Device
15/08/2019 Economy Anaesthetic Face Medical Product Defect Class II Hospital
Mask, 22F Device Correction
(IVD)
12/08/2019 Modulus, Modulus-R and Medical Product Defect Class II Hospital
Revision modular femoral stems Device Correction
12/08/2019 Oxoid Mice STRIP MA0121 – Medical Recall Class II Hospital
Meropenem32. An in vitro Device
8/08/2019 AssayTip/AssayCup Tray. An in Medical Recall Class II Hospital
(IVD)
8/08/2019 DM DESLV5228 Demeditec Medical Recall Class II Hospital
Estrone free in saliva ELISA. An Device
(IVD)
8/08/2019 Heater Unit HU 35, 230 V Medical Product Defect Class I Hospital
Device Correction
8/08/2019 IBL RE52681, Estrone Saliva Medical Recall Class II Hospital
ELISA. An in vitro diagnostic Device
8/08/2019 Medtronic Micra Delivery System Medical Product Defect Class II Hospital
Packaged as part of Micra Device Correction
Transcatheter Pacing System
8/08/2019 Multiple da Vinci Xi and da Vinci Medical Product Defect Class II Hospital
X Systems Device Correction
8/08/2019 Quantel Medical – Easyret Laser Medical Product Defect Class II Hospital
Device Correction

Datei Levelvi
7/08/2019 Artis zee and Artis Q patient Medical Product Defect Class II Hospital
table within a specific production Device Correction
lot
7/08/2019 CVC Procedure Packs Medical Recall Class II Hospital
Device
7/08/2019 Various Haemodynamic Medical Recall Class II Hospital
Monitoring Kits Device
6/08/2019 Ad-Tech Product Catalogue Medical Product Defect Class II Hospital
Device Correction
6/08/2019 Hollister Urostomy bag Medical Recall Class III Consumer
Device
6/08/2019 Magic mobility wheelchair - Medical Recall Class II Consumer
Mobility Handles Device
6/08/2019 Steelco Endoscope Dryers Medical Product Defect Class II Hospital
Device Correction
5/08/2019 Alginate Basis Cinnamon 25lbs Medical Recall Class II Retail
and 6lbs Device
5/08/2019 PrisMax, V2, ROW Medical Product Defect Class II Hospital
Device Correction
2/08/2019 SOMATOM go.Up, SOMATOM Medical Product Defect Class II Hospital
go.All, SOMATOM go.Now and Device Correction
SOMATOM go.Top with injector
and optional storage box
2/08/2019 Swivel Elbow Connectors Medical Recall Class I Hospital
Device
31/07/2019 DP3 pump head Medical Product Defect Class I Hospital
Device Correction
31/07/2019 EXTEM Reagent. An in vitro Medical Recall Class II Hospital
30/07/2019 ADVIA Centaur, ADVIA Centaur Medical Product Defect Class II Hospital
XP, ADVIA Centaur XPT - Folate Device Correction
Assay. An in vitro diagnostic
30/07/2019 EZTest H202 Biological Medical Recall Class II Hospital
Indicators Device
30/07/2019 Floor Stands: FS 2-21, FS 2-25 Medical Product Defect Class II Hospital
and FS 3-45 with Hi-R NEO Device Correction
900/A/A NIR
30/07/2019 Macro Textured Breast Implants Medical Hazard Alert Class I Hospital
& Tissue Expanders Device
30/07/2019 MAMMOMAT Revelation VC10 Medical Product Defect Class II Hospital
with Biopsy Option Device Correction
30/07/2019 Norm-O-Temp Hyperthermia Medical Product Defect Class II Hospital
System, MICRO-TEMP LT Device Correction
System, Blanketrol II Hyper-
Hypothermia System, Blanketrol
III Hyper-Hypothermia System
and CoolBlue Hyper-
Hypothermia System

Datei Levelvi
29/07/2019 ENDONE oxycodone Medicine Product Defect Class I Consumer
hydrochloride 5mg tablet blister Correction
pack
29/07/2019 F18-FDG Injection Medicine Product Defect Class II Hospital
Alert
29/07/2019 ICS CHARTR EP 200 Medical Product Defect Class II Hospital
Device Correction
29/07/2019 KaVo RONDOflex Powder 27µm Medical Recall Class II Retail
1000g to be used with the KaVo Device
RONDOFLEX plus 360 air
abrasion system
26/07/2019 Coombs-Control IgG 1 x 10mL. Medical Product Defect Class III Hospital
device (IVD)
25/07/2019 Biograph mCT and mCT Flow Medical Product Defect Class II Hospital
systems running PETsyngo Device Correction
VG70A
25/07/2019 Impix-L Lumbar Spinal Fusion Medical Recall Class II Hospital
Cages Device
25/07/2019 SOMATOM Definition Edge , Medical Product Defect Class II Hospital
SOMATOM Definition AS, Device Correction
SOMATOM Definition Flash, with
syngo.CT software versions
VA48A_SP5
24/07/2019 KARL STORZ C-Mac Video Medical Product Defect Class II Hospital
Laryngoscope Blades Device Correction
24/07/2019 Nasal Alar SpO2 Sensor Medical Product Defect Class II Hospital
Device Correction
24/07/2019 Spectra Optia Apheresis System Medical Product Defect Class II Hospital
Device Correction
23/07/2019 Dimension clinical chemistry Medical Recall Class III Hospital
system, Ferritin (FERR) Flex Device
Reagent Cartridge. An in vitro
23/07/2019 Elecsys Anti-CCP Assay. An in Medical Product Defect Class II Hospital
(IVD)
23/07/2019 Ingenuity CT, IQon Spectral CT, Medical Product Defect Class I Hospital
iCT, Brilliance 64 CT, Ingenuity Device Correction
TF
23/07/2019 Ortho Vision and Ortho Vision Medical Product Defect Class I Hospital
Max Analyser, software versions Device Correction
5.12.3 and 5.12.4. An in vitro
23/07/2019 Transwarmer Warming Infant Medical Product Defect Class II Hospital
Transport Mattress Device Correction
22/07/2019 DAC Premium and DAC Medical Product Defect Class III Retail
Premium+ (Autoclaves) Device Correction
22/07/2019 F18-FDG Injection Medicine Product Defect Class II Hospital
(Fludeoxyglucose F18) Correction
22/07/2019 iGUIDE 2.2.0 - 2.2.2 Medical Product Defect Class II Hospital
Device Correction

Datei Levelvi
22/07/2019 MAJ-1664 - Nurses Control Medical Product Defect Class II Hospital
Panel Arm-Long Device Correction
22/07/2019 Omegapharm Thiopental Sodium Medicine Product Defect Class III Hospital
Powder for Injection Alert
22/07/2019 Panetti ENT endoscopic ear Medical Product Defect Class II Hospital
instruments Device Correction
22/07/2019 Radiometer ABL90FLEX blood Medical Product Defect Class II Hospital
gas analyser and Radiometer Device Correction
AQT90FLEX immunoassay
analyser. An in vitro diagnostic
19/07/2019 Da Vinci Xi SureForm 60 Stapler Medical Recall Class II Hospital
Green and Black Reloads Device
18/07/2019 Azurion Interventional Medical Product Defect Class I Hospital
Fluoroscopic X-ray system with Device Correction
software version 1.2
18/07/2019 EV1000 clinical platform Medical Product Defect Class II Hospital
Device Correction
18/07/2019 Fluorostar 7900 System Medical Product Defect Class II Hospital
Device Correction
18/07/2019 HEYEX 2 image management Medical Product Defect Class II Hospital
components of SPECTRALIS PC Device Correction
Software
18/07/2019 Jointrep Cartilage Thermogel Kit Medical Product Defect Class III Hospital
- OLM-JR001 Device Correction
18/07/2019 Monaco version 5.10 or 5.11 Medical Product Defect Class I Hospital
using Elekta motorised wedges Device Correction
18/07/2019 Pulsavac Plus Wound Medical Recall Class II Hospital
Debridement System Device
18/07/2019 QIAsymphony SP instrument Medical Product Defect Class II Hospital
(Software 5.0.3). An in vitro Device Correction
17/07/2019 IMMULITE 2000/2000 XPi - Medical Product Defect Class II Hospital
Progesterone (PRG). An in vitro Device Correction
17/07/2019 ImmunoCAP Tryptase Control. Medical Recall Class II Hospital
device (IVD)
17/07/2019 Mircoaire SmartRelease system Medical Product Defect Class III Hospital
Device Correction
17/07/2019 MULTIGENT Lithium and Alinity Medical Product Defect Class II Hospital
c Lithium Reagents. An in vitro Device Correction
Amphetamines (AMPH) Device Correction
15/07/2019 Azurion Interventional Medical Product Defect Class II Hospital
Fluoroscopic X-ray System, with Device Correction

Datei Levelvi
12/07/2019 Calibration Serum Level 3. An in Medical Product Defect Class II Hospital
(IVD)
12/07/2019 GETINGE Steam Steriliser Medical Product Defect Class II Hospital
Device Correction
12/07/2019 NEUTROGENA Visibly Clear Medical Recall Class II Consumer
Light Therapy Acne Mask and Device
Activator
10/07/2019 Individual GRIPPER Needles Medical Recall Class II Hospital
and PORT-A-CATH Trays Device
containing GRIPPER Needles
9/07/2019 Edwards Lifesciences IntraClude Medical Recall Class I Hospital
Intra-aortic Occlusion Device Device
9/07/2019 SOMATOM Confidence, Medical Product Defect Class II Hospital
SOMATOM Drive, SOMATOM Device Correction
Definition Edge, SOMATOM
Definition AS, SOMATOM
Definition Flash, SOMATOM
Edge Plus, SOMATOM Force
with software syngo CT VB10A
9/07/2019 VIP RIA (Vasoactive Intestinal Medical Recall Class II Hospital
Polypeptide) kits. An in vitro Device
8/07/2019 BD Connecta Plus3 White (3 Medical Recall Class II Hospital
way stopcock) Device
8/07/2019 Morcher Capsular Tension Rings Medical Recall Class II Hospital
Type 13 Right, Type 13A Right Device
and Type 13B Right
8/07/2019 Phadia 1000 instrument. An in Medical Product Defect Class II Hospital
(IVD)
8/07/2019 TechnegasPlus Generator Medical Product Defect Class II Hospital
Device Correction
5/07/2019 MAC VU360 systems Medical Product Defect Class II Hospital
Device Correction
5/07/2019 Tina-quant Myoglobin Gen. 2 for Medical Product Defect Class I Hospital
use on cobas c 311 analysers Device Correction
and cobas c 501/502 modules.
device (IVD)
4/07/2019 MAGEC System Medical Hazard Alert Class II Hospital
Device
4/07/2019 Mako System SS2U Computer Medical Product Defect Class III Hospital
Device Correction
3/07/2019 ADVIA 120/2120/2120i Diff Medical Recall Class III Hospital
Timepac Assays. An in vitro Device
2/07/2019 AQUIOS IMMUNO-TROL Low Medical Recall Class II Hospital
Cells. An in vitro diagnostic Device
2/07/2019 CT Expres Day Set III Medical Recall Class II Hospital
Device

Datei Levelvi
2/07/2019 DRX-Ascend and Q-Rad System Medical Product Defect Class II Hospital
Overhead Tube Crane (OTC) Device Correction
Assembly
2/07/2019 Revolution CT Scanners Medical Product Defect Class II Hospital
Device Correction
2/07/2019 Spectrum Medical Quantum Medical Product Defect Class II Hospital
Perfusion Systems Device Correction
28/06/2019 iGUIDE 2.2 Medical Product Defect Class II Hospital
Device Correction
28/06/2019 Stainless Steel Interstitial Medical Recall Class II Hospital
Needles, 17 Gauge Device
27/06/2019 Various Evolutis Femoral Rasps Medical Recall Class III Hospital
Device
24/06/2019 Various GlidePath Standard and Medical Recall Class II Hospital
Haemodialysis Catheters Device
Module. An in vitro diagnostic Device Correction
21/06/2019 BD MaxZero Needleless Medical Product Defect Class II Hospital
Connector and associated Device Correction
Extension Sets
21/06/2019 MID-Tube, Orogastric calibration Medical Recall Class II Hospital
Tube Device
20/06/2019 cobas 6800 System. An in vitro Medical Product Defect Class II Hospital
20/06/2019 Fluoron F-Octane and F-Decalin Medical Recall Class II Hospital
(syringe delivery format) Device
20/06/2019 Tenor Passive Floor Lift Medical Product Defect Class III Hospital
Device Correction
19/06/2019 BrightView SPECT, BrightView Medical Product Defect Class II Hospital
X, BrightView XCT Device Correction
18/06/2019 ACUSON SC2000 VB20 and Medical Product Defect Class III Hospital
VB21 and the eSie Flow Device Correction
software (SW) license
18/06/2019 ARCHITECT Ceruloplasmin Medical Product Defect Class II Hospital
Reagent Kit and Alinity c Device Correction
Ceruloplasmin Reagent Kit. An in
(IVD)
18/06/2019 DiaClon Rh-Subgroups + K. An Medical Product Defect Class III Hospital
(IVD)
18/06/2019 OVC3 16.17L A3 Refills Medical Recall Class III Hospital
Device
18/06/2019 UX-2000 Fully Automated Medical Product Defect Class III Hospital
Integrated Urine Analyser. An in Device Correction
(IVD)
17/06/2019 ACHRAb RIA kits. An in vitro Medical Recall Class II Hospital

Datei Levelvi
17/06/2019 ALT/GPT, Creatine Kinase and Medical Product Defect Class II Hospital
Glucose HK assays. An in vitro Device Correction
17/06/2019 Comprehensive Reverse Medical Recall Class II Hospital
Shoulder Instrument Case – Device
Total (Outer Case Vault Only)
14/06/2019 6F Sherpa NX Active Catheters Medical Recall Class II Hospital
Device
14/06/2019 ARTIS zee and AXIOM Artis Medical Product Defect Class II Hospital
systems with generator A100 Device Correction
14/06/2019 ZOLL AED PRO Product Family Medical Product Defect Class I Hospital
Device Correction
12/06/2019 Artis zee and Artis Q systems Medical Product Defect Class II Hospital
Device Correction
12/06/2019 Assayed Bovine Multi-Sera - Medical Product Defect Class II Hospital
Level 1. An in vitro diagnostic Device Correction
12/06/2019 SterilAmp SA/6 Certificate of Medical Product Defect Class III Hospital
Analysis Device Correction
12/06/2019 SYNCHRON Systems Medical Recall Class II Hospital
Phosphorus Reagent (PHOSm). Device
An in-vitro diagnostic medical
device (IVD)
11/06/2019 BD Microtainer Tubes. An in vitro Medical Recall Class II Hospital
7/06/2019 Senographe Pristina with Serena Medical Product Defect Class II Hospital
7/06/2019 Spectra Optia Apheresis System Medical Product Defect Class II Hospital
Device Correction
5/06/2019 BD Alaris Pump Model 8100 Medical Recall Class I Hospital
Infusion Sets and Alaris Infusion Device
Sets
5/06/2019 Philips Incisive Computed Medical Product Defect Class II Hospital
Tomography X-Ray System Device Correction
5/06/2019 Rifton Tram and E -Pacer - Medical Product Defect Class II Retail
Standard and Low Leg Device Correction
5/06/2019 Sheridan Endotracheal Tubes Medical Product Defect Class II Hospital
and Connectors, 15mm Device Alert
4/06/2019 Elecsys Syphilis 200 tests. An in Medical Product Defect Class II Hospital
(IVD)
4/06/2019 Filter-Tips, 1500 µl (1024) used Medical Recall Class II Hospital
with QIAsymphony SP/AS Device
Instruments. An in vitro
3/06/2019 ECG Trunk Cables and Medical Product Defect Class I Hospital
Leadwires Device Correction
31/05/2019 Alinity i BNP Calibrators and Medical Recall Class II Hospital
Controls. An in vitro diagnostic Device

Datei Levelvi
31/05/2019 ARCHITECT BNP Calibrators Medical Recall Class II Hospital
and Controls. An in vitro Device
31/05/2019 Sensation Plus 7.5Fr 40cc Intra- Medical Recall Class II Hospital
Aortic Balloon Catheter with Device
Accessories Kits
31/05/2019 SenTech Membrane Changer Medical Recall Class III Retail
and Insert Device
31/05/2019 UniCel DxH 800/600/900 Coulter Medical Product Defect Class I Hospital
Cellular Analysis System. An in Device Correction
(IVD)
30/05/2019 Codan Extension Set Medical Recall Class II Hospital
Device
30/05/2019 HeartStart MRx Medical Product Defect Class I Retail
Defibrillator/Monitor Device Correction
29/05/2019 Human Assayed Control Level 2. Medical Product Defect Class II Hospital
advice (IVD).
29/05/2019 HyLED Surgical Light Series 7, 8 Medical Product Defect Class II Hospital
and 9 Device Correction
29/05/2019 J623 Power Wheel Chairs Medical Product Defect Class II Consumer
("Jazzy 623") fitted with Dynamic Device Correction
Controls Shark Power Module
28/05/2019 Diluent Tubing on the CELL-DYN Medical Recall Class II Hospital
Emerald Analyser. An in vitro Device
28/05/2019 Multiple ARCHITECT Assays. An Medical Product Defect Class II Hospital
(IVD)
28/05/2019 Various Adjustable Crutches Medical Recall Class III Retail
Device
24/05/2019 Covidien Endo GIA Articulating Medical Recall Class II Hospital
Reloads with Tri-Staple Device
Technology
24/05/2019 Multiple Alinity c Assays. An in Medical Product Defect Class II Hospital
(IVD)
22/05/2019 CEM-530 Specular Microscope Medical Product Defect Class II Hospital
Device Correction
22/05/2019 Tilt & Recline Shower Commode: Medical Product Defect Class II Consumer
Aspire, 46cm and 53cm Device Correction
22/05/2019 twinSys impactor with offset Medical Recall Class II Hospital
Device
21/05/2019 Alaris System Pump module Medical Product Defect Class I Hospital
(LVP) 8100 Device Correction

Datei Levelvi
21/05/2019 Draeger Patient Monitors; Medical Product Defect Class III Hospital
Delta/Delta XL/Kappa Device Correction
21/05/2019 LVivo EF app on Vscan Extend Medical Product Defect Class II Hospital
Device Correction
21/05/2019 MAGNETOM Vida and Sola with Medical Product Defect Class II Hospital
syngo MR XA11 software Device Correction
21/05/2019 Radiometer ABL800 series Medical Product Defect Class II Hospital
analysers. An in vitro diagnostic Device Correction
20/05/2019 3M Steri-Strip Elastic Skin Medical Product Defect Class III Retail
Closures, E4540 Device Correction
20/05/2019 Curam Duo 400/57mg Powder Medicine Recall Class II Consumer
For Oral Suspension,
(amoxycillin/clavulanic acid)
60mL
20/05/2019 Philips Incisive Computed Medical Product Defect Class III Hospital
Tomography X-Ray System Device Correction
17/05/2019 GETINGE WD15 Claro – Medical Product Defect Class II Hospital
Washer Disinfector Device Correction
17/05/2019 GMK UNI Femur sizes 3 & 4 - Medical Hazard Alert Class II Hospital
non anatomic version Device
17/05/2019 Horizon Cardiology Hemo and Medical Product Defect Class I Hospital
McKesson Cardiology Hemo Device Correction
17/05/2019 Wombat Living size 3 Medical Product Defect Class II Retail
Device Correction
16/05/2019 DEFIGARD Touch 7 Medical Product Defect Class I Hospital
Device Correction
16/05/2019 iQ Control/Focus Set. An in vitro Medical Product Defect Class III Hospital
16/05/2019 Medicina ENFit NGP and Ryles Medical Product Defect Class II Hospital
Nasogastric Feeding Tubes Device Correction
16/05/2019 Orbera Intragastric Balloon Medical Product Defect Class I Retail
System and BIB Intragastric Device Correction
Balloon System
16/05/2019 Philips IntelliVue Information Medical Product Defect Class III Hospital
Center iX / Patient Information Device Correction
Center iX IntelliBridge System
16/05/2019 Portico Solo Re-Collapsible Medical Recall Class I Hospital
Access System Device
16/05/2019 Power Express Sample Medical Product Defect Class II Hospital
Processing System. An in vitro Device Correction
16/05/2019 Various Gastric Tubes and Medical Recall Class I Hospital
Catheters Device
16/05/2019 Various oral complementary Medicine Recall Class I Consumer
medicines containing Fallopia
multiflora from Global
Therapeutics
16/05/2019 Various Schiller Defibrillation Medical Recall Class I Consumer
Electrodes Device

Datei Levelvi
13/05/2019 BD PhaSeal C61 Secondary Set Medical Recall Class I Hospital
Device
13/05/2019 BVI Ophthalmic Instrument Medical Recall Class III Hospital
Wipes and Wicks Device
13/05/2019 Creatine Kinase on the ADVIA Medical Recall Class II Hospital
Chemistry Platform. An in vitro Device
13/05/2019 Creatine Kinase on the Atellica Medical Recall Class II Hospital
Chemistry Platform. An in vitro Device
13/05/2019 O-ARM 1000 Imaging System Medical Product Defect Class II Hospital
Device Correction
10/05/2019 BILT3 and LACT2 assays for use Medical Product Defect Class III Hospital
on the Cobas Integra 400 plus Device Correction
9/05/2019 Achilles EXPII Systems with Medical Product Defect Class II Hospital
power cords Device Correction
8/05/2019 All Philips EPIQ & Affiniti Medical Product Defect Class I Hospital
Ultrasound Systems with Device Correction
8/05/2019 ARCHITECT c Systems Mixer. Medical Product Defect Class II Hospital
An in vitro medical device (IVD) Device Correction
8/05/2019 Medtronic HeartWare Monitor Medical Product Defect Class II Hospital
AC Adapter Device Correction
6/05/2019 Atellica UAS 800 Analyser. An in Medical Product Defect Class III Hospital
(IVD).
6/05/2019 Immunohaematology control - Medical Product Defect Class I Hospital
IH-QC1. An in vitro diagnostic Device Correction
6/05/2019 LymphoTrack Dx PGM s/w Medical Product Defect Class III Hospital
v2.4.4 or older supplied with Device Correction
Product # IV91210057 &
LymphoTrack Dx IGH FR1/2/3
Assay – PGM. An in vitro
6/05/2019 MAHURKAR acute catheters Medical Product Defect Class I Hospital
Device Correction
6/05/2019 Matrx Digital MDM Mixer Medical Product Defect Class II Retail
Device Correction
6/05/2019 Prismaflex Sets Medical Product Defect Class II Hospital
Device Alert
6/05/2019 SureTyper Software v6.0.0 - Medical Product Defect Class III Hospital
STTPGRX. An in vitro diagnostic Device Correction
3/05/2019 IntelePACS software versions Medical Product Defect Class III Hospital
4.11.1 and later Device Correction
3/05/2019 MitraClip XTR Clip Delivery Medical Product Defect Class I Hospital

Datei Levelvi
3/05/2019 Philips SureSigns VS3/VS4 Medical Product Defect Class I Retail
Monitors Device Correction
3/05/2019 Prismaflex Devices with software Medical Product Defect Class II Hospital
version 8.10 Device Correction
2/05/2019 2.7 Degree Angled Sagittal Saw Medical Recall Class II Hospital
attachment and 2.7 Degree Device
Straight Sagittal Saw attachment
2/05/2019 IMMAGE Immunochemistry Medical Recall Class II Hospital
Systems Immunoglobulin M Device
(IGM) Reagent. An in vitro
2/05/2019 lntroFlex lntroducers Medical Recall Class II Hospital
Device
2/05/2019 Solero Microwave Tissue Medical Product Defect Class II Hospital
Ablation (MTA) System, Device Correction
Generator and Applicators
2/05/2019 Xenform Soft Tissue Repair Medical Recall Class I Hospital
Matrix and Pinnacle LITE Pelvic Device
Floor Repair Kit, Posterior
1/05/2019 EnCor Breast Biopsy Probes Medical Product Defect Class II Hospital
Device Correction
1/05/2019 VOLISTA light head Medical Product Defect Class II Hospital
Device Correction
30/04/2019 Access Free T3, Access Total Medical Product Defect Class II Hospital
T3, Access Free T4, Access GI Device Correction
Monitor (GI Mon), Access
Thyroglobulin (Tg), Access
Thyroglobulin Antibody II
(TgAbII). An in vitro diagnostic
30/04/2019 Alere NT-proBNP. An in vitro Medical Recall Class II Hospital
30/04/2019 Monoject Standard Hypodermic Medical Recall Class II Hospital
Needle, 14 G x 1-1/2 Device
30/04/2019 SOMATOM go. systems with s/w Medical Product Defect Class II Hospital
version VA20A, VA20A_SP0 or Device Correction
VA20A_SP1 to VA20A_SP2
30/04/2019 Sysmex SP-50 slidemaker- Medical Product Defect Class II Hospital
stainer. An in vitro diagnostic Device Correction
30/04/2019 Zenith Alpha Abdominal Medical Recall Class I Hospital
Endovascular Graft Device
26/04/2019 Alvarado Knee Holder Base Medical Recall Class II Hospital
Plate Assembly and Foot Piece Device
& Alvarado II Base Plate and
Foot Piece
26/04/2019 Kwart Retro-Inject Stent Sets Medical Product Defect Class III Hospital
and Salle Intraoperative Device Correction
Pyeloplasty Stent Sets
26/04/2019 Technetium-99m Cardiolite Medicine Recall Class II Hospital
26/04/2019 Weleda Baby Teething Powder Medicine Recall Class I Consumer
60g

Datei Levelvi
24/04/2019 3M Reston Self-Adhering Foam Medical Product Defect Class II Hospital
Pads Device Correction
24/04/2019 Alinity c Cuvette Segment. An in Medical Product Defect Class II Hospital
(IVD)
24/04/2019 Biograph Vision 600 and Medical Product Defect Class II Hospital
Biograph Vision 600 Edge (with Device Correction
VG75A or B software and the
PATLAK reconstruction license)
24/04/2019 Thermistor for Cooling Unit. An Medical Product Defect Class III Hospital
(IVD)
18/04/2019 ACDA Anticoagulant Solution Medical Recall Class II Hospital
Device
18/04/2019 Carestream Onsight 3D Medical Product Defect Class II Hospital
Extremity System Device Correction
18/04/2019 Diode Fibers used with Dornier Medical Recall Class II Hospital
Standard Diode and Nd:YAG Device
Lightguides
18/04/2019 Liaison XL and Liaison XL LAS Medical Product Defect Class II Hospital
with POM Stirrer Bar M. An in Device Correction
(IVD).
18/04/2019 Medwarm neonate and Medical Recall Class I Hospital
Medwarm neonate with Skin Device
temp port and probe
18/04/2019 Philips Intellivue MX40 Patient Medical Product Defect Class I Hospital
Worn Monitors Device Correction
18/04/2019 VITEK MS Preparation Station Medical Product Defect Class III Hospital
software. An in vitro diagnostic Device Correction
17/04/2019 LimiTorr Volume Limiting Medical Product Defect Class II Hospital
External CSF Drainage and Device Correction
Monitoring Systems
17/04/2019 Various Foot and Ankle Medical Recall Class II Hospital
Instruments (Drill / Tap and Device
Countersink)
16/04/2019 Various ARTIS zee and ARTIS Medical Product Defect Class II Hospital
Q/Q.zen systems Device Correction
15/04/2019 RÜSCH Lasertube Medical Recall Class II Hospital
Device
15/04/2019 Swan-Ganz Thermodilution Medical Product Defect Class II Hospital
Catheter Double Lumen Device Correction
12/04/2019 T7 Cannulated Driver AO and T7 Medical Recall Class II Hospital
Driver Solid AO Device
11/04/2019 Alinity i Processing Module. An Medical Product Defect Class II Hospital
(IVD).
11/04/2019 Chromophare F 528/F 628 Medical Product Defect Class II Hospital
Surgical Lights Device Correction

Datei Levelvi
11/04/2019 Covidien Emprint Percutaneous Medical Product Defect Class I Hospital
Antennas with Thermosphere Device Correction
Technology
11/04/2019 CyberKnife M6 and CyberKnife Medical Product Defect Class II Hospital
VSI Secondary Collimation Device Correction
Subsystem with software version
11.x
11/04/2019 Mercury Advance V1 Control Medical Recall Class II Hospital
Unit Device
11/04/2019 MobileDiagnost wDR Medical Product Defect Class II Hospital
Device Correction
11/04/2019 OXOID MICE Strip MA0122 – Medical Recall Class II Hospital
Ceftriaxone32. An in vitro Device
11/04/2019 TactiSys Quartz Equipment Medical Product Defect Class II Hospital
operating on Software Version Device Correction
1.7.0
10/04/2019 Pericardiocentesis Catheter Set Medical Recall Class II Hospital
Device
9/04/2019 Microbore Y-Type Extension Set Medical Recall Class II Hospital
and Catheter Extension Set with Device
Clearlink - Male Luer Lock
Adapter
9/04/2019 Mobile OR-Table MEERA Medical Product Defect Class I Hospital
Device Correction
8/04/2019 Auriga 30 Laser System Medical Product Defect Class II Hospital
Device Correction
8/04/2019 CSZ Haemotherm 400CE Medical Recall Class I Hospital
System Device
5/04/2019 HeartMate 3 LVAD implant Medical Recall Class II Hospital
Device
5/04/2019 Visiwipe Instrument Wipe 73 x Medical Recall Class III Hospital
73mm Device
5/04/2019 Wolf 445nm Medical Product Defect Class II Hospital
Device Correction
4/04/2019 Alinity hq Analyser. An in vitro Medical Product Defect Class II Hospital
4/04/2019 Cios Spin Medical Product Defect Class II Hospital
Device Correction
4/04/2019 Philips Access CT Systems Medical Product Defect Class III Hospital
Device Correction
4/04/2019 RealTime HBV Control Kit and Medical Product Defect Class III Hospital
RealTime CMV Control Kit. An in Device Correction
(IVD)

Datei Levelvi
4/04/2019 Single-patient use drills for Medical Recall Class II Retail
NobelReplace (Tapered Drills, Device
Dense Bone Drills, Screw Taps),
Guided Start Drills/Counterbores
and Guided Counterbores for
NobelReplace, Implant Retrieval
Instruments and Abutment
Screw Retrieval Instruments
3/04/2019 Custom Tubing Sets Medical Recall Class I Hospital
Device
3/04/2019 Drager Infinity Acute Care Medical Product Defect Class II Hospital
System (IACS) and Infinity M540 Device Correction
Stand Alone Patient Monitor
3/04/2019 G-6-PDH Deficient and Normal Medical Product Defect Class I Hospital
Control. An in vitro diagnostic Device Correction
3/04/2019 Lypochek Specialty Medical Product Defect Class II Hospital
Immunoassay Control. An in vitro Device Correction
3/04/2019 VariFit Sterile Single Use Adult Medical Recall Class II Hospital
Thigh Cuffs, Single Port, Single Device
Bladder
2/04/2019 Atellica CH 930 Analyser. An in Medical Product Defect Class III Hospital
(IVD).
2/04/2019 Dräger Disposable VentStar Medical Product Defect Class I Hospital
Helix Dual Heated Breathing Device Correction
Circuit
2/04/2019 FilmArray - Blood Culture Medical Product Defect Class II Hospital
Identification (BCID) Panel used Device Correction
with bioMérieux BACT/ALERT
Blood Culture Bottles. An in vitro
2/04/2019 Intraluminal Staplers (ILS) Medical Product Defect Class I Hospital
Device Correction
2/04/2019 MAJ-209 Suction Valve Medical Product Defect Class II Hospital
Device Correction
1/04/2019 Aisys Anaesthesia Devices Medical Product Defect Class I Hospital
Device Correction
1/04/2019 Hamilton C6 Ventilators Medical Product Defect Class II Hospital
Device Correction
29/03/2019 Heater-Cooler 3T, 230V Medical Product Defect Class II Hospital
Device Correction
29/03/2019 Mylanta Antacid Double Strength Medicine Product Defect Class III Consumer
500 mL oral liquid bottle Correction
29/03/2019 RT Elements Radiation Medical Product Defect Class I Hospital
Treatment Planning Software Device Correction
29/03/2019 VITROS XT 7600 Integrated Medical Product Defect Class I Hospital
System. An in vitro diagnostic Device Correction

Datei Levelvi
27/03/2019 cobas p 701 post-analytical Medical Product Defect Class II Hospital
units. An in vitro diagnostic Device Correction
27/03/2019 TM55 Stress Testing Treadmills Medical Product Defect Class II Hospital
Device Correction
26/03/2019 Drill Mini-Trephination 2.0mm Medical Recall Class II Hospital
Device
26/03/2019 Freedom EVOlyzer 2 150/8. An Medical Product Defect Class III Hospital
(IVD)
26/03/2019 Miller and Fogarty Medical Recall Class I Hospital
Atrioseptostomy Catheters Device
25/03/2019 Dang Gui Yin Zi (Tangkuei & Medicine Recall Class II Consumer
Tribulus combination)
25/03/2019 syngo.CT Cardiac Function and Medical Product Defect Class II Hospital
syngo.CT Cardiac Planning Device Correction
22/03/2019 Cios Alpha VA20 Systems Medical Product Defect Class II Hospital
Device Correction
22/03/2019 Connection Lead SP (12V) for Medical Recall Class II Hospital
Infusomat Space, Infusomat Device
Space P and Perfusor Space
22/03/2019 Femoral Head, living donor - Biological Hazard Alert Class II Hospital
bone, morselised, frozen,
irradiated
21/03/2019 ProCell II M for use on cobas e Medical Product Defect Class I Hospital
801 analytical unit. An in vitro Device Correction
20/03/2019 da Vinci Xi / X Erbe Footswitch Medical Product Defect Class III Hospital
Device Correction
20/03/2019 Femoral head, living donor - Biological Hazard Alert Class II Hospital
bone, morsellised, frozen,
irradiated
20/03/2019 Leica Biosystems Cryostat Medical Product Defect Class II Hospital
Devices. An in vitro diagnostic Device Correction
20/03/2019 Shui An and Yang Xue Sheng Fa Medicine Recall Class II Consumer
Capsules
19/03/2019 Arthrem capsules Medicine Product Defect Class II Retail
Correction
19/03/2019 F-18 FDG Injection Medicine Product Defect Class III Hospital
(Fludeoxyglucose F18) Correction
19/03/2019 Giraffe Bedded Warmers and Medical Product Defect Class I Hospital
Panda iRes Warmers Device Correction
19/03/2019 IMAGEnet 6 Ophthalmic Data Medical Product Defect Class II Retail
19/03/2019 Polished Finned 1 Piece Tibial Medical Hazard Alert Class II Hospital
Tray 71mm Device
18/03/2019 A610 DBS Clinician Programmer Medical Product Defect Class II Hospital
Application Device Correction

Datei Levelvi
18/03/2019 Albumin BCP. An in vitro Medical Product Defect Class I Hospital
18/03/2019 Glyceryl Trinitrate 300mcg Medicine Recall Class II Retail
Tablets 100, Martindale UK
18/03/2019 Stephanix D2RS System Medical Product Defect Class II Hospital
Device Correction
18/03/2019 VAMP Optima Blood Sampling Medical Recall Class II Hospital
System Device
15/03/2019 Complementary Medicines Medicine Recall Class II Consumer
Containing Fallopia Multiflora -
Herbal International
15/03/2019 Mobility Plus Wheelchairs - Medical Product Defect Class II Consumer
Malte, Malte-Outdoor and Marcy Device Correction
14/03/2019 ALBAClone Anti-Leb. An in vitro Medical Recall Class II Hospital
14/03/2019 Alinity ci-series Software version Medical Product Defect Class II Hospital
14/03/2019 Atellica Solution Products. An in Medical Product Defect Class II Hospital
(IVD)
14/03/2019 Canon XR System DRAD- Medical Product Defect Class II Hospital
3000E/W8, Radrex with Wireless Device Correction
FPD
14/03/2019 Infinity Acute Care System Medical Product Defect Class I Hospital
(IACS) and Infinity M540 Stand Device Correction
Alone Monitor
13/03/2019 enFlow Fluid Warming System Medical Recall Class I Hospital
Device
13/03/2019 VICRYL Absorbable Suture Medical Recall Class II Hospital
Device
12/03/2019 Lafomed Premium B Class Medical Product Defect Class III Retail
Autoclaves Device Correction
12/03/2019 MultiDiagnost-Eleva, Medical Product Defect Class II Hospital
OmniDiagnost-Eleva and Device Correction
OmniDiagnost-Classic
12/03/2019 Speedlock Knotless Fixation Medical Product Defect Class III Hospital
Implants Device Correction
8/03/2019 GlideScope Go Video Medical Product Defect Class III Hospital
Laryngoscopy System Device Correction
7/03/2019 FilmArray Gastrointestinal (GI) Medical Product Defect Class II Hospital
Panel. An in vitro diagnostic Device Correction
7/03/2019 Genex Putty 5cc Medical Recall Class II Hospital
Device
7/03/2019 Hamilton G5/S1 Ventilators Medical Product Defect Class I Hospital
Device Correction
7/03/2019 Radiometer TCM5 FLEX/ BASIC Medical Recall Class I Hospital
Transcutaneous Monitor Device

Datei Levelvi
7/03/2019 TrueBeam Radiotherapy System Medical Product Defect Class II Hospital
with Visual Coaching Device or Device Correction
EDGE or VitalBeam
6/03/2019 Alinity hq Analyser and Alinity hs Medical Product Defect Class II Hospital
Slide Maker Stainer Module. An Device Correction
(IVD)
6/03/2019 Arjo SARA 3000, Tenor and Medical Product Defect Class III Hospital
Minstrel Patient Lifts Device Correction
6/03/2019 ChromID CPS/Horse Blood Medical Recall Class II Hospital
Agar. An in vitro diagnostic Device
5/03/2019 Alinity c and Alinity i Analysers. Medical Product Defect Class II Hospital
device (IVD)
5/03/2019 MultiDiagnost-Eleva with Flat Medical Product Defect Class II Hospital
Detector and Allura Xper Device Correction
5/03/2019 Smartstitch PerfectPasser Medical Recall Class II Hospital
Connector Device
4/03/2019 ImmunoCAP ISAC sIgE 112. An Medical Recall Class II Hospital
(IVD).
4/03/2019 Pulmonary Vein Ablation Medical Product Defect Class I Hospital
Catheter GOLD (PVAC GOLD) Device Correction
4/03/2019 StentBoost Release 4.0, 4.1 and Medical Product Defect Class III Hospital
4.2 Device Correction
1/03/2019 3.4mm Certain BellaTek Medical Recall Class II Retail
Abutment, ILDAT3 Device
1/03/2019 BD Phoenix AST Indicator and Medical Recall Class II Hospital
BD Phoenix AP AST-S Indicator Device
Bag. An in vitro diagnostic
1/03/2019 StealthStation Cranial and Medical Product Defect Class II Hospital
Synergy Cranial Software Device Correction
28/02/2019 ARIA Radiation Therapy Medical Product Defect Class II Hospital
Management Device Correction
28/02/2019 Dialysis start/stop set - FMC Medical Recall Class II Hospital
Dialysis Fistula Pack #61 Device
28/02/2019 Edge Radiosurgery System or Medical Product Defect Class III Hospital
TrueBeam and VitalBeam Device Correction
Radiotherapy Systems
28/02/2019 neoBLUE blanket LED Medical Product Defect Class II Hospital
Phototherapy Systems Device Correction
28/02/2019 Spine & Trauma 3D Navigation Medical Product Defect Class II Hospital
System 1.0 Device Correction
28/02/2019 VariSeed 9.0 or Vitesse 3.0 Medical Product Defect Class II Hospital
Device Correction
28/02/2019 Velocity Advanced Imaging [AI], Medical Product Defect Class II Hospital
Velocity Advanced Imaging Device Correction
Solutions [AIS] or VelocityGRID

Datei Levelvi
28/02/2019 Velocity Advanced Imaging [AI], Medical Product Defect Class II Hospital
Velocity Advanced Imaging Device Correction
Solutions [AIS] or VelocityGRID
27/02/2019 Arjo Sara Plus Lift Medical Product Defect Class III Hospital
Device Correction
27/02/2019 Bivona Inner Cannula Medical Product Defect Class II Hospital
Tracheostomy Tube Device Correction
27/02/2019 THERA-Trainer balo / THERA- Medical Product Defect Class II Hospital
Trainer verto Device Correction
26/02/2019 CELL-DYN Emerald Analyser. Medical Product Defect Class II Hospital
device (IVD)
26/02/2019 GENTECH Medicine Recall Class II Hospital
Molybdenum(99Mo)/Technetium(
99mTc) sterile Generator for
production of Sodium
pertechnetate (99mTc) injection
multidose vial
26/02/2019 Inferior Vena Cava (IVC) Filter Medical Product Defect Class III Hospital
Sets Device Correction
26/02/2019 Medtronic Model 37751 Medical Product Defect Class I Hospital
Recharger, in Charging Systems Device Correction
used with implantable
neurostimulators
22/02/2019 18Gx1-1/2IN TW Precision Glide Medical Recall Class III Hospital
Needles Device
21/02/2019 Ardo Sterile Tulips Nipple Medical Recall Class II Hospital
Shields, Medium and Large Device
21/02/2019 Maquet Cardiopulmonary Pre- Medical Product Defect Class II Hospital
Bypass Filters used for Device Correction
Customised Tubing Packs
20/02/2019 Dräger BabyLeo TN500 Medical Product Defect Class III Hospital
Incuwarmer Device Correction
Device
19/02/2019 Citracal Plus D Medicine Recall Class III Retail
19/02/2019 Duodenovideoscope TJF-160VR Medical Product Defect Class II Hospital
Device Correction
19/02/2019 Multiple SOMATOM CT Medical Product Defect Class II Hospital
Scanners - syngo CT VB10A Device Correction
with Option Dual Spiral Dual
Energy
19/02/2019 Obturator, short cone 7" and Medical Recall Class II Hospital
long cone 10" Device
19/02/2019 Terumo Needles Medical Recall Class II Hospital
Device
15/02/2019 Access Thyroglobulin Antibody II Medical Recall Class II Hospital
(TgAbII) Reagent. An in vitro Device

Datei Levelvi
14/02/2019 Bard Lifestream Balloon Medical Product Defect Class I Hospital
Expandable Vascular Covered Device Correction
Stent
14/02/2019 Laryseal Flexi Laryngeal Mask Medical Recall Class II Hospital
sizes 2 and 4 Device
14/02/2019 Mobile X-Ray System Medical Product Defect Class II Hospital
MobileDaRt Evolution Handle Device Correction
(MX8 Version)
13/02/2019 Alinity hq Analyser. An in vitro Medical Product Defect Class II Hospital
13/02/2019 BonAlive Putty MIS 5cc Medical Product Defect Class III Hospital
Device Correction
13/02/2019 Volcano Philips s5i/CORE/Core Medical Product Defect Class II Hospital
Mobile systems with software Device Correction
v2.5 FFR/IFR
13/02/2019 Xia 3 Degen Tray and French Medical Product Defect Class II Hospital
Bender instrument Device Correction
12/02/2019 Cordis Vista Brite Tip & ADROIT Medical Recall Class II Hospital
Guiding Catheters Device
12/02/2019 JURNISTA hydromorphone Medicine Product Defect Class II Consumer
hydrochloride 8 mg prolonged Correction
release 14 tablet blister pack
12/02/2019 Uroskop Omnia / Uroskop Omnia Medical Product Defect Class II Hospital
Max Device Correction
11/02/2019 CL2 Femoral Stem, Standard Medical Product Defect Class III Hospital
Offset, Collarless, Taper 12/14 - Device Correction
Size 8
11/02/2019 Panda iRes Warmer with Medical Product Defect Class II Hospital
ResusView Heart Rate Feature Device Correction
11/02/2019 Radimetrics CDM Software Medical Product Defect Class II Hospital
Device Correction
8/02/2019 ARCHITECT and Alinity i Medical Product Defect Class II Hospital
Estradiol Reagent Kits. An in Device Correction
(IVD)
8/02/2019 Certegra Workstation 1.0, Medical Product Defect Class II Hospital
software version 4.5 Device Correction
8/02/2019 LIFEPAK 15 Monitor/Defibrillator Medical Product Defect Class I Retail
& LIFEPAK 15 Device Correction
Monitor/Defibrillator Repair
Service Kit
8/02/2019 Sample Probe Cover for Aptio by Medical Product Defect Class III Hospital
Siemens, Aptio by Inpeco and Device Correction
FlexLab Automation Interfaces
connected to ADVIA Chemistry
XPT. An in vitro diagnostic
8/02/2019 Various Immunoassay Controls Medical Product Defect Class II Hospital
used with Siemens Immulite Device Correction
2000. An in vitro diagnostic

Datei Levelvi
6/02/2019 ARIA OIS for Radiation Medical Product Defect Class II Hospital
Oncology version 15.5 MR1 Device Correction
6/02/2019 Eclipse Treatment Planning Medical Product Defect Class III Hospital
4/02/2019 ACUSON NX2 / NX2 Elite and Medical Product Defect Class II Hospital
ACUSON NX3 / NX3 Elite Device Correction
systems
4/02/2019 Coarse Milled Bone, Femoral Biological Hazard Alert Class II Hospital
Head
4/02/2019 NARDIL phenelzine 15mg (as Medicine Recall Class II Wholesale
sulfate) tablet bottle
4/02/2019 Percuvance Percutaneous Shaft Medical Recall Class II Hospital
29cm Device
1/02/2019 Edwards Commander Delivery Medical Product Defect Class II Hospital
1/02/2019 SISS BABYCONTROL Medical Product Defect Class II Hospital
Respiration monitors Device Correction
1/02/2019 TrueBeam RadioTherapy Medical Product Defect Class III Hospital
Delivery System Device Correction
1/02/2019 VariSource HDR and Medical Product Defect Class II Hospital
GammaMed Device Correction
31/01/2019 Medical Grade Carbon Dioxide Medicine Product Defect Class III Hospital
Cylinders, C Size Correction
31/01/2019 NutriVital Premium Magnesium Medicine Recall Class II Retail
Complete 100 Tablets
31/01/2019 OVC3 (One Visit Crown) 24/25 L Medical Recall Class III Retail
A2 Device
31/01/2019 OVC3 Hybrid Molar refill A3 - Medical Recall Class III Retail
36.37 L Device
30/01/2019 AXIUS Blower / Mister Medical Recall Class II Hospital
Device
30/01/2019 BioPlex 2200 ANA Screen Medical Product Defect Class III Hospital
Control Set. An in vitro Device Correction
30/01/2019 OVC (One Visit Crown) Starter Medical Recall Class III Hospital
Kit Package containing OVC3 Device
16/17s A3 refills
30/01/2019 Perifix Catheter Connector Medical Product Defect Class II Hospital
Device Correction
30/01/2019 STA – VWF:RCo reagent. An in Medical Product Defect Class II Hospital
(IVD)
30/01/2019 UltraTemp Regular Kit and Medical Product Defect Class II Retail
UltraTemp Rez Fast Set Kit Device Correction
29/01/2019 5x75mm Kii Fios Advanced Medical Recall Class II Hospital
Fixation Access System Device
29/01/2019 MYXAZOLE clotrimazole 10 Medicine Recall Class III Retail
mg/g and hydrocortisone acetate
11.2 mg/g cream tube

Datei Levelvi
29/01/2019 Sonosite L25 Needle Guide Medical Recall Class II Hospital
Bracket Device
24/01/2019 EMPOVIR cidofovir 375 mg/5 mL Medicine Recall Class II Wholesale
concentrated injection for
infusion vial
24/01/2019 Ingenuity CT Core 128 Medical Product Defect Class III Hospital
Device Correction
24/01/2019 Philips PageWriter TC Medical Product Defect Class II Hospital
Cardiographs (TC20/30/50/70) Device Correction
22/01/2019 OA/RA Medicine Recall Class II Consumer
22/01/2019 Philips Efficia CM Monitors Medical Product Defect Class II Retail
Device Correction
21/01/2019 Burr Oval 12 Flute 5.5mm x Medical Recall Class II Hospital
13cm Device
21/01/2019 Da Vinci S/SI Harmonic Ace Medical Recall Class II Hospital
Curved Shear Insert Device
21/01/2019 Otto Bock PUSH VALVE/MAG Medical Recall Class II Hospital
VALVE Device
21/01/2019 Swan-Ganz Thermodilution Medical Recall Class II Hospital
Catheter Device
18/01/2019 Edwards Lifesciences IntraClude Medical Product Defect Class II Hospital
Intra-aortic Occlusion Device Device Alert
18/01/2019 Electronic Thermometer supplied Medical Recall Class I Consumer
in Tiny Tots First Aid Kits Device
18/01/2019 NutriVital Premium Glucosamine Medicine Recall Class II Retail
1500 Plus
18/01/2019 VITEK 2 - Card Pouch Integrity. Medical Product Defect Class II Hospital
device (IVD)
16/01/2019 Adapta Dual Chamber Medical Recall Class I Hospital
Pacemakers Device
15/01/2019 ARIA Oncology Information Medical Product Defect Class II Hospital
System for Radiation Oncology, Device Correction
versions 15.1, 15.5 & 15.6
15/01/2019 Baha Tamper-proof Battery Medical Recall Class I Retail
Door, 3pcs Device
14/01/2019 Disposable Cranial Perforator Medical Product Defect Class III Hospital
and Disposable Scalp Clips Device Correction
14/01/2019 Programmer Software Update Medical Product Defect Class II Hospital
Supporting the Micra Device Correction
Transcatheter Pacing System
14/01/2019 XN-10 automated haematology Medical Product Defect Class III Hospital
analysers. An in vitro diagnostic Device Correction
11/01/2019 Acusnare Polypectomy (Duck Bill Medical Recall Class II Hospital
Shaped) Snare Device
11/01/2019 Tritanium PL cages Medical Product Defect Class II Hospital
Device Correction

Datei Levelvi
11/01/2019 UNIVERSA Soft & Firm Ureteral Medical Recall Class II Hospital
Stent Sets, PTFE Wire Guide, Device
Percutaneous Entry Set &
Bander Ureteral Diversion Open-
End Stent Set
11/01/2019 Xper Flex Cardio Patient Medical Product Defect Class II Hospital
10/01/2019 RX Misano Analyser. An in vitro Medical Product Defect Class III Hospital
10/01/2019 Various Suction Catheters, Medical Recall Class II Hospital
Gastro-enteral Tubes, Device
Intermittent Urology Catheters,
Drainage Kits and sterile Urine
Drainage Bags
9/01/2019 Eclipse Treatment Planning Medical Product Defect Class II Hospital
8/01/2019 Max VPC Tray Base & Max VPC Medical Product Defect Class II Hospital
Screw Caddy Brackets Device Correction
7/01/2019 Fabian HFO, Fabian +nCPAP Medical Product Defect Class II Hospital
evolution and Fabian Therapy Device Correction
evolution
7/01/2019 Fabian Therapy and Fabian Medical Product Defect Class II Hospital
+nCPAP evolution Device Correction
7/01/2019 Ingenuity TF PET/CT running Medical Product Defect Class II Hospital
software version 4.0.2 Device Correction
(4.0.0.26645)
7/01/2019 Sandoz Irbesartan 150mg film- Medicine Recall Class II Retail
coated tablets Blister pack 30’s
4/01/2019 FDGEN fludeoxyglucose [18F] Medicine Product Defect Class III Hospital
200MBq/mL to 6000 MBq/mL Correction
injection vial
4/01/2019 FDGEN fludeoxyglucose [18F] Medicine Product Defect Class II Hospital
injection vial
3/01/2019 Various Philips MR Systems Medical Product Defect Class II Hospital
Device Correction
(IVD)
2/01/2019 Dräger Disposable Breathing Medical Product Defect Class I Hospital
Circuit Device Correction
2/01/2019 EliA ANA Positive Control 250 Medical Product Defect Class III Hospital
and EliA ANA Positive Control Device Correction
2500/5000. An in vitro diagnostic
2/01/2019 Leica M525 F20 Microscope Medical Product Defect Class II Hospital
2/01/2019 Panocell-16 Kit. An in vitro Medical Recall Class II Hospital
2/01/2019 Revision femoral neck H60mm Medical Hazard Alert Class II Hospital
lateralised + Screw Device

Datei Levelvi
31/12/2018 Integra MAYFIELD Skull Clamps Medical Product Defect Class II Hospital
Device Correction
24/12/2018 Various Swan-Ganz Catheters Medical Recall Class III Hospital
Device
21/12/2018 BILT3, IGM-2, and LACT2 Medical Product Defect Class III Hospital
Assays. An in vitro diagnostic Device Correction
21/12/2018 Bronchi-cough pill (Qiguanyan Medicine Recall Class II Consumer
Kousu Tanchuanwan)
21/12/2018 COBAS INTEGRA 400 plus Medical Product Defect Class II Hospital
analyser. An in vitro diagnostic Device Correction
21/12/2018 Interactive Precision IO Scan Medical Recall Class III Retail
Adapters (3.00mmD and Device
3.40mmD Platforms)
20/12/2018 ARCHITECT B12 Reagent Kit. Medical Recall Class II Hospital
device (IVD)
20/12/2018 ARCHITECT Rubella IgM Medical Recall Class II Hospital
Reagent Kit. An in vitro Device
20/12/2018 Autostainer Slide Racks. An in Medical Product Defect Class II Hospital
(IVD)
20/12/2018 GETINGE XS32 Flat Screen Medical Product Defect Class II Hospital
Holder Device Correction
20/12/2018 IV Pole Collar for Spectra Optia Medical Product Defect Class III Hospital
Apheresis System Device Correction
20/12/2018 Trima Accel Automated Blood Medical Product Defect Class III Hospital
Collection System Device Correction
20/12/2018 Xyrem (sodium oxybate) 500 Medicine Product Defect Class II Retail
mg/mL oral solution Alert
18/12/2018 GE Carescape One Monitor with Medical Product Defect Class II Hospital
an ECG USB Patient Cable or Device Correction
SPO2 Masimo USB Patient
Cable
18/12/2018 Mako Onlay Insert Extractor Medical Recall Class II Hospital
Device
18/12/2018 StealthAir Percutaneous Pin Medical Recall Class II Hospital
Adapter Device
17/12/2018 Amica Generator, dual ablation Medical Recall Class II Hospital
system (hybrid microwave and Device
radio frequency)
17/12/2018 APO-Valsartan 40/80/160/320mg Medicine Recall Class II Consumer
products
17/12/2018 Bayer Overhead Counterpoise Medical Product Defect Class II Hospital
mounting system Device Correction

Datei Levelvi
17/12/2018 Dimension Vista Intelligent Lab Medical Product Defect Class II Hospital
Systems using a Progard Device Correction
Pretreatment Pack on the
onboard Millipore Water
Purification Module (WPM). An in
(IVD)
17/12/2018 Fructosamine Calibrator, Medical Product Defect Class III Hospital
Fructosamine Control 1 and Device Correction
Control 3. An in vitro diagnostic
17/12/2018 MOSAIQ Radiation Oncology Medical Product Defect Class II Hospital
version Device Correction
17/12/2018 Sandoz IRBESARTAN/HCT Medicine Recall Class II Retail
batches
14/12/2018 ADVIA Centaur aTG. An in vitro Medical Recall Class II Hospital
14/12/2018 Atellica IM Anti-Thyroglobulin. An Medical Recall Class II Hospital
(IVD).
14/12/2018 Power-LOAD (Cot Fastener) Medical Product Defect Class II Hospital
Device Correction
14/12/2018 Various Olympus Grasping Medical Product Defect Class II Hospital
Forceps and Biopsy Forceps Device Correction
13/12/2018 Platinium ICDs and CRT-Ds Medical Product Defect Class I Hospital
Devices Device Correction
13/12/2018 Stryker Visum II LED Surgical Medical Product Defect Class II Hospital
Lighting system - EDS Device Correction
(Equipment Delivery System)
Light Suspensions, Central Axis
12/12/2018 Anatomic Tibial Base Plate for Medical Hazard Alert Class II Hospital
fixed bearing insert cemented, Device
Size 4
12/12/2018 Mako Vizadiscs and Vizadisc Hip Medical Recall Class II Hospital
Tracking Kit Device
12/12/2018 MILRINONE-CLARIS milrinone Medicine Recall Class III Hospital
(as lactate) 10 mg/10 mL
concentrated injection ampoule
12/12/2018 PP2001 HBA Agar Plates. An in Medical Recall Class II Hospital
(IVD).
12/12/2018 Tropisetrion MYX 2mg/mL Medicine Recall Class II Wholesale
solution for injection or infusion
ampoules

Datei Levelvi
12/12/2018 UniCel DxI 600 & 800 Access Medical Product Defect Class II Hospital
Immunoassay Systems & UniCel Device Correction
DxC 660i, 680i, 860i, 880i
Synchron Access Clinical
11/12/2018 Biograph Horizon Medical Product Defect Class II Hospital
Device Correction
11/12/2018 PROXIMATE Haemorrhoidal Medical Recall Class II Hospital
Circular Stapler Device
11/12/2018 Various Signa OpenSpeed, Medical Product Defect Class II Hospital
Infinity, Profile Ovation, Brivo, Device Correction
Optima, Creator and Explorer
MIR System software
10/12/2018 Celsite Safety SST601F 6.5F SI Medical Recall Class II Hospital
- Access Ports Device
10/12/2018 RayOne Trifocal RAO603F + Medical Recall Class II Hospital
10.5 D ADD 3.5 Intraocular Lens Device
10/12/2018 Steelco DS1000 washers Medical Product Defect Class II Hospital
Device Correction
7/12/2018 CORAIL Female Broaches (Size Medical Hazard Alert Class II Hospital
9-20) Device
7/12/2018 Discovery NM 530c and Ventri Medical Product Defect Class II Hospital
Nuclear Medicine system using Device Correction
Premium (automatic) table and
with MS Windows Operating
System
7/12/2018 SHOEBOX Audiometry Standard Medical Product Defect Class III Retail
and Pro V5.1. Device Correction
6/12/2018 MOSAIQ Radiation Oncology Medical Product Defect Class II Hospital
version 2.64 SP9 and higher Device Correction
using Varian True BEAM or
Varian 4D or Siemens RTT
5/12/2018 BD Burette Sets Medical Recall Class II Hospital
Device
5/12/2018 Bililed Maxi+ Phototherapy Unit Medical Product Defect Class II Hospital
Device Correction
4/12/2018 CARESCAPE B850 Monitors; Medical Product Defect Class II Hospital
Version MBC303 Device Correction
4/12/2018 HeartMate 3 Left Ventricular Medical Hazard Alert Class I Hospital
Assist System and Outflow Graft Device
Clip
4/12/2018 MAS Alcohol/Ammonia Control. Medical Product Defect Class II Hospital
device (IVD).
3/12/2018 Cisbio - Chromogranin A (CGA- Medical Product Defect Class II Hospital
ELISA). An in vitro diagnostic Device Correction
3/12/2018 Digital Angiography System Medical Product Defect Class II Hospital
Trinias Device Correction
3/12/2018 Forceps, Coupler – GEM4183C Medical Recall Class II Hospital
Device

Datei Levelvi
3/12/2018 Heater-Cooler Unit HCU 40 - Medical Product Defect Class I Hospital
Flow Sensor Malfunction Device Correction
3/12/2018 TRAJENTA linagliptin 5 mg film- Medicine Recall Class III Wholesale
coated tablet blister pack
28/11/2018 Alinity i Estradiol Reagent Kit & Medical Recall Class II Hospital
Alinity i STAT High Sensitive Device
Troponin. An in vitro diagnostic
28/11/2018 ARTIS biplane systems from Medical Product Defect Class II Hospital
specific production batch Device Correction
28/11/2018 I-View Contrast Enhanced Digital Medical Product Defect Class II Hospital
Mammography, ASY-08109 Device Correction
28/11/2018 O-arm 1000 Imaging System 2nd Medical Product Defect Class II Hospital
Edition - software versions 3.1.6 Device Correction
and earlier
28/11/2018 Sonata ti100 Medical Hazard Alert Class II Hospital
Device
28/11/2018 Syngo.plaza version Medical Product Defect Class II Hospital
VB30A_HF01 and previous Device Correction
software versions
26/11/2018 Balloon Guide Catheters 9F Medical Recall Class II Hospital
Device
26/11/2018 da Vinci Xi Surgical System Arm Medical Product Defect Class II Hospital
Sensor Device Correction
23/11/2018 Medicina CG Nasogastric Tubes Medical Product Defect Class II Hospital
Device Correction
System Battery Charger Device Correction
23/11/2018 Raindrop Corneal Inlay Medical Hazard Alert Class II Retail
Device
22/11/2018 DILART valsartan film-coated Medicine Recall Class II Consumer
tablet blister pack; and DILART
HCT valsartan and
hydrochlorothiazide film-coated
tablet blister pack
22/11/2018 Dräger Jaundice Meter Medical Product Defect Class II Hospital
Device Correction
21/11/2018 Covidien Emprint Percutaneous Medical Recall Class I Hospital
Antennas with Thermosphere Device
Technology
21/11/2018 Philips IntelliVue MX40 Medical Product Defect Class III Hospital
Device Correction
21/11/2018 Suction/Anticoagulation Medical Recall Class I Hospital
Assembly Lines Device
21/11/2018 UFII Control Reagent. An in vitro Medical Product Defect Class III Hospital
19/11/2018 Evidence Investigator software. Medical Product Defect Class II Retail
device (IVD).

Datei Levelvi
16/11/2018 DuraDiagnost R4 - DuraDiagnost Medical Product Defect Class III Hospital
X-ray System Device Correction
16/11/2018 Foetal Scalp Blood Sampling Kit Medical Product Defect Class I Hospital
and Foetal Scalp Blood Device Correction
Sampling Wands
16/11/2018 IMRIS ORT100 and ORT300 Medical Product Defect Class II Hospital
Operating Room Tables Device Correction
16/11/2018 PneumoClear Humidification Medical Product Defect Class II Hospital
Refill Icon Discrepancy Device Correction
16/11/2018 RayStation 3.5, 4.0, 4.5, 4.7, 5, Medical Product Defect Class II Hospital
6, 7 and 8A Device Correction
15/11/2018 Brilliance CT Systems Medical Product Defect Class II Retail
Device Correction
15/11/2018 CWP 800 (Central Water Plant) Medical Product Defect Class III Hospital
Systems and Clinic Panels Device Correction
14/11/2018 BoneScalpel and SonaStar Medical Product Defect Class II Hospital
FS1000 Ultrasonic Surgical Device Correction
Systems
14/11/2018 CombiDiagnost systems with Medical Product Defect Class II Hospital
software version 1.0.0, 1.0.1 and Device Correction
1.0.2
14/11/2018 PneumoClear Heated High-Flow Medical Recall Class II Hospital
Tube Set Device
14/11/2018 Revolution CT Systems with Medical Product Defect Class II Hospital
SmartStep Option Device Correction
14/11/2018 STACLOT LA (REF. 00600). An Medical Recall Class II Hospital
(IVD)
13/11/2018 A-dec Dental Chair A-dec 311 Medical Product Defect Class III Retail
(version A) Device Correction
13/11/2018 Dräger Fabius Anaesthesia Medical Product Defect Class I Hospital
Machines Device Correction
13/11/2018 Maintenance Solution Kit. An in Medical Product Defect Class III Hospital
(IVD)
13/11/2018 RX Daytona Plus. An in vitro Medical Product Defect Class III Hospital
12/11/2018 Various Trauma Guide Wires Medical Recall Class II Hospital
Device
9/11/2018 FG107 Intravitreal Procedure Medical Recall Class II Hospital
Pack #1 and FG110 Intravitreal Device
Procedure Pack #2A
8/11/2018 Compress Devices and Medical Product Defect Class II Hospital
Instruments Device Correction
8/11/2018 Da Vinci Si Drape and Medical Recall Class II Hospital
Disposable Accessory Kits Device

Datei Levelvi
8/11/2018 Eurotrol_HemoTrol Normal Medical Recall Class II Hospital
(Level 2) and Eurotrol_HemoTrol Device
High (Level 3). An in vitro
8/11/2018 Philips HeartStart MRx M3538A Medical Product Defect Class I Hospital
Batteries Device Correction
8/11/2018 Suboxone Film 2/0.5 Medicine Product Defect Class II Retail
buprenorphine (as hydrochloride) Alert
2mg / naloxone (as
hydrochloride dihydrate) 0.5mg
soluble film sachet
7/11/2018 Ipsogen BCR-ABL kits. An in Medical Product Defect Class II Hospital
(IVD)
6/11/2018 Cetirizine 10mg tablet blister Medicine Recall Class III Retail
packs
5/11/2018 FoodPrint Microarray 200+ Food Medical Product Defect Class II Hospital
IgG. An in vitro diagnostic Device Correction
5/11/2018 HEA Precise Type Beadchip Kit Medical Recall Class II Hospital
and RHD Beadchip Kit, CE. An Device
(IVD)
5/11/2018 Kodak DirectView DR 7500 Medical Product Defect Class II Hospital
5/11/2018 Subcutaneous Implantable Medical Hazard Alert Class I Hospital
Cardioverter Defibrillator (S-ICD) Device
systems with SQ-RX Model 1010
Pulse Generator (PG)
1/11/2018 4-Way Stopcock w/MLL, Adapter Medical Recall Class II Hospital
DBL Male and Female LL Device
1/11/2018 ARTIS zee Systems with x-ray Medical Product Defect Class II Hospital
tube cooling units Device Correction
1/11/2018 DELFIA Xpress Sample and Medical Product Defect Class III Hospital
Calibrator Racks. An in vitro Device Correction
31/10/2018 Aisys anaesthesia devices Medical Product Defect Class II Hospital
Device Correction
30/10/2018 BD MAX System with BD MAX Medical Product Defect Class II Hospital
Reader. An in vitro diagnostic Device Correction
29/10/2018 GC Fuji BULK Medical Product Defect Class III Hospital
Device Correction
26/10/2018 Parietex Composite Parastomal Medical Hazard Alert Class II Hospital
Mesh 15cm and 20cm Device
26/10/2018 Plex Elite 9000 Medical Product Defect Class II Retail
Device Correction
25/10/2018 Access hsTnI Reagent. An in- Medical Product Defect Class III Hospital
(IVD)
25/10/2018 LoFric 40cm CH12 Nelaton Medical Product Defect Class III Consumer
Catheter Device Correction

Datei Levelvi
25/10/2018 VITEK 2 AST-ST01 and AST- Medical Product Defect Class II Retail
ST03 Cards used with the VITEK Device Correction
2 Systems. An in vitro diagnostic
24/10/2018 Heater-Cooler 3T, 230V Medical Product Defect Class I Hospital
Device Correction
23/10/2018 Corneal Allograft (right and left) Biological Hazard Alert Class I Hospital
23/10/2018 Dimension Vista Intelligent Lab Medical Product Defect Class II Hospital
Systems with Software v.3.7 or Device Correction
v.3.8.1. An in vitro diagnostic
23/10/2018 Dimension Vista System utilising Medical Product Defect Class II Hospital
Lactate Dehydrogenase (LDI) Device Correction
Flex reagent cartridge. An in vitro
23/10/2018 St Jude Medical Infinity DBS Medical Hazard Alert Class II Hospital
(Deep Brain Stimulation) System Device
for the 8-Channel Lead, 0.5mm
spacing
22/10/2018 Alaris GH and CC Syringe Pump Medical Product Defect Class II Hospital
Device Correction
22/10/2018 Iridex TruFocus LIO Premiere Medical Product Defect Class II Hospital
Laser Indirect Ophthalmoscope Device Correction
22/10/2018 Multiple products containing Medical Recall for Class II Hospital
Natural Rubber Latex Device Product
Correction
22/10/2018 ZEISS Laser Based Systems Medical Product Defect Class II Hospital
Cell Observer SD, DirectFRAP, Device Correction
Laser TIRF. An in vitro
19/10/2018 CARESCAPE R860 Inspiratory Medical Product Defect Class II Hospital
Safety Guard Device Correction
19/10/2018 HeartStart FR3 Automated Medical Recall Class I Hospital
External Defibrillators Device
19/10/2018 RHD BeadChip Kit. An in vitro Medical Recall Class II Hospital
18/10/2018 CyberKnife M6 Treatment Medical Product Defect Class II Hospital
Delivery System Device Correction
Chemistry strips - An in vitro Device Correction
17/10/2018 NUCLISENS Lysis Buffer. An in Medical Recall Class II Hospital
(IVD).
17/10/2018 RX Monaco. An in vitro Medical Product Defect Class II Retail
16/10/2018 Alinity i Free T3 and Alinity i Medical Product Defect Class II Hospital
Total T3 Reagent Kits. An in vitro Device Correction

Datei Levelvi
16/10/2018 ARCHITECT Free T3 and Medical Product Defect Class II Hospital
ARCHITECT Total T3 Reagent Device Correction
Kits. An In vitro diagnostic
16/10/2018 Biograph mMR with software Medical Product Defect Class II Hospital
version syngo E11P when using Device Correction
BodyCOMPASS
16/10/2018 Giraffe OmniBed Medical Product Defect Class II Hospital
Device Correction
16/10/2018 H3 Poly Inlay Medical Recall Class II Hospital
Device
16/10/2018 Neurofolin (L-methylfolate Medicine Product Defect Class III Retail
Calcium), 15mg powder, 30 Alert
sachets
16/10/2018 Reverse T3 RIA. An in vitro Medical Product Defect Class II Hospital
15/10/2018 Evidence Analyser Operator Medical Product Defect Class II Hospital
Manual (EV3584) - An in vitro Device Correction
diagnostic medical device.
12/10/2018 Lifeshield Primary Plum Set 15 Medical Recall Class II Hospital
Micron Filter in Sight Chamber, Device
CLAVE Secondary Port, 0.2
Micron Filter, CLAVE Y-Site,
Polyethylene Lined Tubing,
Secure Lock 272cm / 23mL
12/10/2018 Radiometer AQT90FLEX Medical Product Defect Class III Hospital
Immunoassay analyser. An in Device Correction
(IVD)
12/10/2018 StrataMR Adjustment Tool Kit Medical Product Defect Class I Hospital
Device Correction
12/10/2018 TEXAS Bronchoscope Tube Medical Recall Class II Hospital
Device
12/10/2018 TITAN 3-D Wedge, Evans, Medical Recall Class II Wholesale
Large, 10mm Device
11/10/2018 Codan Filter used with Medrad Medical Recall Class II Hospital
Patient Administration Sets Device
(PAS) and Intego PET Infusion
Systems
11/10/2018 Elecsys FT4III assay. An in vitro Medical Product Defect Class III Hospital
11/10/2018 Evo Excel ECG Power Outlet Medical Product Defect Class II Hospital
Device Correction
10/10/2018 Medtronic MiniMed 640G Insulin Medical Product Defect Class II Consumer
Pumps with version 4.10 Device Correction
software
9/10/2018 All Dash 3000/4000/5000, Solar Medical Product Defect Class I Hospital
8000M/i and Solar 9500 patient Device Correction
monitors
9/10/2018 CareLink 2090 and CareLink Medical Product Defect Class I Hospital
Encore 29901/29901A Device Correction
Programmers

Datei Levelvi
9/10/2018 Multiple components of the Medical Recall Class III Hospital
DORO Lucent Headrest System Device
9/10/2018 RAPIDPoint 500 Blood Gas Medical Product Defect Class II Hospital
Systems. An in-vitro diagnostic Device Correction
8/10/2018 ARCHITECT HAVAb-IgM, Medical Recall Class II Hospital
HAVAb IgG Reagent and Alinity i Device
HAVAb IgG. An in vitro
8/10/2018 Atellica IM 1300 and 1600 Medical Product Defect Class II Hospital
Analyser, Atellica CH 930 Device Correction
Analyser and Atellica Sample
Handler Prime. An in vitro
8/10/2018 BD Nexiva Closed IV catheter Medical Recall Class II Hospital
Dual port 18GA 1.25 IN Device
8/10/2018 ColoVantage Home-Faecal Medical Product Defect Class II Retail
Immunochemical Test Kits. An in Device Alert
(IVD)
8/10/2018 DigitalDiagnost Systems with Medical Product Defect Class II Hospital
system software versions 4.1.x Device Correction
and 4.2.x
8/10/2018 EA 1490-1208-1G Dermatology Medical Recall Class III Hospital
Profile ELISA. An in vitro Device
8/10/2018 Various Giraffe and Panda Medical Product Defect Class II Hospital
OmniBed Carestations, Device Correction
Incubator Carestations and
Warmers
5/10/2018 Pruitt F3-S Polyurethane Medical Recall Class II Hospital
Outlying Carotid Shunt Device
4/10/2018 Biograph mCT and Biograph Medical Product Defect Class II Hospital
Horizon Systems Device Correction
4/10/2018 Dimension Integrated Chemistry Medical Product Defect Class II Hospital
Systems. An in vitro diagnostic Device Correction
Device
Device Correction
4/10/2018 Therakos Cellex Photopheresis Medical Product Defect Class II Hospital
4/10/2018 YUKON OCT Spinal System Medical Hazard Alert Class II Hospital
Polyaxial Screw Size 3.5 x Device
34mm
3/10/2018 Buddy Disposable Sets Medical Recall Class II Hospital
Device
3/10/2018 CUSA Excel (Excel+) Ultrasonic Medical Product Defect Class II Hospital
Surgical Aspirator System Device Correction
3/10/2018 Femoral Head Biological Hazard Alert Class III Hospital

Datei Levelvi
3/10/2018 Orthofix Drill Bits - Tin Coated - Medical Recall Class II Hospital
Quick Connect Device
2/10/2018 CARDIOSAVE Hybrid IABP Medical Product Defect Class II Hospital
Intra-Aortic Balloon Pump Device Correction
2/10/2018 LOGIQ E10 ultrasound systems Medical Product Defect Class II Hospital
(when used with TEE probes) Device Correction
2/10/2018 Puritan Bennett 980 (PB980) Medical Product Defect Class II Hospital
Ventilator Series Device Correction
28/09/2018 Femoral Head Whole, Frozen, Biological Hazard Alert Class II Hospital
Irradiated - L
28/09/2018 Robosac Espiner Medical Tissue Medical Recall Class II Hospital
Retrieval System Device
27/09/2018 O-arm O2 Imaging Systems Medical Product Defect Class II Hospital
Device Correction
26/09/2018 25GA Vitrectomy Cutter Medical Recall Class II Hospital
Device
26/09/2018 All B20/B20i/B40/B40i, and Medical Product Defect Class I Hospital
B105/B125 patient monitors Device Correction
26/09/2018 CoaguChek PT Test Systems. Medical Product Defect Class II Hospital
An in-vitro diagnostic medical Device Correction
device (IVD)
26/09/2018 HydroSet Injectable HA Bone Medical Recall Class III Hospital
Substitute 10cc Device
26/09/2018 Liquid Cardiac Controls - Medical Product Defect Class II Hospital
Troponin T. An in vitro diagnostic Device Correction
25/09/2018 Cooper Surgical Retractor Medical Recall Class II Hospital
System Elastic Stays Device
25/09/2018 X-Short anti-tip tubes on certain Medical Product Defect Class II Consumer
TiLite manual wheelchairs Device Correction
24/09/2018 AFX/AFX2 Endovascular AAA Medical Product Defect Class I Hospital
24/09/2018 Cornea (right and left) - corneal Biological Hazard Alert Class II Hospital
allograft
24/09/2018 GenesisBiosystems/LipiVage, Medical Recall Class II Hospital
Syringe & Cannula Device
(IVD)
20/09/2018 SoKINOX NO Delivery and Medical Product Defect Class II Hospital
19/09/2018 Aptio Automation System by Medical Product Defect Class II Hospital
Inpeco (Aptio2). An in-vitro Device Correction
18/09/2018 Altrix Precision Temperature Medical Product Defect Class II Hospital
Management System Device Correction
18/09/2018 Millennium MG, Millennium MC Medical Product Defect Class I Hospital
and Millennium MYOSIGHT Device Correction
18/09/2018 NET Homeopathic Remedies Medicine Recall Class II Consumer

Datei Levelvi
17/09/2018 Arjo Citadel Plus Bed Frame with Medical Product Defect Class II Hospital
Powerdrive Device Correction
17/09/2018 Dimension Vista Lipase (LIPL). Medical Product Defect Class II Hospital
device (IVD)
17/09/2018 Intravenous Cannula Insertion Medical Recall Class II Hospital
Pack Device
13/09/2018 ACCELERATOR a3600. An in- Medical Product Defect Class I Hospital
(IVD)
13/09/2018 ADVIA Chemistry Creatine Medical Recall Class II Hospital
Kinase (CK_L) System Reagent. Device
device (IVD)
13/09/2018 Biomet 360 Tibial Augment With Medical Hazard Alert Class III Hospital
Bolts Device
13/09/2018 BOND Slide Labeller Zebra Medical Recall Class II Hospital
Printer Power Supply Unit (PSU) Device
for use with BOND-lll and BOND-
MAX instruments. An in vitro
13/09/2018 Dimension Lipase (LIPL) Flex Medical Recall Class II Hospital
reagent cartridges. An in vitro Device
13/09/2018 Samsung Digital X-Ray System Medical Product Defect Class II Hospital
Device Correction
13/09/2018 VITROS 5600 Integrated System Medical Product Defect Class II Hospital
and VITROS 5600 Refurbished Device Correction
Integrated System. An in vitro
12/09/2018 AK 98 – Excessive UltraFiltration Medical Product Defect Class II Hospital
(UF) in Low-Weight Patients Device Correction
12/09/2018 Medsurge Calcitriol 1mcg/mL Medicine Recall Class II Hospital
15mL Oral Solution
11/09/2018 4020 - FSCA - FilmArray Blood Medical Product Defect Class II Hospital
Culture Identification - BCID Device Correction
Panel - An in vitro diagnostic
medical device (IVD),
10/09/2018 Soluscope AER Sprint Medical Product Defect Class II Hospital
Device Correction
7/09/2018 Femoral Head Allograft Biological Hazard Alert Class I Hospital
6/09/2018 ARCHITECT ICT Module. An in Medical Recall Class II Hospital
(IVD)
5/09/2018 Alere Triage NT-pro BNP Test. Medical Recall Class II Hospital
device (IVD)
5/09/2018 Calibration Film used with the Medical Recall Class II Hospital
Ball-Cube II phantom - Device
CyberKnife Treatment Delivery
System

Datei Levelvi
5/09/2018 CentriMag Acute Circulatory Medical Product Defect Class II Hospital
Support System Motor Device Correction
5/09/2018 VIROTROL HIV-1 Ag. An in vitro Medical Recall Class II Hospital
diagnostic medical device (IVD). Device
4/09/2018 Various Ventana Antibody and Medical Recall Class II Hospital
Detection Kit Reagents. An in Device
(IVD)
3/09/2018 Alere NT-proBNP for Medical Recall Class II Hospital
ARCHITECT Controls. An in vitro Device
Controller Device Alert
3/09/2018 MEDUMAT Transport Ventilator Medical Product Defect Class II Hospital
Device Correction
31/08/2018 D-100 Haemoglobin Testing Medical Product Defect Class II Hospital
System. An in vitro diagnostic Device Correction
31/08/2018 OVC3 36S A2 Refills Medical Recall Class III Retail
Device
31/08/2018 Philips HeartStart M5072A Medical Product Defect Class III Retail
Infant/Child SMART Pads Device Alert
Cartridge
31/08/2018 VITEK 2 System for AST An in Medical Product Defect Class II Hospital
(IVD)
30/08/2018 CyPass Micro-Stent Medical Hazard Alert Class II Hospital
Device
30/08/2018 Enzymatic Creatinine, HDL Medical Product Defect Class II Hospital
Cholesterol, Lipase, Uric Acid. Device Correction
device (IVD).
30/08/2018 Selenium Cell Defence Hard Medicine Recall Class II Retail
shell capsules
30/08/2018 Tremoflo C100 Airwave Medical Product Defect Class III Hospital
Oscillometry System Device Correction
30/08/2018 TrueBeam, TrueBeam STx, Medical Product Defect Class II Hospital
VitalBeam and EDGE treatment Device Correction
delivery systems, v2.0 and 2.5
[<2.5MR2]
28/08/2018 Jelco ViaValve safety I.V. Medical Recall Class II Hospital
catheter Device
28/08/2018 Pastorex Meningitis - reagent R4 Medical Product Defect Class II Hospital
(Streptococcus pneumoniae Device Correction
latex - green cap bottle). An in
(IVD)
27/08/2018 Femoral Head Allograft Biological Hazard Alert Class I Hospital
27/08/2018 Hoffmann Limb Reconstruction Medical Recall Class II Hospital
Frame (LRF) System Hexapod Device
Struts

Datei Levelvi
23/08/2018 Purely White Skin Brightening Medicine Recall Class III Retail
Day Cream SPF30
23/08/2018 SICKLEDEX 50-test and 12-test Medical Recall Class II Hospital
variants. An in vitro diagnostic Device
22/08/2018 Aptio Automation and Medical Product Defect Class I Hospital
StreamLAB Automation. An in Device Correction
(IVD).
22/08/2018 M300 PS, C300 PS, C350 PS, Medical Product Defect Class II Consumer
C500 PS, (PS Seating only) Device Correction
20/08/2018 AlignRT Plus/OSMS system Medical Product Defect Class II Hospital
Device Correction
20/08/2018 Broach Handles for rasp used in Medical Product Defect Class II Hospital
orthopaedic surgery Device Correction
20/08/2018 CLOPINE Suspension Clozapine Medicine Recall Class II Retail
50mg/mL
20/08/2018 Hematek Wright-Giemsa Stain Medical Recall Class II Hospital
and Modified Wright’s Stain Paks Device
/ ADVIA Autoslide Wright-
Giemsa Stain and Modified
Wright’s Stain. An in vitro
20/08/2018 MultipleVERASENSE ZBH- Medical Recall Class III Hospital
PSNCRxxxx-x devices. Device
20/08/2018 Ysio and Ysio MAX with Tube Medical Product Defect Class II Hospital
stand 3D V Device Correction
Module (SCM) software version Device Correction
2.5.0. An in vitro diagnostic
17/08/2018 Capnostream 20 and Medical Product Defect Class II Hospital
Capnostream 20p Bedside Device Correction
Patient Monitors
17/08/2018 Cerner Dosage Calculator used Medical Product Defect Class II Hospital
via PowerOrders or Pharmacy Device Correction
Medication Manager
17/08/2018 DX-D 600 Digital Radiography Medical Product Defect Class II Hospital
17/08/2018 Enterprise Imaging for Radiology Medical Product Defect Class II Hospital
Device Correction
17/08/2018 Organ Care System (OCS) Heart Medical Product Defect Class II Hospital
system - OCS Heart Console Device Correction
16/08/2018 UniCel DxH 800 and UniCel DxH Medical Product Defect Class I Hospital
600 Coulter Cellular Analysis Device Correction
16/08/2018 Xpert Xpress Flu/RSV assay. An Medical Recall Class II Hospital
(IVD)
15/08/2018 Alcon or Endure LuxOR E71 Medical Product Defect Class II Hospital
Ophthalmic Microscope Device Correction

Datei Levelvi
15/08/2018 da Vinci Xi Stapler 45 Blue and Medical Product Defect Class II Hospital
Green Reload Device Correction
15/08/2018 Olympus Bronchofiberscopes, Medical Product Defect Class II Hospital
Bronchovideoscopes, Device Correction
Bronchofibervideoscopes,
Ultrasonic
Bronchofibervideoscopes, Rhino-
laryngo Videoscopes and Airway
Mobilescopes
14/08/2018 Tools Database v1.288 CD Medical Product Defect Class II Hospital
Device Correction
13/08/2018 Mako Vizadiscs and Vizadisc Hip Medical Recall Class II Hospital
Tracking Kit Device
13/08/2018 Thermablate Endometrial Medical Product Defect Class II Hospital
Ablation System (EAS) Device Correction
10/08/2018 Nokia Blood Pressure Monitor Medical Product Defect Class II Consumer
Plus (BPM+) Device Correction
10/08/2018 Short Term Haemodialysis Medical Recall Class II Hospital
Catheters Device
10/08/2018 sterEOS Image Review Medical Product Defect Class III Hospital
Workstation Device Correction
9/08/2018 Deprox System Medical Product Defect Class III Hospital
Device Correction
9/08/2018 Femoral Head Biological Hazard Alert Class II Hospital
9/08/2018 Matrx Digital MDM Mixer Medical Product Defect Class II Retail
Device Correction
9/08/2018 Spatz3 Adjustable Gastric Medical Product Defect Class II Hospital
Balloon System Device Correction
8/08/2018 ADVIA Centaur CKMB Calibrator Medical Product Defect Class II Hospital
Kit. An in vitro diagnostic medical Device Correction
device (IVD)
8/08/2018 Bard Arctic Sun 5000 Medical Product Defect Class II Hospital
Device Correction
8/08/2018 Hoffmann LRF Hexapod Medical Product Defect Class II Hospital
Software Device Correction
8/08/2018 MOSAIQ Medical Oncology Medical Product Defect Class II Hospital
version 2.64 SP3 and higher Device Correction
8/08/2018 Various in vitro fertilisation (IVF) Medical Recall Class II Retail
and assisted reproduction Device
technologies (ART) products
7/08/2018 Bone, morsellised, frozen, Biological Hazard Alert Class II Hospital
irradiated - L
3/08/2018 Deltastream Heater-Cooler Unit Medical Product Defect Class I Hospital
Device Correction
2/08/2018 Maquet Heater-Cooler Unit HCU Medical Product Defect Class I Hospital
40 Device Correction
2/08/2018 SureSigns VS & VM Monitors Medical Product Defect Class II Hospital
Device Correction

Datei Levelvi
2/08/2018 Various Allura Xper Systems Medical Product Defect Class II Hospital
delivered with an actuator for the Device Correction
FlexVision Monitor Ceiling
Suspension between 2003 - May
2011
1/08/2018 ARTIS Q and ARTIS pheno with Medical Product Defect Class II Hospital
a specific production lot of Device Correction
Detector Cooling Units
1/08/2018 Dräger Ceiling Supply Unit; Medical Product Defect Class II Hospital
AGILA and Movita Lift Pendants Device Correction
31/07/2018 Alaris Syringe Pumps Medical Product Defect Class I Hospital
Device Correction
31/07/2018 ARCHITECT c4000, c8000, Medical Product Defect Class II Hospital
c16000 Processing Modules. An Device Correction
(IVD)
31/07/2018 ARCHITECT EBV VCA IgM Medical Product Defect Class II Hospital
Reagent Kit. An in vitro Device Correction
31/07/2018 Durex Real Feel Non Latex Medical Recall Class II Consumer
Condoms Device
30/07/2018 BIS Vista Monitoring Systems Medical Product Defect Class II Hospital
Device Correction
30/07/2018 V-PRO 1, V-PRO 1 Plus and V- Medical Product Defect Class II Hospital
PRO maX Low Temperature Device Correction
Sterilisation Systems
27/07/2018 4008 Bloodlines Medical Recall Class I Hospital
Device
27/07/2018 Corail AMT Neck Trials Surgical Medical Product Defect Class III Hospital
Instruments Device Correction
27/07/2018 The Binding Site Human IgM kit Medical Recall Class II Hospital
for use on the SPAPLUS. An in Device
(IVD).
26/07/2018 Carestation 620/650/650c A1, Medical Product Defect Class I Hospital
Carestation 620/650/650c A2, Device Correction
Carestation 30 and 9100c NXT
Anaesthesia Systems
26/07/2018 MyLab Alpha in combination with Medical Product Defect Class II Hospital
probe models IH 6-18 and IL 4- Device Correction
13
26/07/2018 PP2030 Mannitol Salt Agar Medical Recall Class II Hospital
Plates. An in vitro diagnostic Device
26/07/2018 RAPIDPoint 405 / 500 Systems Medical Product Defect Class II Hospital
and RAPIDLab 1245 / 1265 Device Correction

Datei Levelvi
25/07/2018 O-Two Equinox Relieve and Medical Product Defect Class II Hospital
Equinox Advantage Analgesic Device Correction
Gas Delivery Systems
25/07/2018 Various Vascutek Gelatin Sealed Medical Product Defect Class III Hospital
Grafts Device Correction
24/07/2018 ARCHITECT Creatine Kinase. Medical Recall Class II Hospital
device (IVD)
24/07/2018 da Vinci Xi and X Surgeon Medical Product Defect Class II Hospital
Consoles Device Correction
20/07/2018 LINEZOLID MYX linezolid 600 Medicine Recall Class I Hospital
mg/300 mL injection infusion bag
20/07/2018 Technetium-99m Makro- Medicine Recall Class I Retail
Albumon and Technitium-99m
Nanoscan
19/07/2018 IH-Com Fullversion & IH-Com for Medical Product Defect Class I Hospital
Reader. An in vitro diagnostic Device Correction
17/07/2018 CFX96-IVD Optical Reaction Medical Product Defect Class II Hospital
16/07/2018 Minicon BS15. An in vitro Medical Recall Class II Hospital
16/07/2018 Richard Wolf TEM Tube Set Medical Recall Class II Hospital
Device
13/07/2018 Atellica Solution products Medical Product Defect Class II Hospital
running on Atellica Solution Device Correction
System Software V 1.13 and
lower
12/07/2018 MAYFIELD Infinity XR2 Medical Product Defect Class II Hospital
Radiolucent Base Unit Device Correction
10/07/2018 BACT/ALERT VIRTUO System. Medical Product Defect Class II Hospital
device (IVD)
10/07/2018 NovoPen Echo Medical Recall Class II Consumer
Device
10/07/2018 Pentax Duodenoscope Medical Product Defect Class II Hospital
Device Correction
10/07/2018 RayStation and RayPlan Medical Product Defect Class I Hospital
Device Correction
9/07/2018 Charcot Osteotome Chisels Medical Recall Class II Hospital
Device
9/07/2018 cobas p 612 pre-analytical Medical Product Defect Class II Hospital
system (LCP1). An in vitro Device Correction
9/07/2018 Perifix Catheter Connector Medical Product Defect Class II Hospital
Device Correction
9/07/2018 Platinium Implantable Cardiac Medical Recall Class I Hospital
Defibrillator (ICD) and Device
Resynchronisation Therapy
Defibrillator (CRT-D)

Datei Levelvi
9/07/2018 Radiometer ABL800 blood gas Medical Product Defect Class II Hospital
analysers with software versions Device Correction
6.14 through to Version 6.18. An
(IVD).
6/07/2018 GETINGE EDS8 (Endoscope Medical Product Defect Class II Hospital
Drying and Storage Cabinet) Device Correction
Compressor
6/07/2018 Radiometer ABL800 FLEX series Medical Product Defect Class II Hospital
blood gas analysers with Crea Device Correction
module. An in vitro diagnostic
5/07/2018 5008 PAED Therapy System Medical Product Defect Class I Hospital
Device Correction
5/07/2018 Percepta CRT-P MRI SureScan Medical Hazard Alert Class I Hospital
(W1TR04) and Percepta Quad Device
CRT-P MRI SureScan (W4TR04)
5/07/2018 Premicath Neonatal PICC with Medical Product Defect Class II Hospital
Stylet Device Correction
4/07/2018 Guardian Connect Mobile App Medical Product Defect Class II Consumer
Device Correction
3/07/2018 Nutriline and Nutriline Twinflo Medical Product Defect Class II Hospital
Peripherally inserted central Device Correction
catheters (PICC)
3/07/2018 Pulmonary Conduit, Biological Hazard Alert Class I Hospital
Cryopreserved
2/07/2018 10mm 0Deg Infrared Telescope Medical Product Defect Class II Hospital
and 10mm 30Deg Infrared Device Correction
Telescope
2/07/2018 Aidacare FL250 Bed, Single and Medical Product Defect Class III Consumer
King Single Device Correction
2/07/2018 EnTrust VR/DR/AT ICDs Medical Hazard Alert Class I Hospital
Device
2/07/2018 Journey BCS Knee System - Medical Hazard Alert Class II Hospital
Femoral Components Device
2/07/2018 Leksell GammaPlan 11.1 Medical Product Defect Class II Hospital
Device Correction
2/07/2018 Patient Support Medical Product Defect Class II Retail
(NC989001087431) for X-Ray Device Correction
System
29/06/2018 CARDIOSAVE Hybrid IABP Medical Product Defect Class I Hospital
Intra-Aortic Balloon Pump Device Correction
29/06/2018 EZ1 Advanced XL instrument. Medical Product Defect Class II Hospital
device (IVD)
29/06/2018 Femoral Head Allograft - Fine Biological Hazard Alert Class II Hospital
Milled Bone
29/06/2018 VITROS Chemistry Products Medical Recall Class II Hospital
Na+ Slides. An in vitro diagnostic Device

Datei Levelvi
27/06/2018 GETINGE WD15 Claro - Washer Medical Product Defect Class II Retail
Disinfector Device Correction
27/06/2018 Natus Medical EEG Machines Medical Product Defect Class II Hospital
using Neuroworks v8.5 software Device Correction
26/06/2018 ARTIS Q, ARTIS pheno systems Medical Product Defect Class II Hospital
and X-ray generator Device Correction
26/06/2018 Chorionic Villus Biopsy Needle Medical Recall Class III Retail
Set Device
25/06/2018 Allura Xper with FlexVision large Medical Product Defect Class II Hospital
screen monitor Device Correction
25/06/2018 PhaSeal Secondary Set (C61) Medical Recall Class II Retail
Device
22/06/2018 Tritanium PL 6mm Medical Recall Class III Hospital
Device
21/06/2018 Zippie Zone Wheelchair Medical Product Defect Class II Consumer
Device Correction
20/06/2018 Allura Xper Medical Product Defect Class II Hospital
Device Correction
20/06/2018 AMBU Ultraseal II Anaesthetic Medical Recall Class II Hospital
Mask Device
20/06/2018 CARESCAPE B450, B650 and Medical Product Defect Class I Retail
B850 Monitors (Bx50) Device Correction
20/06/2018 NxStage Express Fluid Warmer Medical Product Defect Class II Hospital
Device Correction
20/06/2018 Safil Sutures Medical Recall Class II Hospital
Device
20/06/2018 Synapse Cardiovascular (CV) Medical Product Defect Class II Hospital
20/06/2018 T34 Ambulatory Syringe Pumps Medical Product Defect Class II Hospital
Device Correction
19/06/2018 Alaris Infusion pump Medical Product Defect Class II Hospital
administration sets Device Correction
19/06/2018 Discovery MR750w Medical Product Defect Class II Hospital
Device Correction
19/06/2018 Earmoulds in use with children Medical Product Defect Class II Retail
under 36 months Device Correction
19/06/2018 Mako RIO System Irrigation Clip Medical Recall Class II Hospital
(partial knee application only) Device
19/06/2018 NeoMed Enteral Feeding Tubes Medical Recall Class II Hospital
with EO Connectors Device
Device Correction
19/06/2018 Symmetry Surgical/Olsen – Medical Product Defect Class II Retail
Single Use Electrocautery Device Correction
Forceps/Pencils/Cords
19/06/2018 Visionaire Lightweight Alignment Medical Recall Class III Hospital
Rod Device

Datei Levelvi
18/06/2018 GE Healthcare MRI Systems Medical Product Defect Class II Retail
Device Correction
18/06/2018 In-Line Blood Set with Filter Medical Recall Class I Hospital
Device
18/06/2018 QuikFlap Neuro Implants Medical Recall Class II Hospital
Device
15/06/2018 Dermatome AN Medical Recall Class II Hospital
Device
15/06/2018 qUAntify Control / qUAntify Plus Medical Product Defect Class III Hospital
14/06/2018 MobileDiagnost wDR Medical Product Defect Class III Hospital
Device Correction
14/06/2018 MRSASelect II agar. An in vitro Medical Product Defect Class II Hospital
8/06/2018 Samsung Digital X-Ray System Medical Product Defect Class II Retail
GC80 Device Correction
7/06/2018 FLOSEAL Special Applicator Medical Recall Class II Hospital
Tips Device
7/06/2018 microTargeting Depth Stop Medical Recall Class II Hospital
Adapter Device
6/06/2018 Covidien Endo GIA Articulating Medical Recall Class I Hospital
Reloads with Tri-Staple Device
Technology
6/06/2018 Segmental System Proximal Medical Hazard Alert Class II Hospital
Femoral Component 38mm Device
Offset
5/06/2018 Biograph, Symbia T and Symbia Medical Product Defect Class II Retail
Intevo SPECT/CT systems Device Correction
5/06/2018 Emergency Room Examination Medical Product Defect Class II Retail
Table Device Correction
5/06/2018 M320 Microscope Systems Medical Product Defect Class II Hospital
Device Correction
5/06/2018 Philips Xper Flex Cardio Patient Medical Product Defect Class II Hospital
Monitoring Systems Device Correction
5/06/2018 StraightShot Microdebrider Medical Recall Class II Hospital
Blades Device
5/06/2018 Valpam 5mg, 50 tablets Medicine Product Defect Class II Consumer
Alert
4/06/2018 DBL METRONIDAZOLE Medicine Recall Class I Hospital
INTRAVENOUS INFUSION
metronidazole 500mg/100mL
solution for injection bag
1/06/2018 HeartMate 3 Left Ventricular Medical Hazard Alert Class I Hospital
Assist System Device
1/06/2018 HF-Resection Electrode Medical Product Defect Class III Hospital
Device Correction

Datei Levelvi
1/06/2018 N Latex CDT. An in vitro Medical Product Defect Class II Hospital
31/05/2018 ARTIS pheno systems Medical Product Defect Class II Hospital
Device Correction
31/05/2018 Endoscan Brush Purple Medical Recall Class III Hospital
Device
31/05/2018 Fortify, Fortify Assura, Quadra Medical Hazard Alert Class II Hospital
Assura, Quadra Assura MP, Device
Unify, Unify Assura, Unify
Quadra, Promote Quadra and
Ellipse ICD & CRT-D Devices
31/05/2018 Randox Liquid Assayed Specific Medical Product Defect Class II Hospital
Protein Controls. An in vitro Device Correction
31/05/2018 VOLISTA STANOP, TRIPOD, Medical Product Defect Class II Hospital
ACCESS and QUICKLOCK Light Device Correction
heads
30/05/2018 EZ1 DSP Virus Kit (48). An in Medical Recall Class II Hospital
(IVD)
30/05/2018 Infacol Wind Drops Oral Liquid Medicine Recall Class III Retail
Bottle 30mL
29/05/2018 LFIT Anatomic CoCr V40 Medical Hazard Alert Class II Hospital
Femoral Head Device
29/05/2018 MAS chemTRAK – H Level 1 Medical Product Defect Class III Hospital
29/05/2018 ZINBRYTA daclizumab 150 Medicine Recall Class I Retail
mg/mL solution for injection pre-
filled pen
24/05/2018 Conveyor unit (CV-50) of Medical Product Defect Class III Hospital
Sysmex XN-9000 automated Device Correction
haematology analysers. An in
(IVD)
24/05/2018 Paratherm Heater Cooler Unit Medical Product Defect Class I Hospital
Device Correction
24/05/2018 Radiometer ABL90 Flex blood Medical Product Defect Class I Hospital
gas analyser. An in vitro Device Correction
23/05/2018 Drager Fabius Anaesthesia Medical Product Defect Class II Hospital
Machine - Fabius Tiro Device Correction
23/05/2018 Various ZNN & M/DN Guide Medical Recall Class II Hospital
Wires Device
PHYT Slides. An in vitro Device
22/05/2018 Akron Tilt Table couches Medical Product Defect Class II Hospital
Device Correction

Datei Levelvi
22/05/2018 HexaPOD evo RT System with Medical Product Defect Class I Hospital
HexaPOD evo Module Device Correction
R30855101 - Salmonella Device
paratyphi A-H Stained
Suspension. An in vitro
21/05/2018 IntelliVue MX40 with software Medical Product Defect Class I Hospital
revisions B.05, B.06 and B.06.5X Device Correction
21/05/2018 Tapered Screw-Vent Implants Medical Recall Class II Retail
with 0.5 mm Machined Collar, Device
MTX Surface and Microgrooves
18/05/2018 Arcomed Volumed Set for Pump Medical Product Defect Class II Hospital
Type Volumed µVP 5005/7000 Device Correction
PVC and Gravity Use
18/05/2018 ARTIS pheno systems Medical Product Defect Class II Hospital
Device Correction
18/05/2018 OmniDiagnost-Eleva and Medical Product Defect Class II Retail
OmniDiagnost-Classic Device Correction
18/05/2018 Powered Wheelchairs Medical Product Defect Class III Consumer
Device Correction
17/05/2018 Askina Gel 15g Medical Recall Class II Hospital
Device
17/05/2018 da Vinci Xi EndoWrist Stapler Medical Recall Class II Hospital
Release Kit (SRK) Device
17/05/2018 Generation 1 Jasper Vektor Medical Recall Class III Retail
Device
17/05/2018 Hydrochloric Acid 6 Molar 30mL Medical Recall Class III Hospital
Containers. An in vitro diagnostic Device
17/05/2018 Liquichek Urine Chemistry Medical Recall Class II Hospital
Control Level 2 and Liquichek Device
Urine Chemistry Control MiniPak
(contains Level 2). An in vitro
17/05/2018 SAM XT Extremity Tourniquets Medical Recall Class II Retail
(SAM XT) - Military (SAM-XT M) Device
and Civilian (SAM-XT-C)
Products
16/05/2018 GE Healthcare Revolution EVO Medical Product Defect Class I Retail
& Optima CT Systems Device Correction
16/05/2018 MIA FORA NGS HLA Server and Medical Product Defect Class II Hospital
Software versions 3.0 and 3.1. Device Correction
device (IVD)
16/05/2018 Prismaflex Control Units Medical Product Defect Class II Hospital
Device Correction
16/05/2018 RayStation 6 (RayPlan 2) and Medical Product Defect Class II Hospital
RayStation 7 (RayPlan 7) Device Correction
15/05/2018 HeartWare Ventricular Assist Medical Hazard Alert Class I Hospital
System Device

Datei Levelvi
15/05/2018 Medtronic Clip Gun Magazine, Medical Recall Class I Hospital
Raney Clip Gun 5pk Device
14/05/2018 cobas MPX test. An in vitro Medical Recall Class II Hospital
14/05/2018 MIA FORA NGS FLEX 11 HLA Medical Product Defect Class III Hospital
Typing Kit. An in vitro diagnostic Device Correction
14/05/2018 RCI HA ACL Screw Medical Recall Class III Hospital
Device
9/05/2018 Arterial Cannulae and Medical Recall Class I Hospital
Customised Tubing Packs Device
including the 3/8” Vent plug
70000.8256
9/05/2018 Combur10 Test UX when Medical Product Defect Class II Hospital
measured on Urisys 1100. An in Device Correction
(IVD)
8/05/2018 ARTIS zee/Q systems with Large Medical Product Defect Class II Hospital
Display Device Correction
7/05/2018 Accu-Chek Inform II Test. An in Medical Recall Class II Hospital
(IVD)
7/05/2018 HARMONIC ACE + Shears with Medical Recall Class I Hospital
Adaptive Tissue Technology Device
3/05/2018 Covidien Endo GI Articulating Medical Recall Class I Hospital
Loading Units Device
3/05/2018 Dimension and Dimension Vista Medical Recall Class II Hospital
Gentamicin (GENT) Flex reagent Device
cartridge. An in vitro diagnostic
3/05/2018 O-Two Equinox Relieve and Medical Product Defect Class II Hospital
Equinox Advantage Analgesic Device Correction
Gas Delivery Systems
2/05/2018 Arcomed Volumed µVP7000 Medical Product Defect Class II Hospital
Infusion Pump Device Correction
2/05/2018 HeartStart FRx, HeartStart Medical Product Defect Class I Retail
Home, and Heartstart OnSite Device Correction
2/05/2018 Horse Blood Agar. An in vitro Medical Recall Class III Hospital
2/05/2018 OXOID AST DISC CT0159B – Medical Recall Class II Hospital
Oxacillin OX1. An in vitro Device
1/05/2018 Dräger Carina Ventilator Medical Product Defect Class I Hospital
Device Correction
1/05/2018 SOMATOM go.Up and Medical Product Defect Class II Retail
SOMATOM go.Now Device Correction
1/05/2018 Vivid and LOGIQ Ultrasound Medical Product Defect Class II Retail

Datei Levelvi
30/04/2018 The ARROWg+ard Blue PLUS Medical Recall Class II Hospital
antimicrobial catheter Device
27/04/2018 CLARUS 500 with Software Medical Product Defect Class II Retail
versions: 1.0.0, 1.0.1 and 1.0.2 Device Correction
27/04/2018 Taylor Spatial Frame Medical Recall Class III Hospital
Identification Band Kit Device
27/04/2018 Visera Elite II Video System Medical Product Defect Class III Hospital
Device Correction
26/04/2018 Nitinol Staples Medical Recall Class II Wholesale
Device
24/04/2018 DiaClon ABO/D+ Reverse Medical Product Defect Class III Hospital
Grouping for Patients. An in vitro Device Correction
24/04/2018 Dräger Jaundice Meters Medical Product Defect Class II Hospital
Device Correction
24/04/2018 Halyard Closed Suction Kits with Medical Product Defect Class I Hospital
Flex Connector Device Alert
24/04/2018 Medicina Nasogastric Tubes Medical Product Defect Class II Hospital
Device Correction
24/04/2018 OrthoScan Mini C-Arm X-Ray Medical Product Defect Class II Hospital
24/04/2018 Portex Thoracic Catheter and Medical Recall Class II Hospital
Connecting Tube Device
23/04/2018 Aequalis Humeral Nail Drill Bit Medical Recall Class II Wholesale
Device
23/04/2018 Alere Afinion ACR Control. An in Medical Recall Class II Hospital
(IVD)
23/04/2018 FUJIFILM General X-ray System Medical Product Defect Class II Hospital
FDR Smart f series Device Correction
23/04/2018 MultiDiagnost Eleva and Medical Product Defect Class II Hospital
MultiDiagnost Eleva with Flat Device Correction
Detector
23/04/2018 Philips Intera 0.5T/1.0T/ 1.5T, Medical Product Defect Class I Hospital
Achieva 1.5T, Multiva 1.5T and Device Correction
Ingenia CX 1.5T
20/04/2018 Covidien EEA Haemorrhoid and Medical Recall Class II Hospital
Prolapse Stapler Set with DST Device
Series Technology - 3.5mm
staple and 4.8mm staple devices
20/04/2018 ID-Cards for Indirect Antiglobulin Medical Product Defect Class II Hospital
Testing associated with Reagent Device Correction
Red Blood Cells. An in vitro
20/04/2018 Scalpel in Lifemed Procedure Medical Product Defect Class II Hospital
Packs Device Correction
20/04/2018 Trumpf Table Top Spinal System Medical Product Defect Class II Hospital
(T3SYSTEM) Device Correction
19/04/2018 FDGEN fludeoxyglucose [18F] Medicine Product Defect Class II Hospital
injection vial

Datei Levelvi
19/04/2018 FilmArray Blood Culture Medical Product Defect Class II Hospital
Identification (BCID) Panel when Device Correction
used with BD BACTEC Blood
Culture Bottles. An in vitro
19/04/2018 Instructions For Use (IFU) - Medical Product Defect Class II Hospital
Sonopet Ultrasonic Products Device Correction
18/04/2018 Classic Series Reusable Active Medical Recall Class II Hospital
Cord Device
18/04/2018 Sciatic Nerve Retractors Medical Recall Class II Hospital
Device
16/04/2018 Monoclonal Mouse Anti-Human Medical Recall Class II Hospital
Leukaemia, Hairy Cell Clone Device
DBA.44. An in vitro diagnostic
medical device.
13/04/2018 ADVIA 120/2120/2120i Medical Recall Class II Hospital
Haematology Systems DIFF Device
TIMEPAC Perox 1 Reagent. An
(IVD)
13/04/2018 Corneoscleral Button Biological Hazard Alert Class II Hospital
13/04/2018 Discovery IGS 730 Medical Product Defect Class II Hospital
Device Correction
13/04/2018 Fischer Cone Biopsy Excisor Medical Recall Class III Hospital
Device
13/04/2018 Radiometer TCM5 FLEX/ BASIC Medical Product Defect Class I Hospital
Transcutaneous Monitor Device Correction
13/04/2018 Radiometer TCM5FLEX/BASIC Medical Product Defect Class III Hospital
Device Correction
12/04/2018 IntraClude Intra-aortic Occlusion Medical Product Defect Class I Hospital
Device Device Alert
12/04/2018 Philips Ingenuity Core (728321) Medical Product Defect Class II Hospital
Device Correction
11/04/2018 EliA Intrinsic Factor Well. An in Medical Recall Class II Hospital
(IVD)
11/04/2018 Pulmonary Conduit, Biological Hazard Alert Class II Hospital
Cryopreserved
10/04/2018 Hudson RCI One-Way Valve Medical Recall Class I Hospital
with Capped Monitoring Port Device
9/04/2018 Power-LOAD (Cot Fastener) Medical Product Defect Class II Hospital
Device Correction
6/04/2018 ADVIA Chemistry Systems - Medical Recall Class II Hospital
Urea Nitrogen (UN). An in vitro Device
6/04/2018 G5 Mobile Receiver Medical Recall Class II Retail
Device
6/04/2018 Pulmonary Valve, Cryopreserved Biological Hazard Alert Class II Hospital

Datei Levelvi
5/04/2018 5mm ENDOPATH XCEL Trocars Medical Recall Class II Hospital
with Optiview Technology Device
4/04/2018 Cobas e 801 Analytical Unit. An Medical Product Defect Class II Hospital
(IVD)
4/04/2018 Immucor MATCH IT! DNA Medical Product Defect Class III Hospital
Software version 3.29.0 Device Correction
(released 30 Jan 2018) for use
with Allele Database used with
LIFECODES HLA-B SSO Typing
Kits. In vitro diagnostic medical
devices.
3/04/2018 Mako Onlay Insert Extractor (part Medical Recall Class II Hospital
of the Restoris MCK (Multi Device
Compartmental Knee)
Unicondylar System)
3/04/2018 OXOID AST DISC CT1412B – Medical Recall Class II Hospital
Cefpirome CPO30ug 5x 50 Device
discs. An in vitro diagnostic
medical device.
29/03/2018 F & P SleepStyle CPAP Device Medical Product Defect Class III Retail
Device Correction
29/03/2018 Randox Lipase Reagents for use Medical Product Defect Class II Hospital
on RX instruments. An in vitro Device Correction
28/03/2018 4008 HD Bloodlines Medical Product Defect Class I Hospital
Device Alert
28/03/2018 RPK-01 Luer Connector Medical Recall Class I Hospital
Device
28/03/2018 Spot Vision Screener 100 with Medical Product Defect Class II Hospital
software version up to and Device Correction
including 3.0.01.07
28/03/2018 StoneBreaker Pneumatic Medical Recall Class I Hospital
Lithotripter and associated Device
accessories
27/03/2018 Cornea (left and right) Biological Hazard Alert Class II Hospital
27/03/2018 Dimension Vista CTNI Sample Medical Recall Class II Hospital
Diluent and Multi 2 Sample Device
Diluent. An in vitro diagnostic
27/03/2018 Getinge VOLISTA StandOP and Medical Product Defect Class II Hospital
TRIPOD surgical lights Device Correction

Datei Levelvi
27/03/2018 PTS Panels CHOL+GLU test Medical Recall Class II Hospital
strips. An in vitro diagnostic Device
27/03/2018 Pulmonary Conduit Patch Biological Hazard Alert Class II Hospital
27/03/2018 Sun Specialist SPF40 High Medicine Recall Class III Retail
Protection Cream
27/03/2018 Ultrafilter U9000 for use with Medical Product Defect Class I Hospital
AK96 and AK98 v1 dialysis Device Correction
machines
26/03/2018 ACUSON SC2000 ultrasound Medical Product Defect Class II Hospital
with 5.0 software (VB20A, Device Correction
VB20B, or VB20C) and the ECG
(physio) hardware and Auxiliary
(AUX IN/OUT) cable
26/03/2018 Cornea (left and right) Biological Hazard Alert Class II Hospital
26/03/2018 Entroy Pool Lifter Medical Product Defect Class II Retail
Device Correction
26/03/2018 Infinity MCable Mainstream Medical Product Defect Class II Hospital
Sensor, Revision 16 only (used Device Correction
with Acute Care System (IACS)
Monitoring Solution; and the
Infinity M540 Stand-Alone
Patient Monitor)
26/03/2018 NAT Testing for ocular, Biological Hazard Alert Class II Hospital
musculoskeletal and skin grafts
22/03/2018 iQ200 Series Urine Microscopy Medical Product Defect Class I Hospital
Analysers Device Correction
22/03/2018 Zoledronic Acid Medicine Recall for Class II Hospital
Product
Correction
21/03/2018 Getinge Steriliser Medical Product Defect Class II Hospital
Device Correction
21/03/2018 IH-1000 with software version Medical Product Defect Class I Hospital
21/03/2018 Penumbra System Aspiration Medical Product Defect Class III Hospital
Pump - Pump Max, PMX220 Device Correction
21/03/2018 Universal Arm Support Medical Product Defect Class II Hospital
Device Correction
20/03/2018 Covidien LigaSure Exact Medical Recall Class II Hospital
Dissector Nano-Coated 20.6mm- Device
21cm
20/03/2018 NON REBREATHE MASK Medical Recall Class II Hospital
Device
Neisseria meningitidis Poly A-D Device
2mL and Neisseria meningitidis
Group D 2mL. An in vitro

Datei Levelvi
19/03/2018 HemoCue WBC Diff analysers Medical Product Defect Class II Hospital
and WBC Diff Microcuvettes. An Device Correction
(IVD)
15/03/2018 Ingenuity TF PET/CT System Medical Product Defect Class II Hospital
with Addonics Mass Storage Device Correction
Device (MSD)
15/03/2018 Pine O Cleen Disinfectant Medical Recall Class II Retail
Device
14/03/2018 EBI OsteoGen Implantable Bone Medical Hazard Alert Class II Hospital
Growth Stimulator Device
14/03/2018 Labetalol Hydrochloride Injection Medicine Recall Class I Hospital
14/03/2018 OM040R - Doyen-Collin Mouth Medical Product Defect Class III Retail
Gag 120mm Device Correction
14/03/2018 Philips CT couches used on Medical Product Defect Class II Hospital
Brilliance CT Big Bore, Brilliance Device Correction
CT Big Bore Oncology, Brilliance
iCT, Brilliance iCT SP, Ingenuity
Core, Ingenuity Core128,
Ingenuity CT, Ingenuity Flex
systems
13/03/2018 3M Surgical Clipper Medical Product Defect Class II Hospital
Device Correction
13/03/2018 ADT1018 and ADT1018-50 Flow Medical Recall Class I Hospital
QC Tubing – haemodialysis Device
blood tubing Set
13/03/2018 Capio Suture Capturing Devices Medical Product Defect Class II Hospital
(SLIM, Standard, Open Access, Device Correction
RP)
13/03/2018 da Vinci X Patient Side Cart Arm Medical Product Defect Class II Hospital
Controller Joint Circuit Boards Device Correction
13/03/2018 Drager Infinity Acute Care Medical Product Defect Class I Hospital
System (IACS) Monitoring Device Correction
Solution with s/w VG2.2 to
VG6.0 & the Infinity M540 Stand-
Alone Patient Monitor s/w from
VG2.2 to VG6.0
13/03/2018 Haemoband PLUS Medical Product Defect Class III Hospital
Device Correction
13/03/2018 Labetalol Hydrochloride Injection Medicine Recall Class I Hospital
9/03/2018 Servo Ventilators Medical Product Defect Class I Hospital
Device Correction
8/03/2018 Versate Monofilament Mesh, Medical Product Defect Class II Hospital
50x50 cm Device Correction
6/03/2018 Lynparza (olaparib) capsules Medicine Recall Class III Retail
50mg
6/03/2018 Rite Aid Mini Digital Temple Medical Recall Class I Consumer
Touch Thermometer Device

Datei Levelvi
5/03/2018 HACTIV Calcar reamers Medical Recall Class II Hospital
Device
2/03/2018 MindFrame Capture LP Medical Recall Class I Hospital
Device
28/02/2018 Arjo Quick Connect Scale used Medical Product Defect Class II Consumer
with Maxi Sky 2 Device Correction
27/02/2018 Dräger Fabius Anaesthesia Medical Product Defect Class I Hospital
Machines Device Alert
27/02/2018 ED-530TK Duodenoscope Medical Product Defect Class I Hospital
Device Correction
27/02/2018 Natus NicoletOne 32Ch Medical Product Defect Class II Hospital
Ambulatory EEG Record System Device Correction
27/02/2018 Siemens Somatom Emotion, Medical Product Defect Class II Hospital
Sensation, Perspective & Scope Device Correction
CT Systems with s/w versions
VB42B, VC10A, VC20A, VC20B,
VC28A, VC30A, VC30B &
VC40A
27/02/2018 SureSigns VSi, VS2+ products Medical Product Defect Class III Hospital
Device Correction
26/02/2018 Cook Aspiration Unit Medical Product Defect Class II Retail
Device Correction
26/02/2018 Injection Pipette Medical Recall Class III Retail
Device
26/02/2018 Triathlon TS Tibial Augments Medical Hazard Alert Class II Hospital
Sizes 3 and 6 Device
23/02/2018 Kaisers KAGS1800 bandage Medical Recall Class III Hospital
scissor Device
23/02/2018 Medfusion Syringe Pump Model Medical Product Defect Class I Hospital
Series 3500 Device Correction
23/02/2018 RayStation and RayPlan Medical Product Defect Class I Hospital
Device Correction
23/02/2018 Sorg Jump Alpha, Jump Beta Medical Product Defect Class II Consumer
and Vector Wheelchairs Device Correction
23/02/2018 U-100 Insulin Syringe 0.5mL Medical Recall Class II Hospital
27G and 29G Device
23/02/2018 Use of Tristel Trio Wipes System Medical Product Defect Class II Hospital
with GE TEE probe Device Correction
21/02/2018 Enterprise 8000 Electrical Bed Medical Product Defect Class III Consumer
Device Correction
21/02/2018 Invivo DynaCAD Breast and Medical Product Defect Class II Hospital
Prostate with software versions Device Correction
3.4 and 3.5
21/02/2018 LUCAS 2 Chest Compression Medical Product Defect Class I Hospital
20/02/2018 ACM W/FEM NOZZLE/PRESS Medical Recall Class II Hospital
(PK6) and INRPLS HP W/HIGH Device
FLOW TIP

Datei Levelvi
20/02/2018 ARGENE Adenovirus R-gene Medical Product Defect Class III Hospital
and Parechovirus R- Gene Device Alert
Control Kits. An in vitro
20/02/2018 Faulding Vitamin B12 Medicine Recall Class III Wholesale
19/02/2018 AQUIOS CL Flow Cytometry Medical Product Defect Class I Hospital
System. An in vitro medical Device Correction
device.
19/02/2018 Futuro Quick Strap Ankle Medical Recall Class II Retail
Support Device
19/02/2018 Single Use Instruments including Medical Product Defect Class III Hospital
Scissors, Forceps, and Suckers Device Correction
14/02/2018 balanSys UNI convex PE inlay Medical Hazard Alert Class II Hospital
x/6, x/7, x/9 Device
14/02/2018 BIOCAL Temperature Controller Medical Recall Class I Hospital
Device
14/02/2018 HeartStart MRx and FR3 Medical Product Defect Class II Hospital
Device Correction
13/02/2018 Automated 2500 Family Systems Medical Product Defect Class III Hospital
Device Correction
13/02/2018 Elements Obturation Unit with Medical Product Defect Class I Retail
Buchanan Heat Pluggers Device Correction
13/02/2018 VIDAS and mini VIDAS systems. Medical Product Defect Class II Hospital
device (IVD)
12/02/2018 CareFusion Vyntus Body with Medical Product Defect Class II Hospital
Option Diffusion Device Correction
12/02/2018 Enterprise and Citadel Range Medical Product Defect Class II Consumer
Beds Device Correction
12/02/2018 ExacTrac Patient Positioning Medical Product Defect Class II Hospital
System with software versions Device Correction
6.0, 6.1, 6.2, 6.5
12/02/2018 Hypothermia Caps, Mittens and Medical Recall Class II Hospital
Slippers Device
12/02/2018 Indigo carmine - Oral Solution - Medicine Product Defect Class II Hospital
20mg/5ml Correction
12/02/2018 ProGrade Rel.1x Systems Medical Product Defect Class III Hospital
Device Correction
12/02/2018 TRUST FENMOL paracetamol Medicine Recall Class III Retail
500mg ibuprofen 200mg tablet
blister pack
8/02/2018 Biograph Horizon with VJ20A Medical Product Defect Class II Hospital
7/02/2018 Cortisol Saliva ELISA. An in vitro Medical Recall Class II Hospital
7/02/2018 Foetal Haemoglobin Monoclonal Medical Recall Class II Hospital
Antibody (HBF-1), FITC. An in Device
(IVD)

Datei Levelvi
7/02/2018 Maquet PowerLED, HLED 700 Medical Product Defect Class II Hospital
SF and Volista 600SF Surgical Device Correction
Lighting Systems
7/02/2018 Small Pedicle Probe ELL-IN 02 Medical Recall Class II Wholesale
23-N Device
7/02/2018 syngo Workflow MLR Medical Product Defect Class II Hospital
Device Correction
7/02/2018 Zenith Branch Iliac Endovascular Medical Product Defect Class III Hospital
Graft (ZBIS) - Patient Card Device Correction
6/02/2018 3M Bair Hugger Full Access Medical Recall Class II Hospital
Underbody Blanket Device
6/02/2018 ACUSON SC2000 ultrasound Medical Product Defect Class I Hospital
systems with software versions Device Correction
VB10A, VB10B, VB10D, VB10E
that have PRIME and eSie PISA
software licenses
6/02/2018 Automate 2550 and 1250 Medical Product Defect Class I Hospital
Aliquotter Tip Present Sensor. Device Correction
device (IVD)
6/02/2018 Biograph mMR with software Medical Product Defect Class II Hospital
version syngo E11P Device Correction
5/02/2018 Dimension Vista Calcium (CA) Medical Recall Class II Hospital
Flex reagent cartridge. An in vitro Device
5/02/2018 Mako RIO System Ethernet to Medical Product Defect Class III Hospital
Fiber Optic Converter Device Correction
5/02/2018 Radiometer TCM5 FLEX / Medical Product Defect Class I Hospital
BASIC Transcutaneous Monitor Device Correction
5/02/2018 Signature Ceramic Femoral Medical Recall Class II Wholesale
Head Device
5/02/2018 Unomedical ConvaTec Frazier Medical Product Defect Class II Hospital
Suction Handle (included in Foot Device Alert
Pack Health and Lower
Extremity Procedure Packs)
2/02/2018 Phadia AB Product EliA anti- Medical Recall Class III Hospital
TSH-R Well. An in vitro Device
2/02/2018 Valleylab FT10 energy platform Medical Recall for Class II Hospital
Device Product
Correction
1/02/2018 Biatain Ag Cavity Filler Medical Recall Class II Wholesale
Device
31/01/2018 O-Arm 1000 Imaging System Medical Product Defect Class II Hospital
(3rd Edition) Device Correction
30/01/2018 Brilliance Big Bore Oncology CT, Medical Product Defect Class I Hospital
Brilliance Big Bore Radiology CT Device Correction
with software version 4.2.0

Datei Levelvi
30/01/2018 Custom Made Implant Systems Medical Hazard Alert Class II Hospital
with Minimally Invasive Grower Device
(MIG) component
30/01/2018 ETEST Polymyxin B (PO1024) Medical Product Defect Class I Hospital
blister packaging. An in vitro Device Correction
29/01/2018 Double Row Footplates, TL-HEX Medical Recall Class II Hospital
Sterile Device
29/01/2018 SwishTapered Implant 4.1mmD Medical Recall Class II Retail
x12mmL SBM Dual Blast; Device
4.8mmD Platform
25/01/2018 BD Phoenix Gram Negative Medical Product Defect Class II Hospital
Panels containing colistin. Device Correction
25/01/2018 RCI HA ACL Screw Medical Recall Class III Hospital
Device
24/01/2018 Frazier suction handle Medical Product Defect Class II Hospital
Device Alert
24/01/2018 TruVidia Wireless Receiver Medical Product Defect Class II Hospital
Device Correction
22/01/2018 ADVIA Centaur Cyclosporine, Medical Product Defect Class II Hospital
DHEA-SO4, Folate and HBc IgM Device Correction
Assays. An in vitro diagnostic
22/01/2018 Calmurid Cream tube 100g Medicine Recall Class III Wholesale
22/01/2018 therascreen PyroMark Gold Q24 Medical Recall Class II Hospital
Reagents and Pyro Buffers. An Device
(IVD)
19/01/2018 Allura Xper Systems with an Medical Product Defect Class II Hospital
attached 7th or 8th monitor Device Correction
19/01/2018 APO-METFORMIN XR 1000 Medicine Recall Class II Consumer
metformin hydrochloride 1000
mg modified release tablet blister
pack 60 tablets
19/01/2018 Artis One in conjunction with Medical Product Defect Class II Hospital
table Device Correction
18/01/2018 ADVIA Centaur CP, XP, and Medical Product Defect Class II Hospital
XPT Systems with use of BNP Device Correction
and TSH3-Ultra
18/01/2018 Panther and Panther Fusion Medical Product Defect Class II Hospital
Systems with 19-in monitor Device Correction
17/01/2018 Moog Infusion System Medical Recall Class I Hospital
Administration Sets Device
16/01/2018 AFFINITY NT Cardiotomy Medical Recall Class II Hospital
Venous Reservoirs stand-alone Device
uncoated and coated models.
16/01/2018 BVM (Bag-Valve-Mask) Manual Medical Recall Class I Hospital
Resuscitation Systems Device

Datei Levelvi
16/01/2018 FC 500 Series Flow Cytometers Medical Product Defect Class II Hospital
(new, reconditioned or Device Correction
refurbished). An in vitro
16/01/2018 LiNA Gold Loop Medical Recall Class II Sponsor
Device
16/01/2018 MAQUET VOLISTA central Medical Product Defect Class II Hospital
handle on StanOP, TRIPOD and Device Correction
ACCESS Cupolas
16/01/2018 Vacuette Minicollect Complete Medical Recall Class II Hospital
1ml Sodium Citrate 3.2%. An in Device
vitro diagnostic medical device.
16/01/2018 VIRAZOLE (Ribavirin Solution Medicine Recall Class I Hospital
for Injection 0.1g/mL), 5 x 12 mL
vials
16/01/2018 W & H Foot Control - S-N1/S-N2 Medical Recall Class II Retail
Device
15/01/2018 BrightView, BrightView X, Medical Product Defect Class II Hospital
BrightView XCT, Precedence 6, Device Correction
Precedence 16
15/01/2018 Vadi Heater Medical Recall Class II Hospital
Device
12/01/2018 CARESCAPE Central Station Medical Recall for Class I Hospital
(CSCS) software version 2.0.2 Device Product
Correction
12/01/2018 Hematoxylin II and Horseradish Medical Recall Class II Hospital
Peroxidase Reagents - An in Device
vitro medical diagnostic device
(IVD)
12/01/2018 Radiolucent Spine Surgery Medical Recall for Class II Hospital
Frame Device Product
Correction
12/01/2018 Runyes Autoclave Medical Recall for Class II Retail
Device Product
Correction
12/01/2018 Xpert HIV-l Viral Load. An in vitro Medical Recall for Class III Hospital
diagnostic medical device (IVD) Device Product
Correction
11/01/2018 Nellix EndoVascular Aneurysm Medical Recall for Class I Hospital
Sealing System Device Product
Correction
10/01/2018 NAJA Spinal Ligament Systems Medical Recall Class II Hospital
for Spinal Stabilisation Device
9/01/2018 Phadia ImmunoCAP Allergen c5, Medical Recall Class II Hospital
Ampicilloyl and ImmunoCAP Device
Allergen c6, Amoxicilloyl
9/01/2018 SIGMA HP PFJ Cemented Medical Hazard Alert Class II Hospital
Trochlear Implants Device
5/01/2018 DBL METRONIDAZOLE Medicine Recall Class II Hospital
INTRAVENOUS INFUSION
metronidazole 500mg/100mL
solution for injection bag

Datei Levelvi
5/01/2018 Philips IntelliVue Information Medical Recall for Class II Hospital
Center (PIIC) iX Device Product
Correction
5/01/2018 Salter Labs Oxygen Cannulas Medical Recall Class II Hospital
Device
4/01/2018 da Vinci Xi Surgical System P6b Medical Recall for Class III Hospital
Software Device Product
Correction
4/01/2018 Synchron Enzyme Validator. An Medical Recall for Class II Hospital
in vitro diagnostic medical device Device Product
(IVD). Correction
4/01/2018 Tibial Implants Medical Recall Class II Hospital
Device
22/12/2017 ClearSight Heart Reference Medical Recall Class II Hospital
Sensor Device
22/12/2017 DuraClone B27 Reagent Kit - an Medical Recall Class II Hospital
(IVD)
22/12/2017 Haemoglobin A1c (HbA1c) Medical Recall for Class II Hospital
Reagent. An in vitro medical Device Product
device. Correction
22/12/2017 Lifepak 20e Defibrillator/Monitor Medical Recall for Class II Hospital
Device Product
Correction
22/12/2017 Prelude SNAP Splittable Sheath Medical Recall Class II Hospital
Introducer Device
22/12/2017 SynchroMed II Implantable Drug Medical Recall for Class II Hospital
Infusion Pump Device Product
Correction
21/12/2017 Ingenuity TF PET/CT running Medical Recall for Class II Hospital
software version 4.0.2 Device Product
(4.0.0.26645) Correction
21/12/2017 Restorelle DirectFix Anterior, Medical Recall Class I Hospital
Restorelle DirectFix Posterior Device
and Altis Single Incision Sling
20/12/2017 DePuy Synthes Confidence Kit Medical Recall Class II Hospital
Spinal Cement System Device
20/12/2017 Ready-Prep %CDT by HPLC Medical Recall for Class III Hospital
using the CDM software version Device Product
MVC133091. An in vitro Correction
20/12/2017 Valitude CRT-P, Resonate, Medical Recall for Class I Hospital
Momentum & Autogen CRT-Ds, Device Product
Visionist CRT-P & Dynagen Correction
CRT-D
20/12/2017 Valitude CRT-P, Visionist CRT- Medical Hazard Alert Class I Hospital
P, Accolade Pacemakers and Device
Proponent Pacemakers
19/12/2017 CARBAGLU carglumic acid 200 Medicine Recall for Class III Hospital
mg dispersible tablets tube Product
Correction

Datei Levelvi
19/12/2017 CARESCAPE R860 ventilators Medical Recall for Class I Hospital
with software version 10SP05 Device Product
Correction
19/12/2017 CELL-DYN Emerald 22 Analyser Medical Recall for Class III Hospital
with software version v3.0.0. An Device Product
in vitro diagnostic medical device Correction
(IVD)
19/12/2017 ETEST Teicoplanin 256 (TP) Medical Recall for Class II Hospital
SPB and Foam packaging. An in Device Product
vitro diagnostic medical device Correction
(IVD)
19/12/2017 Flexible Uretero-Reno Medical Recall Class II Hospital
Videoscope & Flexible Uretero- Device
Reno Fiberscope
19/12/2017 Medtronic Clip Gun Scalp Clip Medical Recall Class I Hospital
System Device
19/12/2017 PEDEA ibuprofen 10 mg/2 mL Medicine Recall for Class III Hospital
solution for intravenous infusion Product
2 mL glass ampoule Correction
19/12/2017 Philips Intellivue Patient Monitor Medical Recall for Class II Hospital
X3 Device Product
Correction
19/12/2017 Signia Power Handle Medical Recall for Class II Hospital
Device Product
Correction
19/12/2017 SynCardia Freedom Driver Medical Recall for Class II Hospital
System (a component of the Device Product
SynCardia temporary Total Correction
Artificial Heart System)
18/12/2017 Architect c4000, c8000, c16000 Medical Recall for Class I Hospital
Cuvette Segment. An in vitro Device Product
diagnostic medical device (IVD) Correction
18/12/2017 ARCHITECT DHEA-S Reagents. Medical Recall for Class II Hospital
An in vitro diagnostic medical Device Product
device (IVD) Correction
18/12/2017 Equinox Advantage Medical Recall for Class II Hospital
Device Product
Correction
18/12/2017 IMMULITE/IMMULITE 1000 Medical Recall for Class II Hospital
IMMULITE 2000/IMMULITE Device Product
2000 XPi Assays. An in vitro Correction
18/12/2017 Nv Guider Catheter 90cm Medical Recall Class II Hospital
Device
18/12/2017 Rotating IV Pole, used with Medical Recall for Class II Hospital
Giraffe OmniBed Carestation, Device Product
Giraffe Incubator Carestation Correction
Giraffe OmniBed, Giraffe
Warmer, Panda Warmer, Giraffe
Incubator, Care Plus Incubator,
IWS, and Giraffe Shuttle.
15/12/2017 Uphold LITE with Capio SLIM Medical Recall Class I Hospital
and Solyx Single Incision Sling Device
System

Datei Levelvi
14/12/2017 Artis systems with Artis tables Medical Recall for Class II Hospital
Device Product
Correction
14/12/2017 Vacuette Minicollect Complete Medical Recall Class II Hospital
1mL Sodium Citrate 3.2%. Device
13/12/2017 C- Series lifts Medical Recall Class II Consumer
Device
13/12/2017 Transseptal Needle Medical Recall Class I Hospital
Device
12/12/2017 MCK Tibial Baseplate-RM/LL-SZ Medical Recall Class II Hospital
2 and MCK Tibial Baseplate- Device
RM/LL-SZ 7
12/12/2017 Spaplus Weekly wash Protocol Medical Recall Class III Hospital
and Bottles. An in vitro Device
12/12/2017 Volcano Imaging Systems and Medical Recall for Class II Hospital
Core Mobile Imaging Systems Device Product
Correction
12/12/2017 Volcano s5i, CORE, CORE Medical Recall for Class II Hospital
Mobile Systems with software Device Product
version V3.5 Correction
11/12/2017 C-Series Lifts Medical Recall Class II Consumer
Device
11/12/2017 Malecot Nephrostomy Catheter Medical Recall Class I Hospital
Set Device
11/12/2017 TomoTherapy High Performance Medical Recall for Class II Hospital
Patient Couch Device Product
Correction
8/12/2017 Hercules Patient Lifter Medical Recall for Class II Consumer
Device Product
Correction
8/12/2017 Pipet Tips used with AutoDG Medical Recall for Class III Hospital
System. An in vitro diagnostic Device Product
medical device Correction
6/12/2017 AQUIOS CL Flow Cytometry Medical Recall for Class II Hospital
System, software versions 2.0, Device Product
2.0.1, 2.1. An in vitro diagnostic Correction
6/12/2017 MIA FORA NGS HLA FLEX 11 Medical Recall Class II Hospital
KIT (24 tests). An in vitro Device
6/12/2017 Monoclonal Mouse Anti-Human Medical Recall Class II Hospital
CDX2, Clone DAK-CDX2. An in Device
(IVD)
5/12/2017 Airsep Impulse Elite Oxygen Medical Recall Class II Hospital
Conserving Device Device
5/12/2017 Apex Knee System Medical Recall Class III Hospital
Device
5/12/2017 Intro-Flex Automatic Hemostasis Medical Recall Class II Hospital
Valve Introducer Device

Datei Levelvi
4/12/2017 Balt Cristal Balloons Medical Recall Class I Hospital
Device
4/12/2017 Brainlab Navigation System Medical Recall Class I Hospital
Spine & Trauma 3D Device
4/12/2017 Brilliance iCT (Model 728306), Medical Recall for Class III Hospital
Brilliance iCT SP (Model Device Product
728311) and IQon Spectral CT Correction
(Model 728332) Scanner
systems
4/12/2017 Digital Accelerators with iViewGT Medical Recall for Class I Hospital
or XVI Device Product
Correction
4/12/2017 Phadia Prime with software up to Medical Recall for Class II Hospital
and including version 2.1.4 . An Device Product
in vitro diagnostic device (IVD) Correction
30/11/2017 PRICELINE PHARMACY Medicine Recall Class III Retail
PERIOD PAIN RELIEF naproxen
sodium 275mg tablet blister pack
29/11/2017 Cordis S.M.A.R.T. Flex Vascular Medical Recall Class II Hospital
Stent System Device
29/11/2017 Various Vital-Port Vascular Medical Recall Class I Hospital
Access Systems Device
27/11/2017 BiPAP A 40 Ventilatory Support Medical Recall for Class III Hospital
System Device Product
Correction
27/11/2017 CADD Legacy 1, Model 6400 Medical Recall for Class III Hospital
Ambulatory Infusion Pump Device Product
Correction
27/11/2017 IntelePACS with software Medical Recall for Class II Hospital
versions 4-3-1 and up Device Product
Correction
27/11/2017 Thermo Scientific Remel Shigella Medical Recall Class II Hospital
sonnei (Phases 1& 2) Device
Agglutinating Serum. An in vitro
24/11/2017 Allen Medical Bow Frame Medical Recall for Class II Hospital
Device Product
Correction
23/11/2017 RayStation and RayPlan Medical Recall for Class II Hospital
Device Product
Correction
23/11/2017 RE51021 / MuSK-Ab ELISA Medical Recall Class III Hospital
Device
23/11/2017 SURGICAL GOWN UL HP L Medical Recall Class II Hospital
Device
22/11/2017 Global Cup Poly Liner, Neutral Medical Hazard Alert Class II Hospital
prostheses Device
22/11/2017 Integrity R1.2 and Integrity R3.2 Medical Recall for Class II Hospital
systems with a Precise Device Product
Treatment Table for ATM license Correction
option

Datei Levelvi
22/11/2017 Rechargeable Li-Ion Batteries Medical Recall for Class II Hospital
with incorrect firmware used in Device Product
Puritan Bennett 980 Ventilators Correction
21/11/2017 LIPITOR atorvastatin 80mg (as Medicine Recall Class III Retail
calcium) tablet blister pack
20/11/2017 Fujifilm Synapse PACS software Medical Recall for Class II Hospital
version 4.0, 4.1, 4.2, 4.3 (a Device Product
picture archiving and Correction
communication system)
20/11/2017 Pentacam AXL, with software Medical Recall for Class II Hospital
versions 1.21r01, 1.21r03, Device Product
1.21r11 and 1.21r13 Correction
20/11/2017 Spectra System/Legacy Guided Medical Recall Class II Retail
Surgery Handle Kit Inserts Device
20/11/2017 Tango Reflex - Lasers, Medical Recall for Class II Hospital
Ophthalmic Model LT5106-T Device Product
Correction
17/11/2017 Bard ArcticSun ArticGel Pads Medical Recall for Class II Hospital
Device Product
Correction
17/11/2017 Epiclone Anti-M Blood Grouping Medical Recall Class II Hospital
Reagent. An in vitro diagnostic Device
17/11/2017 Epiclone Anti-M Blood Grouping Medical Recall for Class II Hospital
Reagent. An in vitro diagnostic Device Product
medical device (IVD) Correction
16/11/2017 iChemVELOCITY Urine Medical Recall Class II Hospital
Chemistry Strips. An in vitro Device
16/11/2017 iQ200 Series Urine Microscopy Medical Recall for Class II Hospital
Analyzer with Barcode Reader Device Product
Model NFT-2100 Correction
16/11/2017 Remisol Advance Software Medical Recall for Class II Hospital
Versions 1.6-1.9, Architect Driver Device Product
Correction
15/11/2017 Foetal Haemoglobin Monoclonal Medical Recall Class II Hospital
Antibody (HBF-1). An in vitro Device
15/11/2017 ProTrack Microcatheter Medical Recall Class II Hospital
Device
15/11/2017 Signature Orthopaedics Logival Medical Hazard Alert Class III Hospital
20 degree Hooded XLPE Liner Device
15/11/2017 TunneLoc Tibial Fixation Devices Medical Hazard Alert Class II Hospital
(used during anterior cruciate Device
ligament (ACL) and posterior
cruciate ligament (PCL)
reconstruction)
14/11/2017 MAQUET HLX 2004-5 DF, HLX Medical Recall for Class II Hospital
3004-5 DF and XTEN DF Device Product
cupolas Surgical Lighting System Correction

Datei Levelvi
13/11/2017 CP5 control panels and HLM Medical Recall for Class I Hospital
bubble sensors and EP packs Device Product
manufactured prior to 10 Correction
February, 2017
13/11/2017 i-STAT 1 Analyser Software with Medical Recall for Class III Hospital
i-STAT Total â-hCG Cartridge Device Product
with software version JAMS Correction
143/CLEW A34. An in vitro
13/11/2017 METS Principal Shaft Medical Hazard Alert Class II Hospital
Device
13/11/2017 Percuvance Percutaneous Medical Recall Class I Hospital
Surgical System Device
13/11/2017 Thermofisher Remel Bactipstaph Medical Recall Class II Hospital
Latex Kits Device
10/11/2017 Accent / Anthem, Accent MRI / Medical Recall for Class II Hospital
Accent ST, Assurity / Allure and Device Product
Assurity MRI devices Correction
10/11/2017 APO-Perindropril Arginine Medicine Recall Class III Consumer
2.5mg, AUST R: 184808
8/11/2017 Disposable Reuter Tip-Deflecting Medical Recall Class II Hospital
Wire Guide Device
8/11/2017 DxH 500 Open-Vial Medical Recall for Class II Hospital
Haematology System, with Device Product
software version 1.0.2 and 1.1. Correction
device (IVD)
8/11/2017 LIFEPAK EXPRESS AED, Medical Recall Class I Retail
LIFEPAK CR Plus AED, Device
LIFEPAK 1000 defibrillator, or
LIFEPAK 500 Biphasic AED with
a pink connector
8/11/2017 Metaraminol Syringes Medicine Recall Class III Hospital
8/11/2017 Philips Brilliance 64, Ingenuity Medical Recall for Class II Hospital
Core128 and Ingenuity CT with Device Product
software version 4.1.6 Correction
8/11/2017 SOMATOM Definition AS, Medical Recall for Class I Hospital
Definition, Definition Edge, Device Product
Definition Flash and SOMATOM Correction
Force
7/11/2017 Eluvia 150mm and Innova Medical Recall Class I Hospital
200mm Stent Systems Device
7/11/2017 Preloaded hydrophobic Medical Recall Class II Hospital
intraocular lenses Device
7/11/2017 Various Optetrak Devices - Medical Recall for Class II Hospital
Spine Stiffener Screw and Device Product
Constrained Condylar (CC) Tibial Correction
Insert when used in conjunction
with Offset Tibial Tray
7/11/2017 V-PRO 60 Low Temperature Medical Recall for Class II Hospital
Sterilisation System with Device Product
VAPROX HC Sterilant Correction

Datei Levelvi
6/11/2017 Compella Air Surfaces Bed Medical Recall for Class II Hospital
System (220 - 240 V, 50 Hz), Device Product
used in conjunction with Correction
International 220 - 240 V, 50 Hz
Controllers
6/11/2017 Compounded Medications within Medical Recall Class II Hospital
CADD Medication Non-flow stop Device
Cassette Reservoirs
6/11/2017 Haemoglobin A1c (HbA1c) Flex Medical Recall for Class II Hospital
reagent cartridge used with Device Product
Dimension Vista with software Correction
version 3.6.2 or higher. An in
(IVD)
6/11/2017 SENSATION PLUS 8Fr. 50cc Medical Recall Class II Hospital
Intra-Aortic Balloon Catheter with Device
Insertion Kit & STATLOCK
6/11/2017 VITEK 2 Gram-Positive (GP) Medical Recall Class II Hospital
Identification (ID) Test Kit. An in Device
(IVD)
3/11/2017 Acetabular Cup Introducer Medical Recall Class II Hospital
(32mm) Device
3/11/2017 Alaris System Pump module Medical Recall for Class I Hospital
(LVP), Mechanism Sub- Device Product
assembly and Kit Assembly Correction
3/11/2017 Doro Sterile Disposable Skull Medical Recall Class I Hospital
Pins Device
2/11/2017 Midazolam APOTEX midazolam Medicine Recall Class I Retail
5mg/1 mL solution for injection
ampoule
1/11/2017 RHD2.5 Hex Driver, 2.5mm with Medical Recall Class II Retail
GemLock Retention, contained Device
within TSVKIT Surgical Kit
1/11/2017 Various Acuvue for Astigmatism Medical Recall Class III Retail
Contact Lenses Device
31/10/2017 Copernic2L and Eclipse2L Medical Recall for Class II Hospital
Occlusion Balloon Catheters Device Product
Correction
31/10/2017 FLEX Monoclonal Rabbit Anti- Medical Recall Class I Hospital
Human Estrogen Receptor Clone Device
EP1, Ready-to-use. An in vitro
30/10/2017 Drystar DT 2 C Hardcopy Film Medical Recall for Class II Hospital
14" x 17" Device Product
Correction
30/10/2017 Leica Proveo 8 Ophthalmic Medical Recall for Class II Hospital
Microscope System Device Product
Correction
30/10/2017 rHead Radial Head and Uni- Medical Recall Class II Hospital
Elbow System Device
30/10/2017 Veletri Consumables Kit with non Medical Recall Class II Hospital
Flow-Stop CADD Medication Device
Cassette Reservoirs

Datei Levelvi
27/10/2017 Sorin Group perfusion system – Medical Recall Class I Hospital
Heater Cooler 1T devices Device
27/10/2017 Sorin Group perfusion system – Medical Recall for Class I Hospital
Heater Cooler 3T devices Device Product
Correction
25/10/2017 Access BR Monitor used with the Medical Recall for Class II Hospital
Access family of Immunoassay Device Product
systems. An in vitro diagnostic Correction
25/10/2017 Plum 360 Infusion System Medical Recall for Class II Hospital
Device Product
Correction
25/10/2017 WECK Auto Endo5 Automatic Medical Recall Class II Hospital
Hem-o-lok Clip Appliers Device
24/10/2017 3.0T GE 6-Channel Phased Medical Recall for Class II Hospital
Array Flex Coil Device Product
Correction
24/10/2017 Dialysis Treatment Therapy Pack Medical Recall Class II Hospital
105 Device
24/10/2017 MIA FORA NGS Software Medical Recall for Class II Hospital
v3.27.0. An in vitro diagnostic Device Product
24/10/2017 Various Dimension and Medical Recall for Class II Hospital
Dimension Vista LOCI Assays. Device Product
An in vitro diagnostic medical Correction
device (IVD)
23/10/2017 AUSTRALIAN Medicine Recall Class III Hospital
RADIOISOTOPES Sodium
Iodide (I-131) 50 - 6000MBq
Therapy Capsule vial
23/10/2017 Curlin 6000 Painsmart IOD Medical Recall for Class II Hospital
Infusion Pump Power Adapter Device Product
Accessory Correction
23/10/2017 Hospira labelled MedNet Medical Recall for Class I Hospital
Medication Management Suite – Device Product
with Plum 360 Infusion System Correction
23/10/2017 Thoracic Pedicle Feeler Medical Recall Class II Hospital
Device
20/10/2017 Tracoe Twist Tracheostomy Medical Recall Class II Hospital
Tube Device
18/10/2017 FlexCath Advance Steerable Medical Recall for Class I Hospital
Sheath Device Product
Correction
18/10/2017 Liko Multirall 200 overhead lift Medical Recall for Class II Hospital
and S65 Carriage Device Product
Correction
18/10/2017 Oxford Dipper Hoist Medical Recall for Class II Retail
Device Product
Correction
18/10/2017 Oxford Dipper pool hoist Medical Recall for Class II Retail
Device Product
Correction

Datei Levelvi
18/10/2017 Philips Network Firewall 867098 Medical Recall Class II Hospital
(Cisco ASA 5506 Firewall) used Device
with the Philips IntelliVue
Information Center iX or Classic
Information Center
18/10/2017 Radiometer TCM5 FLEX / Medical Recall for Class I Hospital
BASIC Transcutaneous Monitor Device Product
Correction
17/10/2017 Beater-Positioner-Aligner Medical Recall Class II Hospital
Device
17/10/2017 Catheter Mount Medical Recall Class II Hospital
Device
17/10/2017 Ingenuity TF PET/CT System Medical Recall for Class III Hospital
with software version Device Product
4.0.3.26129 Correction
17/10/2017 Non-Flow-Stop CADD Medical Recall Class I Hospital
Medication Cassette Reservoirs Device
50 and 100mL
16/10/2017 CareLink iPro Therapy Medical Recall for Class II Hospital
Management Software MMT- Device Product
7340 Correction
16/10/2017 Pentax ED-3490TK Video Medical Recall for Class II Hospital
Duodenoscope Device Product
Correction
16/10/2017 Radiometer ABL800 series with Medical Recall for Class I Hospital
FLEXQ module. An in vitro Device Product
13/10/2017 Ceiling Unit CU5001/3 and CU 3- Medical Recall for Class II Hospital
21/23 Device Product
Correction
13/10/2017 ERGO version 1.7.3 and higher Medical Recall for Class I Hospital
and using a Multileaf Collimator Device Product
(MLC) device for planning Correction
12/10/2017 Gentamicin / Gentamicin & Medicine Recall Class II Hospital
Citrate, Syringes, Bags and Eye
Drops
11/10/2017 All Carestation 620, 650 and Medical Recall for Class I Hospital
650c Anaesthesia systems Device Product
Correction
11/10/2017 Corpus Powered Wheelchairs Medical Recall for Class II Consumer
Device Product
Correction
11/10/2017 DIMETAPP COUGH COLD & Medicine Recall Class II Retail
FLU DAYTIME/NIGHTIME
LIQUID CAPS capsule blister
pack
11/10/2017 Integra CUSA Clarity Footswitch Medical Recall Class II Hospital
packaged with CUSA Clarity Device
Console C7000

Datei Levelvi
9/10/2017 Abut Gold Friction-Fit Medical Recall Class II Retail
Device
9/10/2017 Conformable GORE TAG Medical Recall for Class I Hospital
Thoracic Endoprosthesis Device Product
Correction
9/10/2017 Midazolam 5mg/5mL ampoules Medicine Recall Class I Retail
9/10/2017 O-arm O2 Surgical Imaging Medical Recall for Class II Hospital
Correction
9/10/2017 Pilling Knife Handles Medical Recall Class II Hospital
Device
9/10/2017 Prick-Test Diagnostic Rye Flour Medicine Recall Class II Hospital
B16
9/10/2017 Sodium Iodide (I-131) Therapy Medicine Recall Class II Hospital
Capsule
9/10/2017 SureSigns VSi, VS2+ Medical Recall for Class III Hospital
Device Product
Correction
9/10/2017 Various Safeset and Transpac Medical Recall Class II Hospital
Blood Pressure Transducer Sets Device
9/10/2017 Xpert EV Assay. An in vitro Medical Recall Class II Hospital
6/10/2017 Gentamicin Injection BP 80 mg Medicine Recall Class I Consumer
in 2 mL Steriluer, 10 and 50
packs
5/10/2017 Fluorocell PLT reagent. An in Medical Recall Class II Hospital
(IVD)
4/10/2017 Infinity Dual Hemo MCable Pod Medical Recall for Class I Hospital
used with the Infinity Acute Care Device Product
System (IACS) Monitoring Correction
Solution
4/10/2017 Various Disposable Catheter Medical Recall Class I Hospital
Mounts Device
3/10/2017 Bard Max-Core Disposable Core Medical Recall Class I Hospital
Biopsy Instrument Device
3/10/2017 SOMATOM go.Up and Medical Recall for Class II Hospital
SOMATOM go. Now Device Product
Correction
29/09/2017 AIRO Mobile CT Scanner Medical Recall for Class I Hospital
Device Product
Correction
28/09/2017 Hamilton Medical C3 Ventilator Medical Recall for Class II Hospital
Device Product
Correction
28/09/2017 IntelePACS InteleViewer with Medical Recall for Class II Hospital
software version 3-5-1 to 4-15-1 Device Product
Correction
27/09/2017 Artis systems with wireless Medical Recall for Class II Hospital
footswitch Device Product
Correction

Datei Levelvi
27/09/2017 GastriSail Gastric Positioning Medical Recall Class II Hospital
System Device
27/09/2017 Mobile Detector Holder Trolley Medical Recall for Class II Hospital
(9890-010-88152) Device Product
Correction
27/09/2017 Progressa Bed System Medical Recall for Class II Hospital
Device Product
Correction
26/09/2017 9025RHTR ABG Sampling Kit Medical Recall Class II Hospital
Device
26/09/2017 Brilliance iCT/iCP SP, CT 64, Medical Recall for Class II Hospital
Ingenuity CT/Core/Core 128 with Device Product
21/09/2017 Auriga XL 4007 Laser System Medical Recall for Class II Hospital
Device Product
Correction
21/09/2017 DELTA XTEND Reverse Medical Recall Class II Hospital
Shoulder System Modular Device
Centered and Eccentric
Epiphysis Implants
21/09/2017 ReNew Reusable Tips (Scissors, Medical Recall Class II Hospital
Graspers and Dissectors) Device
20/09/2017 Surflink Media and Surflink Medical Recall for Class III Consumer
Media 2 Device Product
Correction
19/09/2017 Auriga XL 4007 Laser System Medical Recall for Class II Hospital
Device Product
Correction
18/09/2017 Lucrin Depot Paediatric acetate Medicine Recall Class II Consumer
30mg for injection, prefilled dual
chamber syringe
18/09/2017 Thermocool Smarttouch SF Bi- Medical Recall Class II Hospital
Directional Navigation Catheter Device
15/09/2017 Freedom Healthcare Quad Medical Recall for Class II Consumer
Walkers Device Product
Correction
15/09/2017 NM Implantable Pulse Generator Medical Recall for Class II Hospital
within the Infinity and Proclaim Device Product
device families Correction
14/09/2017 Radiometer AQT90FLEX Medical Recall for Class II Hospital
Immunoassay analyser. An in Device Product
(IVD)
13/09/2017 Artis zee and Artis Q systems Medical Recall for Class II Hospital
with software version VD11C Device Product
Correction
13/09/2017 CoaguChek HS Plus/Pro Medical Recall for Class III Hospital
13/09/2017 DiaMed Q.C. System. An in vitro Medical Recall Class II Hospital
13/09/2017 Lax Sachets Medicine Recall Class II Consumer

Datei Levelvi
13/09/2017 Lentis Foldable Intraocular Medical Recall Class II Hospital
Lenses (IOL) Device
13/09/2017 MetaVision ICU version 6.0x - Medical Recall for Class II Hospital
6.9x Device Product
Correction
13/09/2017 Oxoid AST Disc - Ceftazidime Medical Recall Class II Hospital
CAZ10. An in vitro diagnostic Device
11/09/2017 Lifecodes HLA-DRB1 SSO Medical Recall for Class II Hospital
Typing Kit and HLA-DQA1/B1 Device Product
Typing Kit. An in vitro diagnostic Correction
11/09/2017 Medtronic MiniMed Infusion Sets Medical Recall Class II Consumer
Device
11/09/2017 Various Disposable Catheter Medical Recall Class II Hospital
Mounts Device
11/09/2017 Various Sage Oral Care Medical Recall Class II Hospital
Products Device
7/09/2017 Philips IntelliVue Patient Medical Recall for Class II Hospital
Monitors ECG 12-lead option Device Product
#C12 Correction
6/09/2017 Allura Xper R9 and Azurion R1.1 Medical Recall for Class II Hospital
systems with the QA Basic Device Product
Measurement tool Correction
6/09/2017 Cystoscopy Bridges Medical Recall Class II Hospital
Device
6/09/2017 Graseby 3300 Pump and Medical Recall for Class II Hospital
Graseby 3000 Series Device Product
Accessories Correction
6/09/2017 Plastic Cannula – 11 gauge Medical Recall Class II Hospital
Device
6/09/2017 TM0268 GC Sugar Set. An in Medical Recall Class II Hospital
(IVD)
4/09/2017 Slit Lamp Medical Recall for Class III Hospital
Device Product
Correction
4/09/2017 VisuMax Medical Recall for Class III Hospital
Device Product
Correction
31/08/2017 Iris Hi Lo Bed Medical Recall for Class II Hospital
Device Product
Correction
30/08/2017 Affirm Lateral Arm Upright Medical Recall for Class II Hospital
Biopsy Accessory Device Product
Correction
30/08/2017 Ausganica Soothing Herbs Medicine Recall Class III Consumer
Toothpaste
30/08/2017 Epiclone Anti N BGR - Medical Recall Class II Hospital
Immunohaematology Reagent. Device
device (IVD).

Datei Levelvi
30/08/2017 Phadia 1000 Instrument. An in Medical Recall for Class II Hospital
vitro diagnostic medical device Device Product
(IVD) Correction
30/08/2017 VITROS Chemistry Products Medical Recall for Class II Hospital
PHYT Slides. An in vitro Device Product
29/08/2017 Artis one system with DP Medical Recall for Class II Hospital
Transceiver below version 03 Device Product
Correction
29/08/2017 HeartWare HVAD Controllers Medical Recall Class II Hospital
and Heartware 1435 DC Device
Adapters
29/08/2017 Leica M525 F40 Surgical Medical Recall for Class II Hospital
Microscopes Device Product
Correction
29/08/2017 Mako THA Application User Medical Recall for Class II Hospital
Guides Device Product
Correction
29/08/2017 Various Tissu-Trans Products Medical Recall Class II Hospital
Device
29/08/2017 VITROS Immunodiagnostic Medical Recall for Class II Hospital
Products Signal Reagent. An in Device Product
(IVD)
29/08/2017 WATO EX-65 and A-Series Medical Recall for Class II Hospital
(A5/A7) anaesthesia machines Device Product
Correction
28/08/2017 Artis zee biplane and Artis Q Medical Recall for Class III Hospital
biplane systems Device Product
Correction
28/08/2017 cobas 8000 core unit with Medical Recall for Class II Hospital
software versions 5.01 and later. Device Product
device (IVD)
28/08/2017 Essure Permanent Birth Control Medical Hazard Alert Class II Hospital
Device
28/08/2017 Fortify, Fortify Assura, Quadra Medical Hazard Alert Class II Hospital
Assura, Quadra Assura MP, Device
Unify, Unify Assura and Unify
Quadra devices
23/08/2017 Kii Abdominal Troacar Medical Recall Class II Hospital
Device
23/08/2017 Remel Wellcolex Colour Shigella Medical Recall Class II Hospital
23/08/2017 Solitaire Platinum Medical Recall for Class III Hospital
Revascularisation Device Device Product
Correction

Datei Levelvi
23/08/2017 Streptex Rapid Latex Medical Recall Class II Hospital
Agglutination Test. An in vitro Device
23/08/2017 Sysmex CS-5100 Analyser. An Medical Recall for Class II Hospital
(IVD) Correction
22/08/2017 FemoSeal Vascular Closure Medical Recall Class I Hospital
System Device
22/08/2017 Pfizer (Perth) Pty Limited Medicine Recall for Class III Hospital
LIGNOCAINE 2% GEL syringe Product
Correction
21/08/2017 Immunoassay Premium and Medical Recall for Class II Hospital
Premium Plus controls when Device Product
used with ACTH assays. An in Correction
(IVD)
17/08/2017 Oh Baby! Natural Formula Medicine Recall Class II Consumer
capsules, JO LMax Extra tablets
and RUFF Natural Formula
10,000mg capsules
17/08/2017 Platinium Implantable Cardiac Medical Hazard Alert Class III Hospital
Defibrillators (ICDs) and Cardiac Device
Resynchronisation Therapy
Defibrillators (CRT-Ds)
16/08/2017 A.T.S. 2200 and A.T.S. 4000 Medical Recall for Class III Hospital
Tourniquet Systems Device Product
Correction
16/08/2017 Oncentra Brachy using versions Medical Recall for Class II Hospital
4.5, 4.5.1 and 4.5.2 Device Product
Correction
16/08/2017 Philips Brilliance iCT Medical Recall for Class II Hospital
Device Product
Correction
16/08/2017 Rechargable Lithium Ion Battery Medical Recall for Class II Hospital
used in Beneview T1 Patient Device Product
Monitors Correction
15/08/2017 Abbott RealTime HIV-1 Assay. Medical Recall Class II Hospital
device (IVD)
15/08/2017 Disposable Expandable Adult Medical Recall Class II Hospital
22mmID Expandable Device
Anaesthetic Circuits
14/08/2017 Nicolet Elite Doppler Probe 2 Medical Recall for Class II Hospital
MHz and 3 MHz Obstetric, 5 Device Product
MHz Vascular Correction
11/08/2017 Heparin 5000 IU/5mL injection Medicine Recall Class I Consumer
50 pack and Lignocaine
50mg/5mL x 50
Antennas with Thermosphere Device
Technology
10/08/2017 Janus and Janus G3 Automated Medical Recall for Class III Hospital
Workstation Device Product
Correction

Datei Levelvi
10/08/2017 Medtronic MyCareLink Remote Medical Recall for Class II Hospital
Monitors Device Product
Correction
10/08/2017 nanOss Bioactive 10cc Bone Medical Recall Class III Hospital
Void Filler Device
10/08/2017 Vanguard Open Box Posterior Medical Hazard Alert Class II Hospital
Stabilised Femoral Components Device
10/08/2017 VITROS Performance Verifier II. Medical Recall for Class II Hospital
10/08/2017 Vygon Umbilical Catheters Medical Recall Class II Hospital
Device
9/08/2017 balanSys RP Tibial Plateau Medical Recall Class II Hospital
TiNbN cem Device
9/08/2017 D-Rad Titanium 2.4mm x 10mm Medical Recall Class II Hospital
Locking Screw T7 Self-Tapping Device
9/08/2017 Rigid Arm Supports Medical Recall Class I Hospital
Device
8/08/2017 Fujifilm MS Swivel Arm Medical Recall for Class II Hospital
Device Product
Correction
8/08/2017 illumigene Malaria Kit. An in vitro Medical Recall Class III Hospital
8/08/2017 PLEGIOX Cardioplegia Heat Medical Recall for Class I Hospital
Exchanger Device Product
Correction
7/08/2017 70mL Centrifuge Bowl Medical Recall Class II Hospital
Device
7/08/2017 AIRO Mobile CT Scanner Medical Recall for Class II Hospital
Device Product
Correction
7/08/2017 ARROW Pressure Injectable Medical Recall Class III Hospital
PICC Kit Device
7/08/2017 Gentian Cystatin C Calibrator Kit. Medical Recall Class II Hospital
device (IVD)
7/08/2017 Human IgM kit for use on Medical Recall for Class II Hospital
SPAPLUS Device Product
Correction
7/08/2017 Maquet/Datascope Intra-Aortic Medical Recall for Class II Hospital
Balloon Pump (IABP) Device Product
Correction
7/08/2017 Metamucil Natural Granular Medicine Recall Class III Retail
Original with Sugar (48 doses)
7/08/2017 Polarstem Cardan for 21000438 Medical Recall Class II Hospital
Device
3/08/2017 S7XTRA Concentrate 5 Litre Medical Recall Class II Hospital
bottles Device
3/08/2017 VITEK MS Clinical Systems. An Medical Recall for Class II Hospital
(IVD) Correction

Datei Levelvi
2/08/2017 ImmunoCAP Allergen f205, Medical Recall Class III Hospital
Herring. An in vitro diagnostic Device
2/08/2017 Pentax Ultrasound Video Medical Recall for Class II Hospital
Bronchoscope Device Product
Correction
1/08/2017 Ultrasound Upper GI Video Medical Recall for Class II Hospital
Scopes Device Product
Correction
27/07/2017 ProBP 2400 Digital Blood Medical Recall Class II Hospital
Pressure Device Device
27/07/2017 Ultrasonic Mixer cover (USM) 3. Medical Recall for Class II Hospital
26/07/2017 Various Trauma and Extremity Medical Recall Class II Hospital
Instruments (drill bits, screw taps Device
and saw blades)
25/07/2017 Fujifilm Digital Mammography Medical Recall for Class II Hospital
Correction
25/07/2017 Heater Unit HU 35 Medical Recall for Class I Hospital
Device Product
Correction
24/07/2017 Maquet Heater-Cooler Unit HCU Medical Recall for Class I Hospital
40 Device Product
Correction
21/07/2017 Philips Sync Cables and Philips Medical Recall Class II Hospital
ECG Out Cables Device
20/07/2017 Allura Xper FD20 R8.2 Medical Recall for Class III Hospital
Device Product
Correction
20/07/2017 CareScape Patient Data Module Medical Recall for Class II Hospital
(PDM) with software v2.6 Device Product
Correction
20/07/2017 Essure Permanent Birth Control Medical Recall for Class II Hospital
Correction
20/07/2017 Mueller Hinton E Agar (MHE) Medical Recall Class II Hospital
Device
20/07/2017 Various Microgenics Applications Medical Recall for Class II Hospital
Sheets. An in vitro diagnostic Device Product
19/07/2017 ARCTIC SUN 5000 Temperature Medical Recall for Class II Hospital
Management System (220-240 V Device Product
Australia) Correction
19/07/2017 Astral 100 and 150 ventilators Medical Recall for Class I Consumer
Device Product
Correction
19/07/2017 JTS Drive Unit Medical Recall Class II Hospital
Device
19/07/2017 Thin and Radial Osteotome Medical Recall Class II Hospital
Blades Device

Datei Levelvi
18/07/2017 Medtronic Spinous Process Medical Recall for Class I Hospital
Clamps Device Product
Correction
14/07/2017 Aequalis Ascend Flex Shoulder Medical Recall Class II Hospital
System PTC Humeral Stems Device
14/07/2017 Euphora Semi-Compliant Rapid Medical Recall Class I Hospital
Exchange Balloon Dilatation Device
Catheter
14/07/2017 HF-Resection Electrodes Medical Recall for Class I Hospital
Device Product
Correction
12/07/2017 E.T.O.I.L.E system – E.TO.I.L.E Medical Recall Class II Hospital
extension table (leg holder used Device
in total hip arthroplasty)
12/07/2017 Multiple AxiEM ENT Suction Medical Recall Class I Hospital
Instruments Device
12/07/2017 SoKINOX NO (Nitric Oxide) Medical Recall for Class II Hospital
Delivery and Monitoring System Device Product
Correction
12/07/2017 Synchron Systems Salicylate Medical Recall for Class II Hospital
Reagent. An in vitro diagnostic Device Product
11/07/2017 Alere HIV Combo. An in vitro Medical Recall for Class II Hospital
Correction
11/07/2017 Fusion Pushing Catheter Medical Recall Class III Hospital
Device
11/07/2017 Heron Toilet and Bath Chair Medical Recall for Class II Hospital
Device Product
Correction
11/07/2017 HomeChoice Pro Automated PD Medical Recall for Class I Hospital
Cycler and HomeChoice Claria Device Product
APD System Correction
11/07/2017 Mako Internal cPCI Card Cage Medical Recall for Class II Hospital
Device Product
Correction
11/07/2017 Nitinol RF Reusable Electrodes Medical Recall for Class I Hospital
Device Product
Correction
11/07/2017 syngo Workflow MLR using Medical Recall for Class I Hospital
Portal Radiologist Device Product
Correction
11/07/2017 Various Immunochemistry Medical Recall for Class I Hospital
modules. An in vitro diagnostic Device Product
7/07/2017 cobas e 411 analyser. An in vitro Medical Recall for Class II Hospital
Correction
7/07/2017 DigitalDiagnost Release 3.1.x Medical Recall for Class II Hospital
Device Product
Correction

Datei Levelvi
6/07/2017 ADVIA Chemistry Products - Medical Recall for Class II Hospital
Ammonia, Salicylate and Alanine Device Product
Aminotransferase Assays. An in Correction
(IVD)
6/07/2017 Dimension Clinical Chemistry Medical Recall for Class II Hospital
System and Dimension Vista Device Product
System. An in vitro diagnostic Correction
5/07/2017 Emblem and SQ-RX Medical Recall for Class I Hospital
Subcutaneous-Implantable Device Product
Cardiac Defibrillators (S-ICDs) Correction
4/07/2017 Maquet/Datascope Intra-Aortic Medical Recall for Class I Hospital
Balloon Pump (IABP) Device Product
Correction
4/07/2017 MOSAIQ and Treating on linear Medical Recall for Class II Hospital
accelerators with the RATM Device Product
license Correction
3/07/2017 Haemophilus Test medium Medical Recall Class II Hospital
(HTM). An in vitro diagnostic Device
29/06/2017 Sysmex XN-450, XN-550 & other Medical Recall for Class II Hospital
XN-L series Automated Device Product
Haematology Analysers. An in Correction
(IVD)
28/06/2017 Zenith Alpha Thoracic Medical Recall Class I Hospital
27/06/2017 Bard ArcticSun ArticGel Pads Medical Recall for Class III Hospital
Device Product
Correction
27/06/2017 Codan Extension Set with T Medical Recall Class II Hospital
Connector Device
27/06/2017 Comprehensive Nano Humeral Medical Recall for Class II Hospital
Component PPS Device Product
Correction
27/06/2017 Coulter LH and HmX Analysers. Medical Recall for Class I Hospital
27/06/2017 Recapper for the AutoMate 2500 Medical Recall for Class II Hospital
Family. An in vitro diagnostic Device Product
medical device (IVD). Correction
27/06/2017 Sealing Caps (A0282 and Medical Recall Class II Hospital
A0313) used with compatible Device
endoscopy instruments
27/06/2017 Trauma Guide Wires, 70cm Medical Recall Class II Hospital
Device
26/06/2017 ArjoHuntleigh Flowtron ACS900 Medical Recall for Class I Hospital
Active Compression System Device Product
Correction

Datei Levelvi
26/06/2017 Pivot, Pivot Hygiene, Pivot Medical Recall Class II Consumer
Hammock and Tony Pringle clip Device
style sling with the keyhole clip
fastening
26/06/2017 Pre-Transfusion Blood Testing Medical Recall for Class II Hospital
System PK7300 Automated Device Product
Microplate System. An in vitro Correction
26/06/2017 Promed High Concentration Medical Recall Class II Hospital
Oxygen Masks, Elongated Device
(under chin), Adult Med
Concentration
26/06/2017 Unomedical High Concentration Medical Recall Class I Hospital
Oxygen Masks Device
23/06/2017 Artis Systems in conjunction with Medical Recall for Class I Hospital
Artis Table Device Product
Correction
23/06/2017 BacT/ALERT BPN Culture Medical Recall Class II Hospital
Bottles. An in vitro diagnostic Device
23/06/2017 BK Virus R-gene Real-time Medical Recall for Class I Hospital
Detection and Quantification Kit. Device Product
device (IVD)
23/06/2017 Hospira Plum 360 Infusion Medical Recall for Class I Hospital
Correction
23/06/2017 Kleihauer Medical Recall Class III Hospital
Device
22/06/2017 iGUIDE software 2.2 Medical Recall for Class I Hospital
Device Product
Correction
22/06/2017 Medtronic DLP Adapters and Medical Recall Class I Hospital
Pressure Display Sets Device
22/06/2017 MOSAIQ Medical Oncology with Medical Recall for Class II Hospital
software version 2.50.05 and Device Product
higher Correction
22/06/2017 Sysmex CA-600 series with built- Medical Recall for Class II Hospital
in barcode reader. An in vitro Device Product
22/06/2017 Unicel DxH Slidemaker Stainer Medical Recall for Class III Hospital
Coulter Cellular Analysis Device Product
21/06/2017 Accu2ipMTA Applicator Medical Recall Class II Hospital
Device
21/06/2017 Encore 26 Inflation Device Single Medical Recall Class II Hospital
Pack Device
19/06/2017 Nordic Neuro Lab Headphones Medical Recall for Class II Hospital
used with Siemens MRI systems Device Product
Correction

Datei Levelvi
14/06/2017 HeartMate 3 Left Ventricular Medical Hazard Alert Class II Hospital
Assist System (LVAS) Device
14/06/2017 Multiplate Analyser. An in vitro Medical Recall for Class II Hospital
Correction
14/06/2017 Valproic Acid and Antibiotic TDM Medical Recall for Class II Hospital
Multi-Calibrator. An in vitro Device Product
diagnostic medical device (IVD). Correction
14/06/2017 Various Microgenics Application Medical Recall for Class II Hospital
Sheets. An in vitro diagnostic Device Product
13/06/2017 Caliber Inflation Device Medical Recall Class II Hospital
Device
13/06/2017 Flocare Gastrotomy Tubes (G- Medical Recall for Class II Consumer
tube) ENFit connector Device Product
Correction
13/06/2017 GC80 Diagnostic X-Ray system Medical Recall for Class II Hospital
Device Product
Correction
9/06/2017 Amlodipine Sandoz 5mg tablets Medicine Recall Class II Consumer
9/06/2017 Calibrator 30 (2 pack) used with Medical Recall Class II Hospital
ADVIA Centaur Enhanced Device
Estradiol (eE2) on the ADVIA
Centaur, Centaur XP and
Centaur XPT systems. An in vitro
9/06/2017 Rosa One 3.1 Medical Recall for Class I Hospital
Device Product
Correction
9/06/2017 Valpam 5, 5mg tablets Medicine Recall Class I Consumer
8/06/2017 cobas omni MGP Reagent when Medical Recall for Class III Hospital
used with cobas MPX assay. An Device Product
(IVD)
8/06/2017 Infinity Acute Care Monitoring Medical Recall for Class I Hospital
System (IACS) used with Device Product
Kontron C500 Cockpit Correction
8/06/2017 r ex-tem reagent. Medical Recall Class II Hospital
Device
8/06/2017 Shimadzu Ceiling Type X-ray Medical Recall for Class II Hospital
Tube Support Device Product
Correction
7/06/2017 Radiometer ABL90 Series Medical Recall for Class II Hospital
analysers with software version Device Product
3.2 or below. An in vitro Correction
6/06/2017 Ankle Arthrodesis Nail 611AFN Medical Recall for Class II Wholesale
Device Product
Correction
6/06/2017 Philips IntelliVue MX40 Medical Recall Class I Hospital
Wearable Patient Monitors Device
manufactured prior to the 6th of
July 2015

Datei Levelvi
5/06/2017 MULTIGENT Creatinine Medical Recall Class II Hospital
(Enzymatic) assay. An in vitro Device
5/06/2017 Organ Care System (OCS) Heart Medical Recall for Class II Hospital
system - OCS Heart Console Device Product
Correction
5/06/2017 Phenocell B 0.8% and 3% and Medical Recall for Class II Hospital
Abtectcell III 0.8%RhD. An in Device Product
(IVD)
2/06/2017 Alcon LuxOR LX3 Microscope Medical Recall for Class II Hospital
Floor Stand Device Product
Correction
2/06/2017 MiniMed 640G Insulin Infusion Medical Recall for Class I Consumer
Pump Device Product
Correction
1/06/2017 Access Total T3, Access Medical Recall for Class II Hospital
Thyroglobulin, Access Free T4, Device Product
Access GI Monitor Correction
Immunoassays. An in vitro
1/06/2017 DRX Revolution Mobile X-Ray Medical Recall for Class II Hospital
Correction
1/06/2017 DuraDiagnost Release 1.0, 2.0, Medical Recall for Class I Hospital
3.0 X-Ray systems Device Product
Correction
1/06/2017 OptiLite Multi-Use Holmium Medical Recall Class II Hospital
Laser Fibers Device
1/06/2017 PrepPlus & PrepPlus 2. An in Medical Recall for Class II Hospital
(IVD) Correction
31/05/2017 Stemetil 5mg Tablets Medicine Recall Class II Consumer
30/05/2017 Cook Multi-Use Holmium Laser Medical Recall for Class II Hospital
Fibers Device Product
Correction
30/05/2017 DxH 500 Haematology Analyser, Medical Recall for Class II Hospital
with software version 1.0.2. An in Device Product
(IVD)
30/05/2017 F-18 FDG Injection Medicine Recall for Class III Hospital
Product
Correction
30/05/2017 Laser Guide, Endotherapy, Medical Recall Class I Hospital
single use - TXMF600BFS Device
Fibres, when using pullback
device
30/05/2017 VueOptic Visualisation Source & Medical Recall for Class II Hospital
Flexor Vue Deflecting Device Product
Endoscopic System Correction
29/05/2017 Randox Liquid Cardiac Controls Medical Recall for Class II Hospital
when used with CKMB and Device Product
Myoglobin assays. An in vitro Correction

Datei Levelvi
29/05/2017 Various Terumo Introducer Kits Medical Recall Class II Hospital
Device
26/05/2017 Blooms The Chemist (BTC) Medicine Recall Class II Consumer
Paracetamol Codeine tablets,
BTC Rosuvastatin 10mg tablets
and APOTEX-Pantoprazole
20mg and 40mg tablets
26/05/2017 N Protein Standard SL and N/T Medical Recall for Class II Hospital
Protein Controls SL when used Device Product
with N Antiserum to Human Correction
Ceruloplasmin. An in vitro
26/05/2017 PROT 1 CAL and PROT 1 CON Medical Recall for Class II Hospital
when used with Dimension Vista Device Product
CER Flex Reagent Cartridge. An Correction
(IVD)
26/05/2017 ROSA Brain and ROSA One Medical Recall for Class I Hospital
Surgical Robots Device Product
Correction
26/05/2017 Valium 5mg tablets Medicine Recall Class I Consumer
25/05/2017 ALBAclone Advanced Partial Medical Recall Class II Hospital
RhD Typing Kit. An in vitro Device
24/05/2017 V-Lyte Dilution Check & V-Lyte Medical Recall for Class II Hospital
Integrated Multisensor Device Product
Technology (IMT). An in vitro Correction
23/05/2017 Endo Peanut 5mm Device Medical Recall Class II Hospital
Device
23/05/2017 Philips V60 non-invasive Medical Recall for Class I Hospital
ventilator Device Product
Correction
22/05/2017 Dynabeads HLA Class II and Medical Recall Class II Hospital
Dynabeads HLA Cell Prep II. An Device
(IVD)
19/05/2017 1322 3M Comply Lead Free Medical Recall Class III Hospital
Steam Indicator Tapes & 1355 Device
3M Comply Lead Free Steam
Indicator Tapes for Disposable
Wraps
19/05/2017 Kii abdominal trocars Medical Recall Class II Hospital
Device
19/05/2017 OEC Elite systems Medical Recall for Class II Hospital
Device Product
Correction
19/05/2017 Philips IntelliVue Neuromuscular Medical Recall Class II Hospital
Transmission (NMT) Patient Device
Cables
18/05/2017 Carestation 620, 650 and 650c Medical Recall for Class I Hospital
A1 Anaesthesia devices Device Product
Correction

Datei Levelvi
18/05/2017 DigitalDiagnost Release 3.1.x Medical Recall for Class III Hospital
Device Product
Correction
18/05/2017 Sysmex XN-10 and XN-20 Medical Recall for Class II Hospital
Automated Haematology Device Product
Analysers. An in vitro diagnostic Correction
17/05/2017 AbbVie Percutaneous Medical Recall for Class III Hospital
Endoscopic Gastronomy and Device Product
Jejunal tubing kits (AbbVie PEG Correction
and AbbVie J)
17/05/2017 LABType DNA Typing Tests (for Medical Recall for Class II Hospital
transplant compatibility analysis). Device Product
device (IVD).
16/05/2017 Miele washer-disinfectors when Medical Recall for Class II Hospital
connected to an in-house Device Product
network Correction
16/05/2017 Spectra Optia Apheresis Medical Recall for Class II Hospital
Systems Device Product
Correction
16/05/2017 Trauma Implants - intramedullary Medical Recall Class II Hospital
nails Device
16/05/2017 UniCel DxH 800 Coulter Cellular Medical Recall for Class I Hospital
Analysis System and UniCel Device Product
DxH 600 Coulter Cellular Correction
Analysis System
15/05/2017 cobas 4800 HPV Medical Recall Class III Hospital
Amplification/Detection Kit. An in Device
(IVD)
15/05/2017 Synchron Systems Microalbumin Medical Recall Class II Hospital
(MA) Reagent Device
12/05/2017 Carina Mobile Lifts Medical Recall for Class II Consumer
Device Product
Correction
12/05/2017 Microcatheter SONIC 1.5F Medical Recall Class II Hospital
Device
12/05/2017 Ultrasound Probe Cover Medical Recall Class I Hospital
(Telescopic folded with gel); and Device
10/05/2017 Asserachrom Von Willebrand Medical Recall Class II Hospital
Factor (VWF):Collagen (CB). An Device
(IVD).
10/05/2017 Ovatio, Paradym, Paradym RF Medical Recall for Class II Hospital
and Intensia Implantable Device Product
Cardioverter Defibrillators (ICDs) Correction
and Cardiac Resynchronisation
Therapy Defibrillators (CRT-Ds)
9/05/2017 Acor and Integrale primary Medical Recall for Class II Hospital
femoral stem with modular neck Device Product
Correction

Datei Levelvi
9/05/2017 Endoscopic Curved Needle Medical Recall Class II Hospital
Driver, LapSac Introducer and Device
LapSac Introducer Set
9/05/2017 Polysorb Braided Absorbable Medical Recall Class II Hospital
Suture and EndoStitch Loading Device
Unit with Polysorb Suture
9/05/2017 Wingman35 Crossing Catheters Medical Recall Class I Hospital
Device
8/05/2017 Cook Pereyra-Raz Ligature Medical Recall Class II Hospital
Carrier, Stamey Needle and Device
Clarke-Reich Laparoscopic Knot
Pusher
8/05/2017 ETEST ETP32 (Ertapenem) WW Medical Recall for Class II Hospital
B30. An in vitro diagnostic Device Product
medical device (IVD) for Correction
Antimicrobial susceptibility
testing.
8/05/2017 Medtronic SynchroMed II Pumps Medical Hazard Alert Class I Hospital
Device
8/05/2017 Prosigna Breast Cancer Medical Recall Class III Hospital
Prognostic Gene Signature Device
Assay. An in vitro diagnostic
4/05/2017 Sysmex XN-550 Automated Medical Recall for Class II Hospital
Haematology Analyser. An in Device Product
(IVD)
3/05/2017 Jackson-Pratt Perforated and Medical Recall Class II Hospital
Hemaduct Wound Drainage Device
Systems
2/05/2017 Abilify Maintena aripiprazole (as Medicine Recall Class II Retail
monohydrate) 400 mg powder
and solvent for prolonged
release suspension for injection
2/05/2017 ARCHITECT Free T4 Reagent. Medical Recall for Class II Hospital
2/05/2017 Meducore Easy Automatic Medical Recall for Class I Retail
External Defibrillator (AED) - Device Product
Battery Pack Correction
1/05/2017 Affixus Hip Fracture Nail Medical Recall Class II Hospital
Device
1/05/2017 Brennen Skin Graft Mesher - 4.5 Medical Recall for Class II Hospital
and 6.5 inch Device Product
Correction
1/05/2017 Corpuls3 CO2 Disposable Naso- Medical Recall for Class II Hospital
oral Adaptor Capone Device Product
Correction
28/04/2017 Omega+ Lag Screw Medical Recall Class II Hospital
Device
28/04/2017 Venture RX, OTW and CS Medical Recall Class I Hospital
Catheters Device

Datei Levelvi
27/04/2017 Alaris Syringe Pumps (GH, CC, Medical Recall for Class I Hospital
TIVA, PK and Enteral) - All Device Product
Variants Correction
27/04/2017 Artis Dialysis Systems - 230V, Medical Recall for Class I Hospital
230V Physio & 230 V Physio I Device Product
Correction
27/04/2017 Safety Clip - Hoffmann Limb Medical Recall Class II Hospital
Reconstruction Frame (LRF) Device
Bone Transport
26/04/2017 Architect Sex Hormone Binding Medical Recall for Class II Hospital
Globulin (SHBG) reagents. An in Device Product
(IVD)
26/04/2017 Healon Ophthalmic Viscosurgical Medical Recall Class II Hospital
Devices (OVD) 0.55mL Device
26/04/2017 neoBLUE LED Phototherapy Medical Recall Class II Hospital
Lights (2nd Generation) Device
26/04/2017 Prismaflex Control Unit (with Medical Recall for Class I Hospital
software versions prior to 8.10) Device Product
Correction
26/04/2017 RAPIDPoint 500 Blood Gas Medical Recall for Class II Hospital
Analyser with V2.4 Software Device Product
Correction
26/04/2017 Vitrectomy Cutter Medical Recall Class II Hospital
Device
24/04/2017 Sensis system Medical Recall for Class II Hospital
Device Product
Correction
21/04/2017 Absorb Bioresorbable Vascular Medical Recall Class I Hospital
Scaffold (BVS) System Device
21/04/2017 Access BR Monitor. An in vitro Medical Recall for Class II Hospital
Correction
21/04/2017 ADVIA Centaur / XP / XPT / CP Medical Recall Class II Hospital
Systems Insulin (IRI) assay. An Device
(IVD)
21/04/2017 Laser photocoagulator Easyret Medical Recall for Class I Hospital
software version 1.03 Device Product
Correction
21/04/2017 VITEK 2 Identification / Medical Recall for Class II Hospital
Antimicrobial Susceptibility Test Device Product
Cards. An in vitro diagnostic Correction
20/04/2017 ACQUITY UPLC Sample Medical Recall for Class II Hospital
Organisers. An in vitro diagnostic Device Product
20/04/2017 AQUIOS CL Flow Cytometer Medical Recall for Class II Hospital
utilising software versions 2.0 Device Product
and 2.0.1. An in vitro diagnostic Correction

Datei Levelvi
20/04/2017 iChemVELOCITY Automated Medical Recall for Class III Hospital
Urine Chemistry Systems Device Product
equipped with Correction
Colour/Clarity/Specific Gravity
Module. An in vitro diagnostic
20/04/2017 Mobile Digital X-Ray GM60A Medical Recall for Class II Hospital
Device Product
Correction
20/04/2017 Monopolar HF Resection Medical Recall Class II Hospital
Electrodes Device
20/04/2017 Synchron Systems Cholesterol, Medical Recall for Class II Hospital
Creatinine, HDL Cholesterol, Device Product
Lactate, Triglyceride, Uric Acid & Correction
Salicylate Reagents. An in vitro
20/04/2017 WECK Visistat 35R Disposable Medical Recall for Class III Hospital
Skin Stapler Device Product
Correction
20/04/2017 Wilson Frame Tempur Pedic Pad Medical Recall Class II Hospital
Set Device
19/04/2017 ACUSON S Family ultrasound Medical Recall for Class II Hospital
systems with software versions Device Product
VD10A or VD10C when using Correction
18L6 HD transducer
19/04/2017 EZ-Load Lens Delivery System Medical Recall Class I Hospital
Device
19/04/2017 Hyland's Teething Tablets and Medicine Recall Class II Consumer
Nighttime Teething Tablets
19/04/2017 neoBLUE blanket LED Medical Recall for Class II Hospital
Phototherapy Systems Device Product
Correction
19/04/2017 SOMATOM Force with software Medical Recall for Class II Hospital
version VA50A Device Product
Correction
19/04/2017 TB2000 Disposable t-piece infant Medical Recall Class I Hospital
resuscitation circuit with Device
adjustable PEEP
19/04/2017 Visum LED Surgical Lighting Medical Recall for Class II Hospital
system - EDS Light Device Product
Suspensions, Central Axis Correction
18/04/2017 SwiveLock SP Suture Anchor Medical Recall Class II Hospital
Device
13/04/2017 Span-K (potassium chloride) Medicine Recall Class II Consumer
600mg Tablets
12/04/2017 Newport HT70 and HT70 Plus Medical Recall for Class I Hospital
Ventilators Device Product
Correction

Datei Levelvi
11/04/2017 Dimension Troponin 1 (TNI) & Medical Recall for Class II Hospital
Dimension Vista Digoxin Device Product
(DIGXN), Estradiol (E2), Ferritin Correction
(FERR), Prolactin (PRL) &
Thyroid Stimulating Hormone
(TSH) assays. An in vitro
10/04/2017 BodyGuard Pump IV Medical Recall Class II Hospital
Administration Set Device
10/04/2017 Corpuls3 defibrillator/monitoring Medical Recall Class III Hospital
unit – Printer Paper Device
10/04/2017 Secondary Set Oncology Medical Recall Class II Hospital
Device
7/04/2017 N Latex Carbohydrate-deficient Medical Recall Class III Hospital
Transferrin (CDT). An in vitro Device
7/04/2017 ROHO High Profile and Mid Medical Recall Class II Consumer
Profile Single Compartment Device
Cushion with Sensor Ready
Technology
6/04/2017 Cook Biodesign 1-Layer Tissue Medical Recall for Class II Hospital
Graft and Cook Biodesign 4- Device Product
Layer Tissue Graft Correction
6/04/2017 LiquiBand FIX8 Hernia Mesh Medical Recall for Class II Hospital
Adhesive Fixation Device Device Product
Correction
5/04/2017 ARROW PICC Kits with Peel- Medical Recall for Class III Hospital
Away Sheath Component Device Product
Correction
5/04/2017 Philips Allura Xper X-Ray Medical Recall for Class II Hospital
Correction
5/04/2017 Solus Flexible, wire-reinforced Medical Recall Class I Hospital
laryngeal mask airway Device
4/04/2017 da Vinci Xi EndoWrist Stapler Medical Recall for Class II Hospital
Release Kit (SRK) Device Product
Correction
4/04/2017 Philips IntelliVue MX40 WLAN Medical Recall for Class II Hospital
Patient Wearable Monitor Device Product
Correction
3/04/2017 Monolisa HCV Ag-Ab ULTRA V2 Medical Recall for Class II Hospital
assay. An in vitro diagnostic Device Product
3/04/2017 NucliSENS Lysis Buffer. An in Medical Recall Class II Hospital
(IVD)
31/03/2017 iASSIST Validation Tool Medical Recall for Class II Hospital
Device Product
Correction
31/03/2017 Sample Probe Connector used Medical Recall for Class II Hospital
with cobas modules. An in vitro Device Product

Datei Levelvi
29/03/2017 Accu-Chek Connect diabetes Medical Recall for Class II Hospital
management app – Bolus Device Product
Advisor function Correction
29/03/2017 Multiple Zenith Alpha Thoracic Medical Recall for Class I Hospital
Endovascular Graft Products Device Product
Correction
28/03/2017 DBS Lead Depth Stop Medical Recall for Class I Hospital
Device Product
Correction
28/03/2017 Sysmex XN-Series Automated Medical Recall for Class II Hospital
Haematology Analysers. An in Device Product
(IVD)
27/03/2017 ADVIA Centaur BR Assay (50 Medical Recall for Class II Hospital
and 250 tests). An in vitro Device Product
27/03/2017 cobas 8000 modular analyser Medical Recall for Class II Hospital
series. An in vitro diagnostic Device Product
27/03/2017 Philips HeartStart MRx Medical Recall for Class I Hospital
Monitor/Defibrillator Device Product
Correction
24/03/2017 ADVIA Centaur BR Assay (50 Medical Recall for Class II Hospital
and 250 tests). An in vitro Device Product
24/03/2017 ROSA Brain 3.0.0 Robotic Medical Recall for Class I Hospital
Surgical Assistant Device Product
Correction
24/03/2017 VITEK MS Clinical Systems. An Medical Recall for Class II Hospital
(IVD) Correction
23/03/2017 Multiple Vivid Ultrasound Medical Recall for Class II Hospital
Products Device Product
Correction
22/03/2017 cobas 8100 BRF and URF with Medical Recall for Class II Hospital
software versions 02-xx. An in Device Product
(IVD)
22/03/2017 NC Trek Rx Coronary Dilatation Medical Recall Class I Hospital
System Device
21/03/2017 EpiPen Auto Injectors Medicine Recall Class I Consumer
21/03/2017 Xpert CT/NG Assay. An in vitro Medical Recall Class II Hospital
20/03/2017 Minop Invent 30 degrees Trocar Medical Recall Class II Hospital
D 8.3mm L 150mm Device
20/03/2017 ONLINE TDM Gentamicin. An in Medical Recall for Class II Hospital
(IVD) Correction
17/03/2017 Access 2 Family of Medical Recall for Class II Hospital
Immunoassay Systems. An in Device Product
(IVD)

Datei Levelvi
17/03/2017 Covidien Curity Eye Pad, Curity Medical Recall Class II Hospital
Eye Pad Oval, Curity Sodium Device
Chloride Dressing
Products NT-proBNP Reagent Device Product
Pack. An in vitro diagnostic Correction
16/03/2017 Brilliance Big Bore Oncology CT Medical Recall for Class II Hospital
and Radiology CT (with software Device Product
version 4.2.0) Correction
14/03/2017 AMM Flex Reagent Cartridge Medical Recall for Class II Hospital
used with Dimension Clinical Device Product
Chemistry System Correction
14/03/2017 Dimension Vista 500 Intelligent Medical Recall for Class II Hospital
Lab System and Dimension Vista Device Product
1500 Intelligent Lab System. An Correction
(IVD).
14/03/2017 FlexTherm Heater Cooler Device Medical Recall Class II Hospital
Device
14/03/2017 VIDAS 3 System (used with Medical Recall for Class III Hospital
software version 1.1.4) An in Device Product
(IVD)
10/03/2017 Cook Bush SL and Bush DL Medical Recall Class II Hospital
Ureteral Illuminating Catheters Device
10/03/2017 EliA Sample Diluent Medical Recall Class II Hospital
Device
10/03/2017 LaserEdge Knives Medical Recall Class I Hospital
Device
10/03/2017 Liaison C-Peptid Assay. An in Medical Recall for Class II Hospital
(IVD). Correction
10/03/2017 Mycophenolate Sandoz Medicine Recall Class II Retail
(capsules) 250mg
10/03/2017 Randox Myoglobin Assay Medical Recall for Class II Hospital
Device Product
Correction
10/03/2017 Thoracentesis/paracentesis kit, Medical Recall Class II Hospital
Illinois needle aspiration & Device
Jamshidi needle bone marrow
10/03/2017 TriForce Peripheral Crossing Set Medical Recall Class I Hospital
Device
9/03/2017 multiFiltratePRO devices Medical Recall for Class II Hospital
Device Product
Correction
8/03/2017 Danis Procedure Pack and Danis Medical Recall for Class II Hospital
Procedure Pack - Basic Device Product
Correction
8/03/2017 Iodine 131 Medicine Recall Class I Hospital

Datei Levelvi
8/03/2017 Wireless Foot Switch - Artis Medical Recall for Class II Hospital
systems Device Product
Correction
7/03/2017 LipiFlow System Activator Medical Recall for Class III Hospital
Device Product
Correction
7/03/2017 Sealapex Xpress Medical Recall Class II Retail
Device
6/03/2017 BrightView, BrightView X and Medical Recall for Class I Hospital
BrightView XCT with Tangential, Device Product
Radius, and Roll drive assembly Correction
6/03/2017 VisuMax Laser Medical Recall for Class II Hospital
Device Product
Correction
3/03/2017 Endurant / Endurant II 23mm Medical Recall Class I Hospital
and 25mm Bifurcated Stent Graft Device
Systems
3/03/2017 ETEST products. An in vitro Medical Recall Class II Hospital
3/03/2017 Left Double Lumen Medical Recall Class I Hospital
Endobronchial Tube with Parker Device
Flex-Tip
3/03/2017 Panocell-20 and Capture-R Medical Recall for Class III Hospital
Ready-ID. An in vitro diagnostic Device Product
VANC Reagent. An in vitro Device
2/03/2017 Artis Q Systems with A100G Medical Recall for Class II Hospital
generators Device Product
Correction
2/03/2017 Elecsys Thyroid Stimulating Medical Recall Class II Hospital
Hormone (TSH) and Elecsys Device
Parathyroid Hormone (PTH) (1-
84) when used on the cobas e
602 module. An in vitro
2/03/2017 LIFEPAK 15 Monitor/Defibrilators Medical Recall for Class II Hospital
with End-Tidal CO2 (EtCO2) Device Product
functionality Correction
2/03/2017 Medtronic StrataMR Adjustable Medical Recall Class I Hospital
Valves & Shunts used in the Device
management of hydrocephalus
2/03/2017 Screwdriver Shaft, hexagonal, Medical Recall Class II Hospital
large, diameter 3.5mm, length Device
165mm, for Quick Coupling
1/03/2017 Reflection Deadblow Mallet Medical Recall Class II Hospital
Device
28/02/2017 Artiste, Oncor and Primus Digital Medical Recall for Class II Hospital
Linear Accelerators running Device Product
Control Console software version Correction
13.0.302

Datei Levelvi
28/02/2017 ConMed Hyfrecator 2000 Medical Recall Class II Hospital
Electrosurgical Unit and Device
Accessory Packages containing
Handpiece Sheaths
28/02/2017 Getinge HS33 Sterilsers Medical Recall for Class II Hospital
Device Product
Correction
28/02/2017 MobiCath Bi-Directional Guiding Medical Recall Class II Hospital
Sheath, Small Curve Device
28/02/2017 Turon Impaction Fixture and Medical Recall Class II Hospital
RSP Monoblock Impaction Device
Fixture (found in instrument trays
- FA RSP Glenoid, FA RSP
Monoblock Ltd Release and FA
Turon Humerakl Head 2010)
28/02/2017 Various ID-Diacell Products. An Medical Recall for Class II Hospital
(IVD). Correction
27/02/2017 Aerowound Combine Dressing Medical Recall Class II Retail
ACD2040S, size 20cm x 40cm Device
27/02/2017 Liquichek Diabetes Control Medical Recall for Class II Hospital
Device Product
Correction
27/02/2017 Magnetic Silica MagSIL. An in Medical Recall Class I Hospital
(IVD).
27/02/2017 PregSure Digital Pregnancy Test Medical Recall Class II Retail
& Pregsure Pregnancy Test. An Device
(IVD).
27/02/2017 V60 Respiratory Ventilator with Medical Recall for Class I Hospital
Correction
24/02/2017 Cordis S.M.A.R.T. Flex Vascular Medical Recall Class I Hospital
Stent System Device
24/02/2017 Lotus Valve System Medical Recall Class I Hospital
Device
24/02/2017 Philips BrightView / BrightView X Medical Recall for Class II Hospital
/ BrightView XCT and BrightView Device Product
X upgrade to XCT Correction
24/02/2017 Philips Ingenuity CT system Medical Recall for Class II Hospital
Device Product
Correction
24/02/2017 Various Polyethylene Implants Medical Recall Class I Hospital
Device
23/02/2017 Ellex Prager scleral shell for Medical Recall for Class I Hospital
Biometry and 10MHZ Biometric Device Product
A Scan Probe Kit Correction
21/02/2017 ADVIA Chemistry Lactate Medical Recall for Class II Hospital
Dehydrogenase (LDLP and Device Product
LDPL). An in vitro diagnostic Correction

Datei Levelvi
21/02/2017 Atrium Thoracic Catheters, Sizes Medical Recall for Class II Hospital
8Fr & 10Fr Device Product
Correction
21/02/2017 First Response Digital Medical Recall Class III Retail
Pregnancy Test and First Device
Response Test & Reassure. An
(IVD).
21/02/2017 ImmunoCAP Allergen fx20, Medical Recall for Class III Hospital
Food. An in vitro diagnostic Device Product
17/02/2017 Biolox Forte 36mm Alumina Medical Hazard Alert Class II Hospital
Ceramic Head Device
16/02/2017 Medtronic Strata II/Strata NSC Medical Hazard Alert Class II Hospital
Valves (including Burr Hole and Device
Lumbar Peritoneal [LP]) used in
the management of
hydrocephalus
16/02/2017 Radpharm PYP kit for the Medicine Recall for Class II Hospital
production of Technetium Product
(99mTc) tin pyrophosphate Correction
powder for injection multidose
vial
15/02/2017 i-STAT1 Analyser when used Medical Recall for Class III Hospital
with i-STAT Celite Activated Device Product
Clotting Time (ACT) & Kaolin Correction
ACT Cartridges. An in vitro
15/02/2017 Steelco DS1000 Washer Medical Recall for Class II Hospital
Disinfectors with an auto Device Product
load/unload module attached Correction
14/02/2017 Artis Systems with software Medical Recall for Class II Hospital
versions VC14, VC21, VD10, Device Product
VD11 and VE10 Correction
14/02/2017 Difflam Sore Throat Ready to Medicine Recall Class II Retail
Use Iodine Gargle (povidone-
iodine 10mg/mL), 200mL Bottle
14/02/2017 Elecsys Anti-HAV assay run on Medical Recall for Class II Hospital
the Elecsys 2010 and cobas e Device Product
411 analysers, cobas e 601/602 Correction
modules and Modular Analytics
E-Module. An in vitro diagnostic
14/02/2017 HYDRO LeMaitre Valvulotome Medical Recall Class II Hospital
Devices Device
13/02/2017 Inhalo Medical Oxygen with Medical Recall for Class II Retail
Integrated Pressure Device Product
Regulator/Flowmeter Correction
13/02/2017 MiniMed 640G Insulin Infusion Medical Recall for Class I Consumer
Pump (with software version 2.6) Device Product
Correction
9/02/2017 ENDOEYE HD II Rigid Medical Recall for Class I Hospital
Videoscope Device Product
Correction

Datei Levelvi
9/02/2017 METS Modular Tumour System Medical Hazard Alert Class II Hospital
Device
9/02/2017 Philips BrightView XCT and Medical Recall for Class III Hospital
Philips BrightView X to XCT Device Product
Upgrade Kit Correction
8/02/2017 ABC1 HLA Typing Tray included Medical Recall Class II Hospital
in ABC1 / ABC2 Kits. An in vitro Device
8/02/2017 Advantx Legacy/Legacy-D Medical Recall for Class II Hospital
Radiographic and Fluoroscopic Device Product
System Correction
8/02/2017 ADVIA Centaur XPT System with Medical Recall for Class II Hospital
software versions V1.0 to V1.2. Device Product
device (IVD).
8/02/2017 AngioJet Ultra 5000A Console - Medical Recall for Class II Hospital
Foot Switch Device Product
Correction
8/02/2017 Duloxetine 30mg and 60mg Medicine Recall Class II Retail
capsules, RBX and Sandoz
8/02/2017 Immulite 2000 / Immulite 2000 Medical Recall for Class II Hospital
XPi Sex Hormone Binding Device Product
Globulin (SHBG). An in vitro Correction
8/02/2017 StarClose SE Vascular Closure Medical Recall Class II Hospital
System (VCS), International Device
Green Sheath
7/02/2017 Brainlab Offset Cup Impactor Medical Recall for Class II Hospital
Universal (blue handle) Device Product
Correction
6/02/2017 Drager V Series Ventilator with Medical Recall for Class I Hospital
the Optional PS500 External Device Product
Power Supply Unit installed Correction
6/02/2017 E.T.O.I.L.E sytem extension Medical Recall for Class II Hospital
table (leg holder) Device Product
Correction
3/02/2017 AnastoClip AC Closure System Medical Recall Class III Hospital
Device
3/02/2017 ARTISTE, ONCOR and PRIMUS Medical Recall for Class II Hospital
Digital Linear Accelerators Device Product
Correction
3/02/2017 Figulla Flex II ASD, Figulla Flex Medical Recall for Class II Hospital
II PFO and Occlutech PDA Device Product
Occluder Cardiac Occluders Correction
3/02/2017 iChemVELOCITY Automated Medical Recall for Class II Hospital
Urine Chemistry Systems. An in Device Product
(IVD).
3/02/2017 Uronav, Transperineal option - Medical Recall for Class III Hospital
Stepper with Stand Device Product
Correction

Datei Levelvi
2/02/2017 Meropenem Kabi 500mg and 1g Medicine Recall for Class II Hospital
(Powder for injection) vials Product
Correction
1/02/2017 ETEST XM256 (Cefuroxime) Medical Recall for Class II Hospital
Foam and SPB. An in vitro Device Product
1/02/2017 Lysercell WDF 2 x 4L used on Medical Recall Class II Hospital
Sysmex XN-Series Automated Device
Haematology Analysers. An in
(IVD).
1/02/2017 Valleylab Laparoscopic Handset, Medical Recall Class I Hospital
Four-Function Device
31/01/2017 Diego Elite Tubeset, Standard Medical Recall Class II Hospital
and Declog Device
31/01/2017 Glucose-6-Phosphate Medical Recall Class II Hospital
Dehydrogenase. An in vitro Device
31/01/2017 LIFEPAK 1000 Defibrillators Medical Recall for Class I Retail
Device Product
Correction
30/01/2017 Alaris System Pump module Medical Recall for Class II Hospital
(LVP) 8100 and Air-In-Line (AIL) Device Product
Sensor Kits Correction
30/01/2017 Boostrix, Havrix, Twinrix, Medicine Recall Class II Retail
Typherix, Varilrix Vaccines
30/01/2017 OER-AW Endoscope Medical Recall for Class III Hospital
Reprocessor Device Product
Correction
27/01/2017 Acecide Test Strips Medical Recall Class II Hospital
Device
27/01/2017 Alaris Syringe Module Model Medical Recall for Class II Hospital
8110 Device Product
Correction
27/01/2017 NX workstation with NX 3.0.8950 Medical Recall for Class II Hospital
image processing software Device Product
Correction
25/01/2017 BK Virus R-gene kit when used Medical Recall for Class II Hospital
on SmartCycler 2.0 platform. An Device Product
(IVD).
25/01/2017 Magnetic Silica MagSIL. An in Medical Recall for Class I Hospital
(IVD) Correction
Analysers (used with software Device Product
version 3.1 MR5). An in vitro Correction
25/01/2017 RaySearch RayStation 4.5, 4.7, Medical Recall for Class II Hospital
5, and 6 Device Product
Correction

Datei Levelvi
25/01/2017 SynchroMed II Infusion System Medical Recall for Class I Hospital
and Model 8870 Software Device Product
Application Card used in the Correction
8840 N’Vision Clinician
Programmer
25/01/2017 Sysmex XN-9000 Automated Medical Recall for Class II Hospital
Haematology System. An in vitro Device Product
24/01/2017 Clements Suction Regulators Medical Recall for Class II Hospital
Device Product
Correction
Correction
24/01/2017 IRT Screening Assay used for Medical Recall for Class II Hospital
screening newborns for cystic Device Product
fibrosis. An in vitro diagnostic Correction
Analysers (used with software Device Product
version 3.1 MR5). An in vitro Correction
23/01/2017 Innovance D-Dimer assay run on Medical Recall for Class II Hospital
Sysmex CS Systems. An in vitro Device Product
23/01/2017 LIFEPAK 15 Monitor/Defibrillator Medical Recall for Class II Hospital
Device Product
Correction
20/01/2017 Li-Ion Battery used with the Medical Recall for Class II Hospital
Cardiosave Hybrid/Rescue Intra- Device Product
aortic Balloon Pump (IABP) Correction
20/01/2017 Xpert BCR-ABL Monitor assay Medical Recall Class II Hospital
(used for monitoring patients Device
being treated for chronic
myelogenous leukaemia). An in
(IVD).
19/01/2017 Model 3200 programmer for Medical Recall for Class I Hospital
Emblem, Emblem MRI and SQ- Device Product
Rx Subcutaneous-Implantable Correction
Cardiac Defibrillators (S-ICDs)
18/01/2017 Calibrator A used with ADVIA Medical Recall Class II Hospital
Centaur FT4 (free thyroxine) Device
assay on the ADVIA Centaur,
Centaur XP, Centaur XPT
18/01/2017 ISOMed Arterial Embolectomy Medical Recall for Class II Hospital
Catheters – Single Lumen (2F & Device Product
3F) Correction
18/01/2017 Vanguard Open Box Femoral Medical Hazard Alert Class II Hospital
Components Device
17/01/2017 Comprehensive Reverse Medical Hazard Alert Class II Hospital
Shoulder Tray Device

Datei Levelvi
17/01/2017 Mammomat Inspiration System Medical Recall for Class II Hospital
with software version VB30 and Device Product
Biopsy functionality Correction
13/01/2017 Covidien Devon Light Glove Medical Recall for Class II Hospital
(included in multiple Procedure Device Product
Packs) Correction
12/01/2017 Biolo World Slimming Capsules Medicine Recall Class II Consumer
12/01/2017 Cryptococcal Antigen Lateral Medical Recall Class II Hospital
Flow Assay (CrAg LFA). An in Device
(IVD).
12/01/2017 Roth Net Standard Polyp Medical Recall Class III Hospital
Retriever U-711151 Device
11/01/2017 MEDPOR Facial and Medical Recall Class II Hospital
Oculoplastic Sizer Sets and TLS Device
Drain System
11/01/2017 Pak Lx Assay Medical Recall for Class II Hospital
Device Product
Correction
10/01/2017 ADVIA Centaur, Dimension Vista Medical Recall for Class I Hospital
& Immulite Systems Device Product
Correction
10/01/2017 Monaco (with the use of Elekta Medical Recall for Class II Hospital
Motorised Wedges) Device Product
Correction
9/01/2017 ARROW OnControl Bone Medical Recall Class II Hospital
Marrow Biopsy System Tray Device
6/01/2017 Transpac 4 Disposable Pressure Medical Recall Class II Hospital
Transducer Monitoring Kit Device
5/01/2017 Accu-Chek Connect diabetes Medical Recall for Class II Consumer
management app Device Product
Correction
5/01/2017 Covidien Devon Light Glove Medical Recall Class II Hospital
Device
5/01/2017 Plum 360 Infusion Pump, Medical Recall for Class II Hospital
Correction
4/01/2017 Dimension Clinical Chemistry Medical Recall Class II Hospital
System and Dimension Vista Device
System. An in vitro diagnostic
4/01/2017 VITROS Chemistry Products Medical Recall for Class I Hospital
Na+ Slides. An in vitro diagnostic Device Product
3/01/2017 BioFlo PICC with ENDEXO and Medical Recall Class II Hospital
PASV Valve Technology with Device
Nitinol Guidewire -
Catheterisation kit, central
venous
23/12/2016 Biograph mCT and Biograph Medical Recall for Class II Hospital
mCT Flow Device Product
Correction

Datei Levelvi
23/12/2016 Chinese Sports Injuries Pill Medicine Recall Class II Consumer
(Zhong Guo Die Da Wan)
23/12/2016 Glucose GLUC-PAP. An in-vitro Medical Recall for Class II Hospital
diagnostic medical device (IVD). Device Product
Correction
23/12/2016 iPlan RT, iPlan RT Dose and Medical Recall for Class I Hospital
BrainSCAN Device Product
Correction
23/12/2016 Mirena levonorgestrel 52 mg Medicine Recall for Class I Retail
intrauterine drug delivery system Product
Correction
23/12/2016 Nellcor RS10 SpO2 Forehead Medical Recall Class II Hospital
Sensor Device
23/12/2016 Trauma RIA Medical Recall Class II Hospital
(Reamer/Irrigator/Aspirator) Device
System
23/12/2016 UniCel DxH 600 & 800 Coulter Medical Recall for Class II Hospital
Cellular Analysis Systems. An in Device Product
(IVD).
22/12/2016 Arsenal Set-Screw, a sub- Medical Hazard Alert Class II Hospital
component of the Arsenal Spinal Device
Fixation System
22/12/2016 Imager II Angiographic Catheter Medical Recall for Class II Hospital
Device Product
Correction
22/12/2016 Imager II Angiographic Catheters Medical Recall Class II Hospital
Device
22/12/2016 Oncentra External Beam Medical Recall for Class II Hospital
(formerly known as Oncentra Device Product
MasterPlan during release of Correction
v3.x)
22/12/2016 SMF and MDF Modular Neck Hip Medical Hazard Alert Class II Hospital
Prosthesis Device
21/12/2016 Dimension Vista V-LYTE Medical Recall for Class II Hospital
Integrated Multisensor (used for Device Product
measuring Na+/K+/Cl). An in Correction
(IVD).
20/12/2016 Artis zee, Artis Q and Artis Q.zen Medical Recall for Class I Hospital
systems with software version Device Product
VD11B Correction
20/12/2016 Greatbatch Medical Offset Medical Recall for Class II Hospital
Reamer Handle Device Product
Correction
20/12/2016 sleep.safe Set, sleep.safe Set Medical Recall Class I Consumer
Plus and sleep.safe Set Paed Device
16/12/2016 Smart Site Add-on Bag Access Medical Recall Class II Hospital
Device Device
16/12/2016 Vinyl examination/treatment Medical Recall Class II Retail
glove, non-powdered Device

Datei Levelvi
15/12/2016 DePuy Synthes Impactor for Medical Recall Class II Hospital
PFNA Blade Device
15/12/2016 Medical Mattresses and Mattress Medical Recall Class II Hospital
Covers Device
15/12/2016 PreciControl Varia when used Medical Recall for Class II Hospital
with Elecsys Parathyroid Device Product
Hormone (PTH) assay on the Correction
cobas e 411 analyser. An in vitro
14/12/2016 Artiset HD SN HC Bloodlines Medical Recall for Class I Hospital
(blood tubing system used for Device Product
haemodialysis with Artis system) Correction
14/12/2016 Dräger Oxylog Transport Medical Recall for Class I Hospital
Ventilators - Oxylog 3000 and Device Product
Oxylog 3000plus Correction
14/12/2016 Merge eFilm Workstation/eFilm Medical Recall for Class II Hospital
Lite versions 2.1, 2.1.2, 3.0, 3.1, Device Product
3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 Correction
and 4.1
UPRO Slides for measurement Device
of protein in urine (using VITROS
250/350/5,1 FS/4600 and 5600
Systems). An in vitro diagnostic
13/12/2016 Amplia MRI CRT-D SureScan Medical Hazard Alert Class I Hospital
and Claria MRI CRT-D SureScan Device
13/12/2016 Bard StatLock Catheter Medical Recall for Class II Hospital
Stabilisation Device Device Product
Correction
13/12/2016 Cancellous Bone Screws 16mm, Medical Recall Class III Hospital
20mm, 25mm, 30mm, 35mm, Device
45mm, 50mm
13/12/2016 Conmed GS2000 - 50L Medical Recall for Class I Hospital
Abdominal Insufflator Device Product
Correction
13/12/2016 HICO - Variotherm 550 Medical Recall for Class II Hospital
Hypothermia/Hyperthermia Unit Device Product
Correction
13/12/2016 LQT6283LB In-line Medical Recall for Class II Hospital
leucoreduction system for red Device Product
cell concentrates with LCRD2 Correction
Leucoflex soft filter
13/12/2016 Reagent Red Blood Cells 0.8% Medical Recall for Class I Hospital
Resolve Panel C. An in vitro Device Product
13/12/2016 UniCel DxC Synchron Wash Medical Recall Class II Hospital
Concentrate II when used with Device
Thermo-Fisher Lithium reagent
(Ref A19611). An in vitro
12/12/2016 Alaris System Point of Care Unit Medical Recall for Class II Hospital
(PC unit) Device Product
Correction

Datei Levelvi
12/12/2016 Algerbrush II and Algerbrush II Medical Recall for Class I Hospital
Accessories Device Product
Correction
12/12/2016 ID-DC Screening II. An in vitro Medical Recall for Class II Hospital
Correction
12/12/2016 Philips Ingenia 1.5T and Ingenia Medical Recall for Class II Hospital
3.0T MR systems with Ingenia Device Product
MR-OR solution Correction
9/12/2016 Philips MX 16-slice CT systems Medical Recall for Class I Hospital
featured with Lung Nodule Device Product
Analysis Correction
9/12/2016 Prestige 2, Prestilix, Prestige VH, Medical Recall for Class II Hospital
Prestige SI, RFX/SFX, Legacy Device Product
and Precision 500D, ADVANTX Correction
and Innova 2000 Systems
8/12/2016 F-18 FDG Injection Medicine Recall Class III Hospital
(Fludeoxyglucose 18F)
6/12/2016 Architect Active-B12 Reagent Medical Recall Class II Hospital
device (IVD).
6/12/2016 Atrium Chest Drains Medical Recall for Class II Hospital
Device Product
Correction
6/12/2016 Quinn’s Advantage Medium with Medical Recall Class II Hospital
Hepes (In vitro fertilisation Device
culture medium)
6/12/2016 Radiometer ABL700 and Medical Recall for Class II Hospital
ABL800 series blood gas Device Product
analysers. An in vitro diagnostic Correction
6/12/2016 TB2000 Disposable t-piece infant Medical Recall Class II Hospital
resuscitation circuit with Device
adjustable PEEP
5/12/2016 CentraLink Data Management Medical Recall for Class II Hospital
Systems with software versions Device Product
v13x, v14x, v15x. An in vitro Correction
5/12/2016 Distraction Screws Packaged Medical Recall Class II Hospital
sterile Device
5/12/2016 O2Vent T Medical Recall for Class II Consumer
Device Product
Correction
2/12/2016 balanSys UNI convex Medical Hazard Alert Class II Hospital
polyethylene (PE) inlay x/5 (with Device
thickness 5)
2/12/2016 CONSERVE Shell, DYNASTY Medical Hazard Alert Class II Hospital
Metal Liner, RIM-LOCK Metal Device
Liner, LINEAGE Metal Liner
2/12/2016 Dilantin (phenytoin sodium) 30 & Medicine Recall for Class II Consumer
100 mg capsule bottles and Product
Dilantin (phenytoin) Infatabs 50 Correction
mg tablet bottle

Datei Levelvi
2/12/2016 O2Vent T Medical Recall for Class II Consumer
Device Product
Correction
1/12/2016 Medical Mattresses and Mattress Medical Recall Class II Hospital
Covers Device
30/11/2016 Biolox Delta Ceramic Hip Medical Recall for Class II Hospital
Components Device Product
Correction
30/11/2016 Homocysteine Enzymatic Assay Medical Recall Class II Hospital
used on Cobas Integra 400 Device
plus/800 analysers and cobas c
501/502 & 701/702 modules. An
(IVD).
30/11/2016 Immulite 2000 / Immulite 2000 Medical Recall Class II Hospital
XPi Intact Parathyroid Hormone Device
(iPTH) assay. An in vitro
30/11/2016 Straumann dental surgical drills Medical Recall Class II Hospital
Device
29/11/2016 Deluxe First Aid Kit Medical Recall Class II Retail
Device
29/11/2016 Femoral Head (R) MC Biological Hazard Alert Class III Hospital
PHYT Slides used on VITROS Device Product
250/350/950/5,1 FS/4600/5600 Correction
device (IVD).
25/11/2016 WECK Visistat 35W Skin Stapler Medical Recall Class II Hospital
Device
24/11/2016 Architect Toxo IgM Assay Medical Recall for Class II Hospital
Device Product
Correction
24/11/2016 Fujifilm Access Point for FDR Go Medical Recall for Class III Hospital
Flex – DR-ID 1200 AP KIT E Device Product
Correction
24/11/2016 Laerdal Compact Suction Unit 4 Medical Recall Class II Consumer
(LCSU 4) Device
24/11/2016 Nanostim Leadless Cardiac Medical Hazard Alert Class I Hospital
Pacemaker (LCP) Device
24/11/2016 SynchroMed II Implantable Drug Medical Hazard Alert Class I Hospital
Infusion Pump Device
23/11/2016 Optipac Bone Cement Medical Recall Class II Hospital
Device
23/11/2016 Philips Brilliance 64 and Medical Recall for Class II Hospital
Ingenuity CT/Core/Core128 with Device Product
software versions 4.1.6.XX030 or Correction
4.1.6.XX032
23/11/2016 Quantum Blue Calprotectin Medical Recall for Class II Hospital
Assay and Quantum Blue Device Product
Calprotectin High Range Correction

Datei Levelvi
23/11/2016 ROTAIO Cervical Disc Medical Recall for Class II Hospital
Prosthesis Device Product
Correction
22/11/2016 3R62 Pheon Modular Knee Joint Medical Recall for Class III Hospital
(External leg prosthesis) Device Product
Correction
21/11/2016 Artis zee with sw versions Medical Recall for Class II Hospital
VC21C, VD11 and Megalix Cat+ Device Product
X-Ray tubes Correction
21/11/2016 ImmunoCAP Specific IgG/IgG4 Medical Recall for Class III Hospital
i1 Control H when used with Device Product
ImmunoCAP Allergen i1, Honey Correction
bee venom. An in vitro diagnostic
21/11/2016 SynReam Flexible Shaft (re- Medical Recall Class II Hospital
usable surgical instrument Device
supplied as part of the SynReam
medullary reaming system)
21/11/2016 Xpert MRSA/SA Blood Culture Medical Recall Class II Hospital
Assay. An in vitro diagnostic Device
18/11/2016 BIOLOX delta ceramic Medical Recall for Class II Hospital
components Device Product
Correction
18/11/2016 Kasios TCP and Kages Medical Hazard Alert Class II Hospital
Device
17/11/2016 MAQUET HLS and PLS Sets Medical Recall Class I Hospital
with BIOLINE Coating Device
(extracorporeal support sets)
16/11/2016 ADVANCE HA Coated Medical Hazard Alert Class II Hospital
TitaniumTibial Bases, all sizes Device
16/11/2016 EasySept HYDRO+ (3% Medical Recall Class II Retail
hydrogen peroxide) Cleaning & Device
Disinfecting Solution (Contact
lens care kit)
16/11/2016 Neuro Flap Fix Kit (used for Medical Recall Class II Hospital
fixation of cranial bone flaps and Device
fractures)
16/11/2016 Pico 70 Arterial blood sampler Medical Recall Class I Hospital
(used with Radiometer Blood Device
Gas Analysers)
16/11/2016 Source Administration Sets Medical Recall Class I Hospital
(SAS) used with the Medrad Device
Intego PET Infusion System
16/11/2016 Supergloves Vinyl Examination Medical Recall Class II Retail
Gloves, powdered & powder free Device
16/11/2016 Xhibit Central Station, software Medical Recall for Class III Hospital
version 1.1.5 Device Product
Correction
14/11/2016 ARROW OnControl System Medical Recall Class II Hospital
Trays Device

Datei Levelvi
14/11/2016 Du Huo Ji Sheng Tang (Tuhuo & Medicine Recall Class II Consumer
Loranthus Combination), Chuan
Xiong Cha Tiao San (Ligusticum
& Tea Formula) and Dang Gui Si
Ni Tang (Tangkuei & Jujube
Combination)
14/11/2016 F-18 FDG Injection Medicine Recall Class II Hospital
(Fludeoxyglucose F 18)
14/11/2016 Monaco V 5.00 and higher Medical Recall for Class II Hospital
(Radiation therapy treatment Device Product
planning system software) Correction
11/11/2016 Lifepak15 Monitor/Defibrillator Medical Recall for Class II Hospital
with End-tidal CO2 Option Device Product
Correction
10/11/2016 Artis Q systems with s/w version Medical Recall for Class II Hospital
VD11 and Gigalix X-Ray tubes Device Product
Correction
10/11/2016 AXIOM Artis systems with s/w Medical Recall for Class II Hospital
version VB35E and Megalix X- Device Product
Ray tubes Correction
10/11/2016 Brilliance iCT/iCT SP/Big Medical Recall for Class II Hospital
Bore/6/10/16/16P/40/64 and Device Product
Ingenuity CT/Core/Core128 Correction
10/11/2016 K-Wires for T2 and Gamma Medical Recall Class II Hospital
Systems (Internal fixation wire) Device
9/11/2016 Freelite Human Lambda Free kit Medical Recall Class II Hospital
for use on SPAPLUS Device
9/11/2016 Offset Cup Reamer Handle Medical Recall Class II Hospital
Device
9/11/2016 SOMATOM Force with software Medical Recall for Class II Hospital
version VA50_SP2 (Computed Device Product
tomography x-ray system) Correction
8/11/2016 iMR Cabinet label of Brilliance Medical Recall for Class III Hospital
iCT, Ingenuity CT, Ingenuity Device Product
Core 128 Correction
7/11/2016 Lumenis FemTouch Delivery Medical Recall for Class II Hospital
System (used with AcuPulse Device Product
laser system and AcuScan120 Correction
microscanner for gynecological
treatments)
7/11/2016 SynchroMed II Model 8637 Medical Hazard Alert Class I Hospital
Implantable Drug Infusion Pump Device
4/11/2016 ARRIVE Braided Transseptal Medical Recall Class I Hospital
Sheath Device
4/11/2016 VITROS Chemistry Products C- Medical Recall for Class II Hospital
reactive protein (CRP) Slides Device Product
Correction
4/11/2016 Wallis Posterior Dynamic Medical Recall for Class II Hospital
Stabilisation System instruments Device Product
and containers Correction
3/11/2016 AU680 chemistry analysers with Medical Recall for Class II Hospital
software version 4.05. An in vitro Device Product

Datei Levelvi
3/11/2016 LMA MAD Nasal Intranasal Medical Recall Class I Hospital
Mucosal Atomisation Device Device
(used for intranasal drug
delivery)
3/11/2016 Medtronic Model 37751 Medical Recall for Class I Hospital
Recharger, in Charging Systems Device Product
used with implantable Correction
neurostimulators (INS)
3/11/2016 Monaco V 5.11 and V 5.20 (used Medical Recall for Class II Hospital
for radiation treatment planning) Device Product
Correction
3/11/2016 SOMATOM Definition AS and Medical Recall for Class II Hospital
SOMATOM Definition Flash Device Product
(Computed tomography x-ray Correction
diagnostic system)
3/11/2016 SOMATOM Definition AS and Medical Recall for Class II Hospital
SOMATOM Definition Flash Device Product
(Computed tomography x-ray Correction
diagnostic system)
2/11/2016 Atrium Trocar Catheters, Sizes Medical Recall Class II Hospital
8Fr to 32Fr Device
2/11/2016 Nellix EndoVascular Aneurysm Medical Hazard Alert Class I Hospital
Sealing System Device
2/11/2016 Radiometer TCM5 Medical Recall for Class III Hospital
transcutaneous blood gas Device Product
monitor Correction
1/11/2016 AK 98 Self-Care Haemodialysis Medical Recall for Class I Hospital
machine with software versions Device Product
1.1.0 and earlier Correction
1/11/2016 Infinity Acute Care Monitoring Medical Recall for Class I Hospital
System (IACS) with software Device Product
version VG5.0 and Microstream Correction
(Patient monitoring system)
1/11/2016 Spot-light Tissue Pre-treatment Medical Recall Class III Hospital
Kit (Antigen retrieval reagent Device
used in cellular imaging). An in
(IVD).
31/10/2016 Intuitive Surgical Endoscope Medical Recall for Class II Hospital
Instrument Control System - da Device Product
Vinci Xi Surgical System with P5 Correction
software
31/10/2016 Pressure Care Medical Medical Recall Class II Hospital
Mattresses and Mattress Covers Device
27/10/2016 Avance CS2, Avance, and Medical Recall for Class II Hospital
Amingo anaesthesia devices Device Product
with the optional large tray insert Correction
accessory installed
27/10/2016 Brainlab Knee Navigation Medical Recall Class II Hospital
System: Femoral and Tibial Device
Cutting Block Adapter Base
26/10/2016 Atropine Injection BP atropine Medicine Recall Class II Retail
sulfate monohydrate 600 mcg in
1mL (sterile) Steriluer ampoules,
10 pack

Datei Levelvi
24/10/2016 Achieva 3.0T and Ingenia 3.0T Medical Recall for Class I Hospital
MR Systems with passive Device Product
shielding in the rear wall Correction
24/10/2016 ARCHITECT Lactic Acid. An in Medical Recall for Class II Hospital
(IVD) Correction
21/10/2016 Active Knee Total Knee Medical Hazard Alert Class II Hospital
Replacement System Device
21/10/2016 TBS iNsight v. 3.0.1 (software Medical Recall for Class II Hospital
installed on bone densitometers Device Product
for estimating fracture risk) Correction
20/10/2016 Hallu-Fix Drill, Diameter 1.9mm, Medical Recall Class II Hospital
supplied in Hallu-Fix system Device
instrumentation set (used for
orthopaedic foot surgery)
20/10/2016 Human sTfR Quantikine IVD Medical Recall Class II Hospital
ELISA Kit (used as indicator of Device
iron status). An in vitro diagnostic
20/10/2016 SynReam Reaming Rod 2.5mm, Medical Recall Class II Hospital
L 650mm, sterile Device
19/10/2016 Blood Pressure Monitoring Kits Medical Recall Class II Hospital
with Transpac IV Transducers Device
19/10/2016 VITROS Immunodiagnostic Medical Recall Class II Hospital
Products Intact iPTH Reagent Device
Packs & Calibrators (used on
VITROS ECi/ECiQ/3600
Immunodiagnostic Systems, &
18/10/2016 Bard Inlay Optima Ureteral Medical Recall for Class II Hospital
Stents Device Product
Correction
18/10/2016 Chemistry Calibrator used with Medical Recall for Class II Hospital
ADVIA Chemistry Systems Device Product
Direct Bilirubin Assay (DBIL_2). Correction
device (IVD).
18/10/2016 Perceval Sutureless Aortic Heart Medical Recall for Class I Hospital
Valves (bioprosthetic heart Device Product
valve) Correction
18/10/2016 VITROS Chemistry Products Medical Recall for Class III Hospital
Calibrator Kit 25 (used on Device Product
VITROS 4600/5600 Systems Correction
and with VITROS Chemistry
Products dHDL Slides). An in
(IVD).
17/10/2016 RaySearch RayStation 5 Medical Recall for Class II Hospital
planning system) Correction
17/10/2016 Vitamin D Total 100 Tests and Medical Recall for Class II Hospital
Vitamin D Total 500 Tests (Used Device Product
with ADVIA Centaur / ADVIA Correction
Centaur XP / ADVIA Centaur
XPT Systems)

Datei Levelvi
14/10/2016 MAGNETOM Combi Dockable Medical Recall for Class I Hospital
Neurosurgery Table Device Product
Correction
13/10/2016 ALBAclone Advanced Partial Medical Recall Class II Hospital
RhD Typing Kit. An in vitro Device
13/10/2016 Eyesaline Eyewash Solution, Medical Recall Class II Consumer
32oz, for use with Eyesaline Wall Device
Station (for emergency eye
rinsing)
13/10/2016 Total Hip Software Application Medical Recall for Class II Hospital
3.1 & 3.1.1 for use with 3.0 Mako Device Product
system (Robotic surgical Correction
navigation system used during
total hip arthroplasty)
11/10/2016 4F Stiffened Micro-Introducer Medical Recall Class II Hospital
Kits (guidewire or catheter Device
introducer)
11/10/2016 Fortify, Fortify Assura, Quadra Medical Hazard Alert Class I Hospital
Assura, Unify, Unify Assura and Device
Unify Quadra
10/10/2016 Aptio Automation Modules. An in Medical Recall for Class II Hospital
(IVD). Correction
10/10/2016 Tina-quant Haemoglobin A1c Medical Recall for Class II Hospital
Gen.2 used with COBAS Device Product
INTEGRA 400 plus analyser, Correction
COBAS INTEGRA 800 analyser
and cobas c 501/502 modules.
device (IVD).
7/10/2016 Alligator Retrieval Device, Medical Recall Class I Hospital
Xcelerator Hydrophilic Guidewire Device
and Marathon Microcatheter
(with Stylet)
7/10/2016 iPlan RT Dose / iPlan RT Medical Recall for Class I Hospital
Versions 4.5.3 and 4.5.4, when Device Product
used in combination with the Correction
optional function Dose Planning
for Agility Multileaf-Collimator
(MLC)
7/10/2016 Philips IntelliVue MX40 Patient Medical Recall for Class II Hospital
Wearable Monitor s/w versions Device Product
B.05.28, B.05.29 and B.05.32 Correction
7/10/2016 Xpert HIV-1 Viral Load Assay. Medical Recall Class II Hospital
device (IVD).
6/10/2016 Devon Light Glove (Used as a Medical Recall for Class II Hospital
cover with a compatible surgical Device Product
light handle) Correction
6/10/2016 Freelite Human Kappa Free Kit Medical Recall for Class II Hospital
(use on the Beckman AU (400, Device Product
480, 640, 680, 2700, 5400) Correction
Series). An in vitro diagnostic

Datei Levelvi
6/10/2016 Invacare Birdie Lifters (Patient Medical Recall for Class II Consumer
lifters) Device Product
Correction
6/10/2016 SenoMark UltraCor MRI 14 Medical Recall for Class II Hospital
Gauge Breast Tissue Markers Device Product
(used for radiographic marking of Correction
breast biopsy sites)
5/10/2016 Clearify Visualization System Medical Recall Class II Hospital
(Laparoscopic Care Kit) Device
5/10/2016 Rack Trays used with cobas, Medical Recall for Class II Hospital
Modular Analytics and Urisys Device Product
instruments/systems. An in vitro Correction
4/10/2016 EZ-Strip 145ìm (Assisted Medical Recall Class II Hospital
reproduction microtool) Device
30/09/2016 AlignRT patient Medical Recall for Class I Hospital
positioning/tracking video Device Product
camera system (when used Correction
withTrueBeam Radiotherapy
Delivery System)
30/09/2016 Arctic Sun Temperature Medical Recall for Class II Hospital
Management System (used for Device Product
regulating the temperature and Correction
circulation of water to a vest
worn by the patient)
30/09/2016 Feather Touch Vinyl Examination Medical Recall Class II Retail
Gloves Device
29/09/2016 AVOXimeter 1000E Cuvettes Medical Recall for Class II Hospital
(used for oximetery assessment Device Product
during heart catheterisation Correction
procedures). An in vitro
29/09/2016 Zero-Gravity Radiation Medical Recall for Class II Hospital
Protection System (overhead Device Product
suspended radiation protection Correction
shield)
28/09/2016 Monaco V5.10 and V5.20 (used Medical Recall for Class II Hospital
for radiation treatment planning) Device Product
Correction
28/09/2016 STAR Instruments Kit, sterile Medical Recall Class III Hospital
packaged (used to implant Device
Scandinavian Total Ankle
Replacement System)
28/09/2016 Sterile Single Use Minor Surgery Medical Recall Class II Retail
Bipolar Cable, IEC-BC (Used for Device
connecting the bipolar
handpieces to the RF generator
for electrosurgical procedures)
23/09/2016 Radiometer TCM5 Flex Monitor Medical Recall for Class II Hospital
(non-invasive blood gas monitor) Device Product
Correction
23/09/2016 VITROS Automation Solutions Medical Recall for Class I Hospital
configured with a Thermo Device Product
Scientific Centrifuge Module. An Correction
(IVD)

Datei Levelvi
22/09/2016 Automatic QC Cartridge tHb Medical Recall for Class II Hospital
Level 1 (used with RAPIDPoint Device Product
400/405/500 instruments). An in Correction
(IVD)
22/09/2016 Chemistry 1 Calibrator (used Medical Recall for Class II Hospital
with the Dimension Vista Device Product
System). An in vitro diagnostic Correction
22/09/2016 Fludarabine Ebewe 50mg/2ml Medicine Recall Class II Hospital
concentrated injection solution (5
vials)
21/09/2016 Metagenics Nasoclear Nasal Medicine Recall Class II Consumer
Spray 30mL
21/09/2016 Spinocath G22 / G27 (Spinal Medical Recall Class I Hospital
anaesthesia kit) Device
21/09/2016 Twin-Pass dual access catheters Medical Recall Class II Hospital
Device
20/09/2016 FerriScan (software for Medical Recall for Class III Hospital
determining liver iron Device Product
concentration from MRI images) Correction
19/09/2016 Ingenuity CT system with Medical Recall for Class III Hospital
software version 4.1.5 Device Product
Correction
19/09/2016 LFIT Anatomic CoCr V40 Medical Hazard Alert Class II Hospital
Femoral Heads (Modular Device
components used in total hip
replacement procedures)
19/09/2016 MAGiC (MAGnetic resonance Medical Recall for Class II Hospital
image Compilation) on Signa Device Product
Pioneer MRI systems running Correction
application software version
DV25.1
16/09/2016 Macopharma blood bags Medical Recall for Class II Hospital
Device Product
Correction
16/09/2016 NIO-A device (Automatic Medical Recall Class II Hospital
intraosseous infusion device that Device
provides rapid, safe and easy
intravascular access through the
bone marrow)
15/09/2016 F-18 FDG Injection Medicine Recall for Class III Hospital
(Fludeoxyglucose F 18) Product
Correction
15/09/2016 Getinge ED-FLOW AER, ED- Medical Recall for Class I Hospital
FLOW SD AER (Automated Device Product
washer-disinfector for Correction
endoscopes)
15/09/2016 MAQUET operating table Medical Recall for Class II Hospital
accessories with Accessory Device Product
Adaptor 600525A0 Correction
14/09/2016 AQUIOS CL Flow Cytometer Medical Recall for Class II Hospital
Correction

Datei Levelvi
14/09/2016 C-series carry bars (used with Medical Recall for Class II Consumer
C300, C450 Manual, C625 Device Product
ceiling lifts/hoists) Correction
14/09/2016 Debriflo Ultrasonic Wound Medical Recall for Class I Hospital
Irrigation Hand-piece Device Product
Correction
14/09/2016 SIGNA Creator and SIGNA Medical Recall for Class II Hospital
Explorer (MRI System) Device Product
Correction
13/09/2016 Combur-Test and ChoiceLine 10 Medical Recall for Class II Hospital
test kits (urine test strips). An in Device Product
(IVD)
13/09/2016 Infant Warmer System (IWS) Medical Recall for Class II Hospital
Device Product
Correction
13/09/2016 Philips BV25, BV300, BV Libra, Medical Recall for Class III Hospital
BV Endura, BV Pulsera Device Product
(Fluoroscopic x-ray systems) Correction
13/09/2016 Radiometer ABL90FLEX and Medical Recall for Class I Hospital
ABL90FLEX PLUS Blood Gas Device Product
Analyser with software version Correction
below 3.2. An in vitro diagnostic
12/09/2016 Arthrex ITD Articulating Arm 300 Medical Recall for Class II Hospital
+ 350MM Device Product
Correction
12/09/2016 Pennine Healthcare Ryles Tubes Medical Recall for Class II Hospital
(used for enteral feeding) Device Product
Correction
Ingenuity CT, Core, Core128 Device Product
with software version Correction
4.1.6.XX030
12/09/2016 Plum 360 Infusion Pump, with Medical Recall for Class II Hospital
Correction
9/09/2016 RAPIDPoint 400/405 Systems Medical Recall for Class II Hospital
Measurement Cartridge (blood Device Product
gas analysers). An in vitro Correction
9/09/2016 RaySearch RayStation 2.5, 3.0, Medical Recall for Class II Hospital
3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 Device Product
(InverseArc 1.0) (Radiation Correction
therapy treatment planning
system)
8/09/2016 Coxiella burnetii IFA IgG Kit Medical Recall Class II Hospital
Device
8/09/2016 FIDS dsDNA Kit Medical Recall Class II Hospital
Device
8/09/2016 Iron Assay performed with the Medical Recall for Class II Hospital
Dimension & Dimension Vista Device Product
Systems. An in vitro diagnostic Correction

Datei Levelvi
7/09/2016 Accu-Chek Connect Diabetes Medical Recall for Class I Consumer
Management App for iPhone Device Product
(iOS) v1.2.0(.5) Correction
7/09/2016 GlucaGen HypoKit (glucagon Medicine Recall Class I Consumer
(rys) as HCl 1 mg (1 IU) powder
vial with 1 mL, pre-filled solvent
syringe)
7/09/2016 HF Cable used with ESG-400 Medical Recall for Class III Hospital
Electrosurgical Generator Device Product
(bipolar) Correction
7/09/2016 Pulmonary Patch Biological Hazard Alert Class II Hospital
7/09/2016 Resus-EZY Air Cushion Mask Medical Recall Class III Hospital
Device
6/09/2016 Panthera S3 Wheelchair Medical Recall for Class II Hospital
Device Product
Correction
6/09/2016 Tandem Bipolar Hip System Medical Hazard Alert Class II Hospital
(hemiarthroplasty hip prosthesis) Device
5/09/2016 IMMULITE Systems 1000 / 2000 Medical Recall Class II Hospital
/ 2000 XPi CMV IgM Assay Device
(used for the determination of
Cytomegalovirus (CMV). An in
(IVD)
5/09/2016 Sage Comfort impregnated cloth Medical Recall Class II Consumer
topical skin products Device
2/09/2016 Alaris GP Infusion set with Back Medical Recall Class I Hospital
Check Valve Device
2/09/2016 Sensitest Agar Medical Recall for Class II Hospital
Device Product
Correction
2/09/2016 TECNIS 1-Piece Intraocular Medical Hazard Alert Class II Hospital
Lens (IOL) with TECNIS iTEC Device
Preloaded Delivery System
PCB00
1/09/2016 Lescol 20mg Tablets Medicine Recall Class III Retail
30/08/2016 APO-Cabergoline 500mcg Medicine Recall Class II Consumer
Tablets
30/08/2016 HeartWare Ventricular Assist Medical Hazard Alert Class I Hospital
Device (HVAD) System Device
29/08/2016 Hamilton Medical C3 Ventilator Medical Recall for Class II Hospital
Device Product
Correction
29/08/2016 Hamilton Medical MR1 Ventilator Medical Recall for Class II Hospital
Device Product
Correction
29/08/2016 Ventricular Catheter Accessory Medical Recall Class II Hospital
Kit (used for external Device
cerebrospinal fluid (CSF)
drainage)

Datei Levelvi
26/08/2016 CONMED Concept Heatwave Medical Recall Class I Hospital
Electrode, 130mm x 2.3mm Device
diameter (5 per box)
(electrosurgical electrode used
for ablation of soft tissue and
coagulation of vessels)
26/08/2016 Universal Impactor/Positioner Medical Recall Class II Hospital
(used to introduce and extract Device
compatible universal window
trials and acetabular cups into
the prepared acetabulum during
total hip arthroplasty)
25/08/2016 iGUIDE with software version Medical Recall for Class II Hospital
2.2.0 (used with HexPOD evo Device Product
RT System, used for accurate Correction
patient positioning during
radiation therapy treatment)
25/08/2016 Molift Air 205 and 300 ceiling Medical Recall for Class II Consumer
hoist (a powered lifting device) Device Product
Correction
Slide Assays - GLU, LAC, TRIG, Device Product
URIC. An in vitro diagnostic Correction
24/08/2016 Dimension & Dimension Vista Medical Recall for Class II Hospital
Urine Opiates Screen assays. In Device Product
vitro diagnostic medical devices Correction
(IVDs).
24/08/2016 Medela breastpumps detachable Medical Recall Class II Consumer
wall plug component of AC Device
Power Adaptor
24/08/2016 Oxoid Antimicrobial Susceptibility Medical Recall Class II Hospital
Testing Disc - Ceftazidime Device
CAZ10. An in vitro diagnostic
24/08/2016 Viva Cardiac Resynchronisation Medical Hazard Alert Class I Hospital
Therapy Defibrillators (CRT-Ds) Device
and Evera Implantable
Cardioverter Defibrillator (ICDs)
23/08/2016 Bard EnCor Needle Guide Insert Medical Recall for Class II Hospital
(part of the EnCor Breast Biopsy Device Product
Probe) Correction
23/08/2016 syngo RT Therapist 4.3.SP1 or Medical Recall for Class II Hospital
4.3.138 or 4.3.1_AR1 or 4.2.110 Device Product
in combination with Oncology Correction
Information System (OIS),
MOSAIQ
22/08/2016 ADVIA Chemistry Triglyceride Medical Recall for Class II Hospital
Concentrated (TRIG_c) Reagent. Device Product
device (IVD)
22/08/2016 da Vinci Xi EndoWrist Stapler 45 Medical Recall Class II Hospital
Instrument Device

Datei Levelvi
22/08/2016 RAPIDPoint 400/405/500 Medical Recall for Class II Hospital
Systems and RAPIDLab Device Product
1240/1245/1260/1265 Systems Correction
(blood gas analysers). An in vitro
22/08/2016 Red top histology jars containing Medical Recall Class III Hospital
10% Neutral Buffered Formalin Device
Solution. An in vitro diagnostic
22/08/2016 Stryker Instruments Heavy Duty Medical Recall Class II Hospital
Sagittal Blade 18x0.97x90mm Device
(used to cut bone and bone
related tissue in orthopaedic
procedures)
22/08/2016 Sysmex CS-2000i and CS-2100i Medical Recall for Class II Hospital
systems (Automated blood Device Product
coagulation analysers). An in Correction
(IVD)
19/08/2016 Monaco with software versions Medical Recall for Class II Hospital
3.1 and higher (Radiation Device Product
therapy treatment planning Correction
system)
19/08/2016 QMS Everolimus Immunoassay Medical Recall Class II Hospital
(used for the therapeutic Device
monitoring of
immunosuppressant drugs). An
(IVD)
19/08/2016 UniCel DxH 600 and DxH800 Medical Recall for Class II Hospital
Coulter Cellular Analysis Device Product
18/08/2016 Flocare Infinity Pump and Infinity Medical Recall for Class II Consumer
Plus Pump (enteral feeding Device Product
pumps) Correction
18/08/2016 LifePak CR Plus and LifePak Medical Recall for Class I Retail
Express Automatic External Device Product
Defibrillators Correction
18/08/2016 syngo RT Oncologist with Medical Recall for Class II Hospital
software version 4.2.X or 4.3.X Device Product
(image processing device that Correction
can be a component of one or
more radiation therapy systems)
17/08/2016 Digital Linear Accelerators of Medical Recall for Class I Hospital
type Primus, ONCOR and Device Product
ARTISTE running Control Correction
Console software version
12.0.25 or 13.0.65 and syngo RT
Therapist running software
version 4.2.110 or 4.3.SP1
16/08/2016 Astral 100 and Astral150 Medical Recall for Class I Consumer
Ventilators - Degraded Battery Device Product
Pack Correction
15/08/2016 Ceiling Bracket, Arch 71 White Medical Recall Class II Wholesale
(used for installing Liko patient Device
lifts to wooden and concrete
ceilings)

Datei Levelvi
15/08/2016 Cemented resurfacing patellar Medical Recall Class II Hospital
implant, Ø 33mm and 36mm Device
12/08/2016 BARD Toomey Irrigation Syringe Medical Recall Class II Hospital
70cc with Resectoscope Tip, Device
Catheter Tip, Luer Adapter and
Cap
11/08/2016 Certegra Workstation used in Medical Recall Class II Hospital
conjunction with Medrad Stellant Device
CT Injection System
11/08/2016 IntelePACS InteleViewer Medical Recall for Class II Hospital
software 4-10-1 and earlier Device Product
versions (Picture archiving and Correction
communication system for
radiology)
11/08/2016 Medtronic EnVeo R Delivery Medical Recall for Class I Hospital
Catheter System (DCS) Device Product
Correction
10/08/2016 ADVIA Centaur Systems Medical Recall for Class II Hospital
Calibrator U (Myoglobin). An in Device Product
(IVD)
10/08/2016 Allen Wrench 5mm in SMR Medical Recall Class II Hospital
supplied in instrument set Device
(surgical instrument used during
implantation of SMR anatomic
and Reverse shoulder
prosthesis)
10/08/2016 e.cam and Symbia E systems Medical Recall for Class III Hospital
Device Product
Correction
10/08/2016 Renasys Transparent Film and Medical Recall Class II Hospital
Renasys Gauze Dressing Kits Device
(used to dress, protect and seal
wounds undergoing Negative
Pressure Wound Therapy
(NPWT))
10/08/2016 Scorpio Patella Clamp (used to Medical Recall Class II Hospital
hold the patella in place during Device
the cementing process)
9/08/2016 da Vinci Xi EndoWrist Stapler Medical Recall for Class I Hospital
Device Product
Correction
9/08/2016 Leongatha Delivery Pack Medical Recall for Class II Hospital
containing umbilical clamps Device Product
Correction
9/08/2016 UniCel DxH Slidemaker Stainer Medical Recall for Class I Hospital
Coulter Cellular Analysis System Device Product
Correction
8/08/2016 1.5 mm HYDRO LeMaitre Medical Recall Class II Hospital
Valvulotome, 40 cm Device
8/08/2016 Whipknot Soft Tissue Cinch #5 Medical Recall Class II Hospital
Sutures (used in assisting in the Device
harvest, preparation, and
placement of soft tissue grafts
during ligament reconstructive
surgery)

Datei Levelvi
5/08/2016 ATEC Canister (used with ATEC Medical Recall Class II Hospital
vacuum-assisted breast biopsy Device
systems)
5/08/2016 BK Virus R-gene Real-time Medical Recall for Class II Hospital
Detection and Quantification Kit Device Product
(used to measure the viral load Correction
of BK virus in whole blood,
plasma and urine samples). An
(IVD).
5/08/2016 Ethicon Mersilene Tape Medical Recall for Class III Hospital
(intended for use in circular Device Product
suture of the cervix) Correction
4/08/2016 COLESTID colestipol HCl 5 g Medicine Recall Class III Retail
granules for oral suspension,
120 sachets
4/08/2016 Lotus Valve System Medical Recall Class I Hospital
(transcatheter aortic valve Device
implantation (TAVI) system)
4/08/2016 Philips IntelliVue Patient Medical Recall for Class II Hospital
Monitors Device Product
Correction
3/08/2016 Alere INRatio / INRatio 2 PT/INR Medical Recall Class I Consumer
Monitoring System. An in vitro Device
2/08/2016 Cell Marque Rabbit Monoclonal Medical Recall Class II Hospital
Antibody. An in vitro diagnostic Device
1/08/2016 Prostate-specific antigen (PSA) Medical Recall for Class II Hospital
Assay performed on ADVIA Device Product
Centaur, Centaur XP, Centaur Correction
XPT, and Centaur CP Analysers.
device (IVD).
1/08/2016 Various Kits containing Medical Recall Class II Hospital
Anticoagulant Citrate Dextrose Device
Solution, Solution A (ACDA)
30mL Vials (Supplied in
apheresis and surgical
procedure kits)
29/07/2016 Absorb Bioresorbable Vascular Medical Recall for Class II Hospital
Scaffold (BVS) System Device Product
Correction
29/07/2016 Etest COLISTIN CO 256 WW. Medical Recall for Class I Hospital
29/07/2016 Multiple Laerdal Suction Units Medical Recall for Class II Retail
(LSU) with NiMH Battery Device Product
Correction
28/07/2016 AXIOM Artis, Artis zee and Artis Medical Recall for Class II Hospital
Q/Q.zen system (fluoroscopic Device Product
angiographic x-ray system) Correction
27/07/2016 Multiple Polishing Products Medical Recall Class II Retail
containing Optrapol (a dental Device
polishing system)

Datei Levelvi
Products Estradiol Reagent Pack Device Product
(used for the determination of Correction
estradiol in human serum). An in
(IVD)
26/07/2016 Bisolvon Chesty Natural Kids Medicine Recall Class III Wholesale
Oral Liquid, 200mL
26/07/2016 Sterrad 100NX system Medical Recall for Class III Hospital
(Sterilisation system) Device Product
Correction
25/07/2016 ADVIA Chemistry XPT System Medical Recall for Class II Hospital
Software Test Definition (TDef) Device Product
Version 1.0 disks. An in vitro Correction
25/07/2016 ImmunoCAP Specific IgE Control Medical Recall Class II Hospital
H (used to aid the diagnosis of Device
allergy or asthma). An in vitro
25/07/2016 NIM Standard Reinforced EMG Medical Recall for Class II Hospital
Endotracheal Tube Device Product
Correction
25/07/2016 Zimmer Air Dermatome II Medical Recall for Class II Hospital
Handpiece (used during skin Device Product
grafting surgeries) Correction
22/07/2016 Locking Screws Stardrive Ø 2.4 Medical Recall Class II Hospital
mm, Self-Tapping, Length 12 Device
mm, Titanium-Alloy-Niobium
Alloy (Orthopaedic bone screw)
22/07/2016 Maquet Operating Table with Medical Recall for Class I Hospital
Fixture 1002.65AO Device Product
Correction
22/07/2016 Progressa Bed System with Medical Recall for Class II Hospital
European (OIML) Version Scale Device Product
Correction
22/07/2016 Steelco Washer Disinfectors Medical Recall for Class II Hospital
(Instrument cleaner and Device Product
disinfectors) Correction
22/07/2016 Trigen Internal Hex Captured Medical Recall for Class II Hospital
Recon Screw Blue 6.4mm x Device Product
65mm (Internal fixation screw Correction
supplied as part of the
Intramedullary Nail System)
21/07/2016 G-scan Brio Magnetic Medical Recall for Class II Hospital
Resonance System Device Product
Correction
21/07/2016 Medline Procedure Packs Medical Recall for Class II Hospital
containing ConvaTec Device Product
Unomedical Brand Frazier Correction
Suction Handle
20/07/2016 Adapter for Colibri, Electric Pen Medical Recall Class II Hospital
Drive and Light Adapter for Device
Colibri and Colibri II hand piece

Datei Levelvi
20/07/2016 Medtronic O-Arm O2 Surgical Medical Recall for Class II Hospital
Imaging System (a portable, Device Product
diagnostic, fluoroscopic x-ray Correction
system)
20/07/2016 MOSAIQ Medical Oncology Medical Recall for Class II Hospital
version 2.50.05 and higher Device Product
(oncology information system Correction
used to manage workflows for
treatment planning and delivery)
20/07/2016 NucliSENS easyMAG Magnetic Medical Recall for Class I Hospital
Silica MagSIL (used with the Device Product
NucliSENS easyMag nucleic Correction
acid extraction system for the
automated extraction of total
nucleic acids (RNA/DNA) from
biological samples). An in vitro
20/07/2016 O-Arm 1000 Surgical Imaging Medical Recall for Class II Hospital
System (Portable, diagnostic, Device Product
fluoroscopic x-ray system) Correction
20/07/2016 Tecotherm Neo (a Medical Recall for Class II Hospital
heating/cooling system for use Device Product
with infants) Correction
19/07/2016 LIAISON Estradiol II Gen Assay Medical Recall for Class II Hospital
(used for the determination of Device Product
estradiol in human serum). An in Correction
(IVD)
18/07/2016 SOMATOM Definition AS, Medical Recall for Class II Hospital
Definition Edge and Definition Device Product
Flash CT scanners with coupled Correction
contrast agent injectors in
software version VA48A-SP2
15/07/2016 MultiDiagnost Eleva and Medical Recall for Class II Hospital
MultDiagnost Eleva with Flat Device Product
Detector (diagnostic fluoroscopic Correction
x-ray system)
14/07/2016 Exeter Non V40 Rasp with Medical Recall Class II Hospital
plastic handle Device
14/07/2016 Twinfix Quick-T Knot Pusher Medical Recall Class II Hospital
Suture Cutters Device
13/07/2016 Medtronic DBS Pocket Adaptor Medical Hazard Alert Class I Hospital
for use with Activa PC (Model Device
37601) and Activa RC (Model
37612) brain neuro-stimulators
13/07/2016 Synthesis, Avant & Primo2x Medical Recall for Class II Hospital
Families Adult Oxygenator Device Product
Mounting Brackets (used with Correction
Sorin 3T Heater-Cooler devices)
12/07/2016 Avenir Müller Stem 6 Lateral Medical Hazard Alert Class II Hospital
uncemented and Avenir Müller Device
Stem 4 Standard uncemented
12/07/2016 DuraDiagnost X-ray systems Medical Recall for Class II Hospital
Device Product
Correction

Datei Levelvi
12/07/2016 Frazier Suction instrument (used Medical Recall for Class II Hospital
for precision suction in spinal or Device Product
neurological surgeries) Correction
12/07/2016 RayStation 3.0, 3.5, 4.0, 4.5, 4.7, Medical Recall for Class II Hospital
and 5 Device Product
Correction
12/07/2016 Savion ED Trolley (mobile Medical Recall for Class II Hospital
stretcher) Device Product
Correction
12/07/2016 SerenoCem Granules BCG050 Medical Hazard Alert Class II Hospital
(Orthopaedic bone cement) Device
11/07/2016 Artis Systems with 19" Live Medical Recall for Class II Hospital
Display Device Product
Correction
11/07/2016 Covidien Valleylab Laparoscopic Medical Recall Class II Hospital
Wire Retractable Electrode (used Device
in laparoscopic and thoracic
surgeries for electrosurgical
cutting and coagulation)
11/07/2016 Sara Combilizer Medical Recall for Class II Hospital
Device Product
Correction
8/07/2016 Triathlon Modular Handle Medical Recall Class II Hospital
Device
7/07/2016 Merge PACS with software Medical Recall for Class II Hospital
versions 6.0MR2 and greater up Device Product
to and including 6.6.2.2, 7.0 and Correction
greater up to and including 7.0.2
(picture archiving and
7/07/2016 Quickie Q7 Manual Wheelchair Medical Recall for Class II Consumer
Device Product
Correction
7/07/2016 Sorenson’s Buffer. An in vitro Medical Recall for Class III Hospital
Correction
7/07/2016 UniCel DxC Synchron Systems Medical Recall for Class II Hospital
No Foam Reagent (used with the Device Product
UniCel DxC Synchron Clinical Correction
System). An in vitro diagnostic
6/07/2016 Merge CADstream, All versions Medical Recall for Class II Hospital
(used for breast cancer or Device Product
general MRI studies) Correction
5/07/2016 PHIL (Precipitating Hydrophobic Medical Recall Class II Hospital
Injectable Liquid) Non-Adhesive Device
Liquid Embolic System
4/07/2016 Guide Sleeve, yellow for Medical Recall for Class II Hospital
Trochanteric Fixation Nail Device Product
Advanced (TFNA) Proximal Correction
Femoral Nailing System
Products HBsAg Controls. An in Device Product
(IVD).

Datei Levelvi
4/07/2016 Zenostar MT Color and Zenostar Medical Recall Class II Retail
MT Color Impulse products Device
1/07/2016 Allura Xper R8.2 and UNIQ R1.0 Medical Recall for Class I Hospital
X-Ray Systems (diagnostic, Device Product
1/07/2016 Chlorofluor Gel 30mL and Medicine Recall Class II Consumer
250mL bottles and 100mL pump
pack
1/07/2016 General Laparoscopy Procedure Medical Recall Class II Hospital
Pack and Gynaecological Device
Laparoscopy Procedure Pack
containing CORE Suction
Irrigation Handpiece (sterile)
1/07/2016 REX Rehab and REX P Devices Medical Recall for Class II Hospital
(robotic walking device which is Device Product
worn on the lower limbs by Correction
mobility-impaired users to
provide enhanced functional
mobility for exercise and
rehabilitation purposes)
1/07/2016 Safil Quick (synthetic absorbable Medical Recall Class II Hospital
sterile surgical suture) Device
1/07/2016 VASCU-GUARD Peripheral Medical Recall Class I Hospital
Vascular Patch, 0.8 x 8cm Device
30/06/2016 Merge CADstream with software Medical Recall for Class II Hospital
versions earlier than 5.2.6. Device Product
Correction
30/06/2016 Merge iConnect Enterprise Medical Recall for Class II Hospital
Archive (iCEA) with software Device Product
versions 8.30.7 through 9.4.3, Correction
with tier 2 storage enabled
versions 8.80 through 9.4.4 (a Correction
picture archiving and
communications system)
versions: 5.30.0 and greater up Correction
to and including 9.4.3
30/06/2016 Merge OrthoCase with software Medical Recall for Class II Hospital
versions 3.7.3 and earlier (a Device Product
picture archiving and Correction
versions 6.0MR2 and greater up Device Product
to and including 6.6.2.2. Merge Correction
PACS versions 7.0 and greater
up to and including 7.0.2
versions V6.0.2.0 MR2 and Device Product
earlier (a picture archiving and Correction
30/06/2016 Volker LTC bed (with lateral Medical Recall for Class II Consumer
release button for the side rails) Device Product
Correction

Datei Levelvi
29/06/2016 Access AMH QC Kits for use Medical Recall for Class III Hospital
with Access Family of Device Product
Immunoassay Systems. An in Correction
(IVD).
29/06/2016 James Leckey Design Mygo Medical Recall for Class II Consumer
Stander Device Product
Correction
29/06/2016 Merge PACS (Amicas PACS) Medical Recall for Class II Hospital
with software versions 6.0.2.0 Device Product
MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 Correction
CU1 (used for medical imaging
acquisition)
versions 6.5.5, 6.5.6, 6.5.7, Device Product
6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, Correction
6.6.2 (picture archiving and
versions 6.6.1, 6.6.1.1, 6.6.2, Device Product
6.6.2.1, 6.6.2.2, 7.0, 7.0.1 Correction
(picture archiving and
29/06/2016 Stratus CS Acute Care Medical Recall for Class I Hospital
Diagnostics System. An in vitro Device Product
27/06/2016 ADVIA Chemistry Medical Recall Class II Hospital
Theophylline_2 Reagent Device
27/06/2016 cobas 6800 system - cobas Medical Recall for Class I Hospital
MPX, 96 tests and cobas MPX, Device Product
480 tests. An in-vitro diagnostic Correction
27/06/2016 Torque Limiting Adapter for use Medical Recall Class II Hospital
in orthopaedic and trauma Device
surgical procedures (Re-useable
surgical instrument)
24/06/2016 ADVIA Centaur XPT System. An Medical Recall for Class II Hospital
in-vitro diagnostic medical device Device Product
(IVD) Correction
24/06/2016 Aquasil Easy Mix Putty (used for Medical Recall Class III Retail
taking impressions of teeth) Device
24/06/2016 CONMED CORE Suction Medical Recall Class II Hospital
Irrigation Handpieces (used to Device
perform suction and irrigation
during endoscopic procedures)
24/06/2016 Prodisc-C Vivo Cervical Disc Medical Recall Class II Hospital
Prosthesis (part of the Prodisc-C Device
Vivo Cervical Disc Prosthesis
System)
24/06/2016 Temporary Transvenous Pacing Medical Recall Class I Hospital
Lead System Model 6416 Device
23/06/2016 da Vinci Xi 5mm-8mm Universal Medical Recall for Class I Hospital
Cannula Seal and da Vinci Xi Device Product
12mm & Stapler Universal Correction
Cannula Seal

Datei Levelvi
22/06/2016 Shipping cartons labelled as Medicine Recall Class III Hospital
Frusemide-Claris, frusemide 20
mg/2 mL, Solution for Injection
contains incorrect product
(Ondansetron 4mg/2mL ,UK
product)
21/06/2016 Medrad MRXperion MR Injection Medical Recall for Class II Hospital
Correction
21/06/2016 QIAsymphony DSP DNA Mini Medical Recall Class II Hospital
Kits. An in vitro diagnostic Device
20/06/2016 ACHILLON Minimally Invasive Medical Recall Class II Hospital
Achilles Tendon Suture System Device
20/06/2016 Sirona Dac Universal Medical Recall for Class II Retail
Combination Steriliser Device Product
Correction
20/06/2016 V-PRO 1, V-PRO 1 Plus, V-PRO Medical Recall for Class III Hospital
maX Low Temperature Device Product
Sterilisation Systems Correction
17/06/2016 Access Free T3 Reagent Kit Medical Recall for Class II Hospital
(used in the diagnosis and Device Product
monitoring of patients with Correction
thyroid disorders). An in vitro
17/06/2016 Softpac C299 (used in preparing Medical Recall Class II Hospital
dialysate for haemodialysis Device
therapies)
17/06/2016 Xenform Soft Tissue Repair Medical Recall Class II Hospital
Matrix 8cm x 12cm Device
16/06/2016 Dimension Creatinine (CRE2) Medical Recall for Class II Hospital
Flex reagent cartridge (Used with Device Product
Dimension clinical chemistry Correction
system). An in vitro diagnostic
16/06/2016 Dimension Vista Creatinine Medical Recall for Class II Hospital
(CRE2) Flex reagent cartridge Device Product
(Used with Dimension Vista Correction
system). An in vitro diagnostic
16/06/2016 GENTECH molybdenum (99Mo) Medicine Recall Class II Hospital
/ technetium (99mTc) sterile
generator for production of
sodium pertechnetate (99mTc)
injection multidose vial
15/06/2016 Alaris System Infusion PC Unit Medical Recall for Class II Hospital
Device Product
Correction
15/06/2016 Alphadent Ceka-Preciline Dental Medical Recall Class II Retail
Devices - Ceka, Revax. Preci- Device
Ball, Preci-Horix. Preci-bar and
Preci-Clip
15/06/2016 Dräger Babytherm Infant Medical Recall for Class I Hospital
Warmer Device Product
Correction

Datei Levelvi
15/06/2016 Mandible Distractor and Proximal Medical Recall Class II Hospital
Footplate (used to stabilise bone Device
and lengthen for the correction of
congenital deficiencies or post-
traumatic defects)
15/06/2016 Medtronic Midas Rex Sagittal Medical Recall Class II Hospital
Saws (used with the Medtronic Device
Integrated Power Console (IPC)
System)
15/06/2016 SERVO-i/s ventilator systems Medical Recall for Class I Hospital
with software version 8.00.00 Device Product
Correction
15/06/2016 Trident Constrained Liner Medical Recall Class II Hospital
Impactor Tips (Used for Device
implantation of Trident
Constrained Inserts during hip
arthroplasty)
15/06/2016 Vancomycin Assay (performed Medical Recall for Class II Hospital
on cobas C and Modular Device Product
Analytics P-Module) Correction
14/06/2016 BrightView X and BrightView Medical Recall for Class II Hospital
XCT with software versions 2.5.2 Device Product
and earlier, 2.5.3 and 2.5.4 Correction
14/06/2016 MOSAIQ 2.62 and higher with Medical Recall for Class II Hospital
the IQ Scripts license enabled Device Product
(Oncology information system Correction
used to manage workflows for
treatment planning and delivery)
10/06/2016 ALT and Glucose-Stat Assays Medical Recall for Class II Hospital
(used for the determination of Device Product
ALT and Glucose). An in vitro Correction
10/06/2016 Maxter Catheters Entral pH Medical Recall Class II Hospital
Indicator Strips (used to Device
determine the pH of the stomach
prior to tube feeding)
10/06/2016 Score Extension Stem for Total Medical Recall Class II Hospital
Knee Prosthesis - Cemented Device
9/06/2016 Discovery MR750w (MRI Medical Recall for Class II Hospital
System) Device Product
Correction
9/06/2016 Target Nano Detachable Coil Medical Recall Class I Hospital
(used to obstruct or occlude Device
blood flow in blood vessels)
8/06/2016 AIRVO 2 / myAIRVO 2 Medical Recall for Class III Retail
Humidifier Device Product
Correction
8/06/2016 Blood Urea Nitrogen (BUN) Flex Medical Recall for Class II Hospital
Reagent Cartridge (used with Device Product
Dimension Vista System). An in Correction
(IVD)
8/06/2016 Compella Bariatric Bed System, Medical Recall for Class II Hospital
Controllers and Air Surfaces Device Product
Correction

Datei Levelvi
8/06/2016 Herculite Ultra, Herculite XRV, Medical Recall Class III Retail
Point 4, and Premise Dental Device
Composite (used in dental
restoration)
8/06/2016 RaySearch RayStation 5 Medical Recall for Class II Hospital
Device Product
Correction
8/06/2016 STATLOCK IAB Stabilisation Medical Recall for Class II Hospital
Device Device Product
Correction
7/06/2016 Medtronic Reveal LINQ Medical Recall for Class II Hospital
Insertable Cardiac Monitor (ICM) Device Product
Correction
7/06/2016 PowerPro Ambulance Cots Medical Recall for Class II Hospital
Device Product
Correction
6/06/2016 Medtronic deep brain stimulation Medical Hazard Alert Class I Hospital
(DBS) devices Device
6/06/2016 Medtronic Deep Brain Medical Hazard Alert Class I Hospital
Stimulation (DBS) Extension Device
Models 7483 and 37086
3/06/2016 LumaDent Light Battery Charger Medical Recall Class II Retail
Device
2/06/2016 Neonate Resuscitator with Medical Recall Class II Hospital
Coded Airway & Filter Device
Resuscitator Kit
1/06/2016 Sorbsan Calcium Alignate Medical Recall Class II Hospital
Dressings (Flat, Ribbon, Device
Packing, Plus and Border) and
Sorbsan Silver Calcium Alignate
Dressing (Flat)
30/05/2016 ADVIA Centaur XPT System Medical Recall for Class II Hospital
Device Product
Correction
30/05/2016 Ethicon Physiomesh Flexible Medical Recall Class II Hospital
Composite Mesh Device
27/05/2016 Drager Ventstar Paediatric Medical Recall Class I Hospital
Circuit, used in conjunction with Device
the Dräger Oxylog 3000plus
Transport Ventilator
27/05/2016 EliA IgG Conjugate. An in vitro Medical Recall Class III Hospital
26/05/2016 ONLINE TDM Gentamicin assay Medical Recall Class II Hospital
and Preciest TDM I Calibrator. Device
device (IVD)
26/05/2016 Philips Brilliance iCT/iCT SP with Medical Recall for Class II Hospital
software version 4.1.3, 4.1.5 Device Product
Correction
25/05/2016 2016 Fluvax, 10 x 0.5ml packs Medicine Recall for Class II Hospital
Product
Correction

Datei Levelvi
25/05/2016 Monaco software versions Medical Recall for Class I Hospital
5.10.00 and higher Device Product
Correction
Ingenuity CT/Core/Core128 with Device Product
software version 4.1.3, 4.1.4 and Correction
4.1.5
25/05/2016 Self Tapping Bone Screws, 6.5 x Medical Hazard Alert Class II Hospital
20 and 6.5 x 25 Device
with software version 3.0.3 Device Product
Correction
with software version 4.0.2, 4.0.3 Device Product
and 4.0.4 Correction
23/05/2016 Hettich Centrifuge Bucket Model Medical Recall for Class II Hospital
4464-R. An in vitro diagnostic Device Product
23/05/2016 Zoledasta (Zoledronic Acid Medicine Recall Class II Hospital
5mg/100mL) injection solution
19/05/2016 Dimension Enzyme II Calibrator Medical Recall for Class II Hospital
(used with Dimension clinical Device Product
chemistry system). An in vitro Correction
19/05/2016 Dimension Vista Enzyme 2 Medical Recall for Class II Hospital
Calibrator (used on the Device Product
Dimension Vista System). An in Correction
(IVD)
19/05/2016 Hexapod iGUIDE 2.1, iGUIDE Medical Recall for Class I Hospital
2.2 Device Product
Correction
19/05/2016 Specialty Size 33mm Reduced Medical Recall Class II Hospital
Diameter Reaming Cutter Device
19/05/2016 Sterile-Packaged Knee Implants Medical Hazard Alert Class II Hospital
Device
18/05/2016 Children's Panadol 5-12 Years Medicine Recall Class II Consumer
Colourfree Suspension 48mg/mL
18/05/2016 ConMed ThermoGuard Plus Medical Recall Class I Hospital
ABC Paediatric Dual Dispersive Device
Electrodes
18/05/2016 RestoreSensor Implantable Medical Hazard Alert Class II Hospital
Neurostimulators Device
18/05/2016 TRUEresult Blood Glucose Test Medical Recall Class II Consumer
Strip (10 counts) (used with the Device
TRUEresult Blood Glucose
Monitoring System). An in vitro
17/05/2016 Laryngeal Tube Set – size 4 Medical Recall Class II Hospital
(LTS-D S4 Adult) Device

Datei Levelvi
Products AFP Reagent Packs Device Product
and Calibrators. An in vitro Correction
13/05/2016 Brilliance CT and Ingenuity CT Medical Recall for Class III Hospital
v4.1.3 and v4.1.4 Correction
13/05/2016 DigitalDiagnost Medical Recall for Class III Hospital
Device Product
Correction
13/05/2016 MSK 1.5T Extreme and Optima Medical Recall for Class II Hospital
MR430s (MRI Systems) Device Product
Correction
13/05/2016 Surgical Clipper Charger Medical Recall Class II Hospital
Device
12/05/2016 AVOXimeter System (a whole Medical Recall for Class II Hospital
blood oximeter used during heart Device Product
catheterisation procedures) Correction
12/05/2016 Brilliance CT 64-Channel with Medical Recall for Class II Hospital
Essence Technology, Ingenuity Device Product
Core, Ingenuity Core128 and Correction
Ingenuity CT, software versions
v4.1.3, v4.1.4 and 4.1.5 (used for
diagnostic computed tomography
scanning)
12/05/2016 Brilliance iCT and iCT SP, with Medical Recall for Class II Hospital
software versions v4.1.3 and Device Product
v4.1.5 Correction
12/05/2016 LIFECODES HLA-C eRES SSO Medical Recall for Class II Hospital
Typing Kit. An in vitro diagnostic Device Product
12/05/2016 MX 16-slice CT x-ray systems Medical Recall for Class II Hospital
with software version Device Product
v1.1.4.21426. Correction
12/05/2016 Resus-EZY Manual Resuscitator Medical Recall Class II Hospital
(single-use pulmonary Device
resuscitator)
12/05/2016 Revolution CT (diagnostic x-ray Medical Recall for Class II Hospital
system) Device Product
Correction
12/05/2016 TnI-Ultra (Troponin) Assay, 100 Medical Recall for Class II Hospital
and 500 tests (used in the Device Product
determination of cardiac Correction
troponin). An in vitro diagnostic
11/05/2016 Cordis PRECISE PRO RX Nitinol Medical Recall Class I Hospital
Stent System (Carotid) Device
11/05/2016 HeartWare HVAD system Medical Hazard Alert Class I Hospital
Device
11/05/2016 Multiple Assay for Enzymatic Medical Recall for Class II Hospital
Creatinine, Cholesterol, Device Product
Triglyceride, Uric Acid, Lactate, Correction
Lipase. An in vitro diagnostic

Datei Levelvi
10/05/2016 RAPID Hp StAR Kit (used in the Medical Recall Class II Hospital
detection of H. pylori). An in vitro Device
10/05/2016 Volcano S5, S5i, CORE, CORE Medical Recall for Class I Hospital
Mobile Systems with software Device Product
versions v3.2x, v3.3, v3.4.1 Correction
(used to diagnose anatomical
defects of the heart or problems
associated with myocardial
infarction)
9/05/2016 Centurion FMS (Fluidics Medical Recall Class II Hospital
Management System) Pack Device
(used to control irrigation and
aspiration in the eye during
cataract surgery)
9/05/2016 Rifadin IV 600mg (Rifampicin Medicine Recall Class II Hospital
B.P. 600mg powder for I.V.
infusion and diluent)
9/05/2016 Threader Monorail and Threader Medical Recall for Class III Hospital
Over the Wire Micro-Dilatation Device Product
Catheters (used during Correction
angioplasty procedures)
6/05/2016 Ingenuity Core128 CT System Medical Recall for Class II Hospital
Device Product
Correction
6/05/2016 MobileDiagnost wDR 2, all Medical Recall for Class I Hospital
software versions affected Device Product
(diagnostic x-ray system) Correction
6/05/2016 SMR Glenosphere Impactor Medical Recall Class II Hospital
Device
5/05/2016 D-Vapor and D-Vapor 3000 Medical Recall for Class II Hospital
Vaporisers (used in connection Device Product
with Baxter Desflurane Agent Correction
and Bottles)
4/05/2016 Hydralyte Sports Lemon Lime Medicine Recall Class II Retail
600mL Bottle
3/05/2016 ADVIA Centaur XPT Systems. Medical Recall for Class II Hospital
3/05/2016 ADVIA Chemistry XPT System Medical Recall for Class II Hospital
with software versions 1.0.3 and Device Product
1.1. An in vitro diagnostic Correction
3/05/2016 Birmingham Hip Product Range Medical Hazard Alert Class II Hospital
Device
3/05/2016 Cortex Screw Ø 4.5mm, self- Medical Recall Class II Hospital
tapping, length 20mm, Pure Device
Titanium
3/05/2016 Xhibit Central Station (patient Medical Recall for Class I Hospital
monitoring system) Device Product
Correction
29/04/2016 ARCHITECT STAT High Medical Recall Class I Hospital
Sensitive Troponin-I Reagent Kit. Device
device (IVD)

Datei Levelvi
29/04/2016 Hamilton-G5 and Hamilton -S1 Medical Recall for Class II Hospital
Ventilators with software Device Product
versions v2.41, v2.42 and v2.50 Correction
29/04/2016 ID-Papain Assay. An in vitro Medical Recall Class II Hospital
29/04/2016 Maxi Air Blower Unit - Model Medical Recall for Class II Hospital
230V Device Product
Correction
29/04/2016 Novocastra Liquid Mouse Medical Recall for Class II Hospital
Monoclonal Antibody Calretinin. Device Product
device (IVD)
28/04/2016 ALUTEK and ALUXOID Medicine Product Defect Class II Hospital
Immunotherapy Products Alert
28/04/2016 Concerto & Basic Shower Medical Recall for Class II Hospital
Trolleys (used for assisted Device Product
hygiene care) Correction
28/04/2016 DX-D 600 Digital Radiography Medical Recall for Class II Hospital
System (general purpose x-ray Device Product
system) Correction
28/04/2016 Essure Permanent Birth Control Medical Recall for Class II Hospital
Device Product
Correction
28/04/2016 Groshong NXT PICC Connector Medical Recall for Class III Hospital
(used to repair the damaged Device Product
external segment of a catheter) Correction
28/04/2016 Image Suite Software Versions Medical Recall for Class II Hospital
3.0 and 4.0 Device Product
Correction
28/04/2016 Terumo CDI Blood Parameter Medical Recall for Class I Hospital
Monitoring System 500 Device Product
Correction
27/04/2016 GE Revolution CT Computed Medical Recall for Class II Hospital
Tomography X-ray systems Device Product
Correction
27/04/2016 LenSx Laser System with Medical Recall for Class II Hospital
Corneal Flap Capability (used to Device Product
perform corneal flaps in LASIK Correction
surgery or other treatment
involving the incision of the
cornea)
27/04/2016 Philips EPIQ Ultrasound System Medical Recall for Class II Hospital
Device Product
Correction
26/04/2016 G-scan Brio Magnetic Medical Recall for Class II Hospital
Resonance System Device Product
Correction
26/04/2016 ThinPrep 5000 Processor with Medical Recall for Class II Hospital
Autoloader Device Product
Correction
22/04/2016 Cardiosave Hybrid and Medical Recall for Class I Hospital
Cardiosave Rescue Intra-Aortic Device Product
Balloon Pumps (IABP) Correction

Datei Levelvi
22/04/2016 Catheters with Beacon Tip Medical Recall Class I Hospital
Technology Device
22/04/2016 CinchLock SS Knotless Anchor Medical Recall Class II Hospital
with Inserter (intended for the Device
fixation of soft tissue to bone)
22/04/2016 Dexamethasone Oral Solution Medicine Recall Class II Hospital
1mg/mL (used in the treatment of
mild to moderate croup in
paediatric patients)
22/04/2016 EnCor Probes (used for breast Medical Recall for Class II Hospital
biopsies) Device Product
Correction
22/04/2016 iLED 3/5, TruLight 3000/5000, Medical Recall for Class II Hospital
Helion, TruVidia SD, TruVidia Device Product
HD, VidiaPort Surgical Lighting, Correction
Camera and Monitoring Systems
21/04/2016 Capnostream 20p Patient Medical Recall Class II Hospital
Monitors - battery pack (used for Device
combined capnograph/pulse
oximeter monitor)
21/04/2016 Elecsys Estradiol Assay with Medical Recall for Class I Hospital
Fulvestrant. An in-vitro Device Product
21/04/2016 Given Imaging Bravo pH Medical Recall for Class II Hospital
monitoring systems Device Product
Correction
21/04/2016 Insulin-Like Growth Factor I Medical Recall for Class II Hospital
(IGF-I) Assay (Used on Immulite Device Product
and Immulite 1000 Systems). An Correction
(IVD)
21/04/2016 PF6 Tube Assembly (a Medical Recall Class II Hospital
component of the Peripheral Device
Vascular Infusion/Aspiration
Catheter or “PAD” catheter)
20/04/2016 Biosense Webster PENTARAY Medical Recall for Class II Hospital
NAV and PENTARAY NAV eco Device Product
Catheters (used for Correction
electrophysiological mapping of
the heart)
20/04/2016 DBL Vancomycin Hydrochloride Medicine Recall Class III Hospital
for Intravenous Injection Infusion
500mg, 500,000 I.U./vial
19/04/2016 Ingenuity Core using software Medical Recall for Class II Hospital
version 3.5.4 Device Product
Correction
19/04/2016 Lotus Valve System (a Medical Recall for Class I Hospital
transcatheter aortic valve Device Product
implantation (TAVI) system) Correction
19/04/2016 RAPIDQC Complete Solution Medical Recall Class II Hospital
Level 3. An in vitro diagnostic Device

Datei Levelvi
18/04/2016 Aperio eSlide Manager with Medical Recall for Class II Hospital
ImageScope, software versions Device Product
12.2.1, 12.2.2 and 12.3. An in Correction
(IVD)
18/04/2016 Lightspeed CT, Discovery Medical Recall for Class II Hospital
PET/CT (Computed tomography Device Product
x-ray and nuclear medicine Correction
gamma camera diagnostic
systems)
14/04/2016 American Surgical Company Medical Recall Class II Hospital
(ASC ) Neuro Sponges Device
14/04/2016 D-Vapor and D-Vapor 3000 Medical Recall for Class II Hospital
Vaporisers (used in connection Device Product
with Baxter Desflurane Agent Correction
and Bottles)
14/04/2016 IRISpec CA/CB/CC and IRISpec Medical Recall for Class II Hospital
CA/CB Control Kits (quality Device Product
control for the detection of Correction
Bilirubin). An in vitro diagnostic
14/04/2016 Military Trauma & Haemorrhage Medical Recall Class II Consumer
Wound Dressing, size 10 x 17cm Device
12/04/2016 Aquasil Easy Mix Putty (used for Medical Recall Class III Retail
taking impressions of teeth) Device
12/04/2016 CareLink Monitor and CareLink Medical Recall for Class II Hospital
Express Monitor Device Product
Correction
12/04/2016 VITROS 3600 Medical Recall for Class I Hospital
Immunodiagnostics System and Device Product
VITROS 5600 Integrated Correction
System, software version 3.2.2
and below. An in vitro diagnostic
11/04/2016 Cuff Controller with Clamp Medical Recall Class II Hospital
(monitors the cuff pressure of Device
tracheal tubes for intubated
patients)
11/04/2016 e.cam and all Symbia systems Medical Recall for Class II Hospital
with foresight detectors (Nuclear Device Product
medicine gamma camera Correction
systems)
11/04/2016 Fujifilm ED-530XT Medical Recall for Class II Hospital
Correction
11/04/2016 Mizuho General Purpose Medical Recall for Class II Hospital
Operating Table Device Product
Correction
8/04/2016 Aisys and Aisys CS2 Medical Recall for Class II Hospital
Anaesthesia machines with the Device Product
optional Vacuum Suction Correction
Function
8/04/2016 LifeCycle for Prenatal Screening, Medical Recall for Class II Hospital
Version 4.0 Revisions 2, 3 and 4. Device Product
device (IVD)

Datei Levelvi
8/04/2016 Papoose Infant Spine Medical Recall for Class II Hospital
Immobilisers Device Product
Correction
8/04/2016 UniCel (DxH 800/DxH 600/ DxH Medical Recall for Class III Hospital
Slidemaker Stainer) Coulter Device Product
Cellular Analysis Systems. An in Correction
(IVD)
8/04/2016 Vaxcel and Xcela PICC with Medical Recall Class II Hospital
PASV Valve Technology/Kits, Device
BioFlo PICC Triple Lumen with
Endexo and PASV Valve
Technology/Kits
7/04/2016 Hickman and Leonard Central Medical Recall for Class III Hospital
Venous Catheter Kits Device Product
Correction
7/04/2016 ID Anti-N and ID Anti-M/N. An in Medical Recall for Class II Hospital
(IVD) Correction
7/04/2016 ME DPHC 0001 deltastream HC, Medical Recall for Class II Hospital
230V Device Product
Correction
7/04/2016 Pentax ED-3490TK Video Medical Recall for Class II Hospital
Correction
6/04/2016 AutoSPECT Pro Reconstruction Medical Recall for Class II Hospital
application on Extended Device Product
Brilliance Workplace NM Correction
6/04/2016 Burinex Bumetanide 1mg tablet Medicine Recall Class III Retail
6/04/2016 Leksell Gammaknife Perfexion Medical Recall for Class I Hospital
and Leksell Gammaknife Icon Device Product
Correction
5/04/2016 10mm Direct Drive Clip Applier Medical Recall Class II Hospital
(Used for ligation of tubular Device
structures or vessels in
laparoscopic and general
surgical procedures)
5/04/2016 ARCHITECT Estradiol Reagent. Medical Recall for Class I Hospital
5/04/2016 CELL-DYN Emerald Cleaner. An Medical Recall Class II Hospital
(IVD)
5/04/2016 EZee-Nest Insert Cups used with Medical Recall for Class II Hospital
ADVIA Centaur CP. An in vitro Device Product
5/04/2016 Gene Amplification Reagent – Medical Recall Class II Hospital
Lynoamp BC. An in vitro Device
diagnostic medical device.
Testing Discs - Device
Ticarcillin/Clavulanic Acid (TIM85
Timetin). An in vitro diagnostic

Datei Levelvi
5/04/2016 Somatom Force with software Medical Recall for Class I Hospital
versions, VA50A and Device Product
VA50A_SP2 with paediatric Correction
kernel Hp38 (Computed
Tomography (CT) system)
4/04/2016 PneumoSure XL High Flow Medical Recall Class II Hospital
Insufflator (Used to create a Device
cavity by insufflating CO2 during
diagnostics and/or therapeutic
laparoscopy)
1/04/2016 AutoSPECT Pro Reconstruction Medical Recall for Class II Hospital
application on Intellispace Portal Device Product
software versions 5.0, 6.0 and Correction
7.0
1/04/2016 INTELEPACS Versions 4.5.1 to Medical Recall for Class II Hospital
4.12.1 Device Product
Correction
31/03/2016 Artis zee Systems with generator Medical Recall for Class II Hospital
A100Plus or Artis zeego Device Product
Systems with software version Correction
VC21B. (fluoroscopic
angiographic x-ray systems)
30/03/2016 Dimension Vista 500/ Dimension Medical Recall for Class II Hospital
Vista 1500 Intelligent Lab Device Product
Systems, software versions V. Correction
3.6.1 SP1 or V. 3.6.2. An in vitro
30/03/2016 T34L and NIKI T34 Ambulatory Medical Recall for Class II Hospital
syringe pumps Device Product
Correction
24/03/2016 Acuson 2000 ultrasound system Medical Recall for Class II Hospital
(with structural foam core). Device Product
Correction
24/03/2016 Acuson SC200 ultrasound Medical Recall for Class II Hospital
Correction
24/03/2016 ADVIA Chemistry Systems Medical Recall for Class II Hospital
(using Trinder and Trinder-like Device Product
assays). An in vitro diagnostic Correction
24/03/2016 Dimension and Dimension Vista Medical Recall for Class II Hospital
Clinical Chemistry Systems. An Device Product
(IVD)
24/03/2016 Fetch 2 Aspiration Catheter Medical Recall Class I Hospital
Device
24/03/2016 MobileDiagnost wDR Rel1 and 2 Medical Recall for Class II Hospital
(general purpose mobile digital Device Product
x-ray system) Correction
24/03/2016 TCAutomation System with Medical Recall for Class II Hospital
Thermo Scientific Recapper Device Product
(used with VITROS Automation Correction
Solutions). An in vitro diagnostic

Datei Levelvi
23/03/2016 Aisys CS2 and upgraded Aisys Medical Recall for Class I Hospital
anaesthesia devices (with Device Product
software version 10.X) Correction
23/03/2016 Brilliance CT and Ingenuity CT Medical Recall for Class III Hospital
with software versions v4.13 and Device Product
v4.1.4 (Computed tomography Correction
full-body x-ray system)
22/03/2016 Betamin 100mg tablets Medicine Recall Class II Consumer
(Thiamine Hydrochloride), Bottle
of 100 Tablets
22/03/2016 da Vinci Si and Xi Surgical Medical Recall for Class II Hospital
System - Touchpad Compact Device Product
Flashcards Correction
22/03/2016 Integre S Surgical frequency Medical Recall for Class II Hospital
doubled Nd YAG laser system Device Product
and Retinal Rejuvenation Correction
Therapy System (2RT)
22/03/2016 Omrix Pressure Regulators Medical Recall for Class II Hospital
Device Product
Correction
21/03/2016 Methotrexate Assay performed Medical Recall for Class II Hospital
on Syva Emit Methotrexate Device Product
Application (DVMTX.1) for the Correction
Dimension Vista System. An in
(IVD)
21/03/2016 Symbia E and e.cam collimator Medical Recall for Class II Hospital
Device Product
Correction
21/03/2016 Versant kPCR Molecular System Medical Recall for Class II Hospital
Sample Preparation. An in vitro Device Product
18/03/2016 Allura Xper with software release Medical Recall for Class II Hospital
FD R8.1.16 Device Product
Correction
18/03/2016 Oxoid Nitrocefin (+ Medical Recall Class II Hospital
Reconstitution Fluid) Device
16/03/2016 Neuroform Atlas Stent System Medical Recall for Class II Hospital
Device Product
Correction
15/03/2016 CARDIOSAVE Hybrid and Medical Recall for Class I Hospital
Rescue Intra-aortic Balloon Device Product
Pumps (IABP) Correction
15/03/2016 Hamilton Medical G5 / S1 Medical Recall for Class II Hospital
Ventilator with software version Device Product
V2.42 Correction
15/03/2016 ORTHO VISION Analyser, Medical Recall for Class II Hospital
software version 2.12.6 & below Device Product
and ORTHO VISION Max Correction
Analyser, software version
2.12.10 (for ORTHO BioVue
Cassettes). An in vitro diagnostic

Datei Levelvi
15/03/2016 Renasys GO External Power Medical Recall Class II Hospital
Supply Units supplied with Device
Renasys GO NPWT Pumps
(Negative Pressure Wound
Therapy System)
11/03/2016 ClaveGuard Diathermy Pencil Medical Recall Class II Hospital
Device
11/03/2016 Dymista 125/50 Nasal Spray Medicine Recall Class III Retail
17ml
11/03/2016 TOPAZ MicroDebrider Wand Medical Recall Class II Hospital
(used for ablation and Device
microdebridment in the tendons
of the ankles, knees and
shoulders)
11/03/2016 Virage Occipital-Cervical- Medical Recall for Class II Hospital
Thoracic (OCT) Spinal Fixation Device Product
System - Closure Caps (used to Correction
stabilise support or correct
alignment of spinal vertebrae)
10/03/2016 Cios Alpha Medical Recall for Class II Hospital
Device Product
Correction
10/03/2016 e.cam system Medical Recall for Class II Hospital
Device Product
Correction
9/03/2016 Drill Sleeve 9.0/2.8, L 191 mm, Medical Recall Class II Hospital
f/AFN Device
9/03/2016 HemoCue Glucose 201 RT Medical Recall for Class II Hospital
Microcuvettes (used with Device Product
HemoCue Glucose 201 RT and Correction
HemoCue Glucose 201 RT DM
analysers). An in vitro diagnostic
9/03/2016 Hydralyte Sports Berry, Oral Medicine Recall Class II Retail
Liquid 600mL
9/03/2016 Syngo X-Workplace with Medical Recall for Class I Hospital
software version VD10E (image Device Product
processing workstation used with Correction
x-ray based diagnostic imaging
system)
8/03/2016 AvantGuard 1600 Li160A0 Medical Recall for Class III Hospital
Device Product
Correction
8/03/2016 Cranial Screw PlusDrive ø 1.6 Medical Recall Class II Hospital
mm, Self-Drilling, L 3mm (part of Device
the Low Profile Neuro System
intended for use in selective
trauma of the midface and
craniofacial skeleton)
8/03/2016 NIM-ECLIPSE Notebook Medical Recall for Class III Hospital
Computer, NCCPU-E4 Device Product
Correction
8/03/2016 Universal Clamp System and Medical Recall for Class II Hospital
UniWallis System (used during Device Product
spinal cord surgery) Correction

Datei Levelvi
8/03/2016 VERION Reference Unit (Vision Medical Recall for Class II Hospital
Planner) - used with the Alcon Device Product
LenSx Laser System (Surgery Correction
planning system for ophthalmic
surgery)
4/03/2016 AXIOM Artis, Artis zee and Artis Medical Recall for Class II Hospital
Q/Q.zen (fluoroscopic Device Product
angiographic x-ray system) Correction
4/03/2016 Dexcom G4 PLATINUM and Medical Recall for Class II Consumer
Dexcom G5 Mobile receiver Device Product
(Continuous Glucose Monitoring Correction
Device).
4/03/2016 Freelite Human Kappa Integra Medical Recall for Class II Hospital
Kit. An in vitro diagnostic medical Device Product
4/03/2016 Mums The One One Step hCG Medical Recall Class II Consumer
Urine Pregnancy Test Device
4/03/2016 STERIS Quick Connects (used Medical Recall for Class III Hospital
with the Steris System 1 Express Device Product
and System 1 Plus sterilisers) Correction
4/03/2016 WIZARD2 Gamma Counters. An Medical Recall for Class II Hospital
(IVD) Correction
3/03/2016 ARCTICGEL Pads (used with Medical Recall Class II Hospital
the Arctic Sun Temperature Device
Management System)
3/03/2016 Dimension Vista Chemistry 3 Medical Recall for Class II Hospital
Calibrator. An in vitro diagnostic Device Product
3/03/2016 Locking Screw Stardrive 1.5 mm Medical Recall Class II Hospital
and Cortex Screw Stardrive Device
1.5mm
3/03/2016 SIGNA Pioneer MRI System Medical Recall for Class II Hospital
Device Product
Correction
1/03/2016 B.R.A.H.M.S Free BhCG Kryptor Medical Recall for Class II Hospital
Kit. An in vitro diagnostic medical Device Product
1/03/2016 Horizon Medical Imaging (HMI) Medical Recall for Class II Hospital
product versions 4.6.1 up to and Device Product
including 11.9 and McKesson Correction
Radiology (MR) 12.0 and 12.1.1
1/03/2016 i-STAT troponin I Assay Medical Recall for Class III Hospital
Cartridges (cTnl). An in vitro Device Product
1/03/2016 ORTHO VISION Analyzer for Medical Recall for Class I Hospital
ORTHO BioVue Cassettes, Device Product
software version 2.12.6 and Correction
below. An in vitro diagnostic
1/03/2016 Safe-T-Vue 6 and Safe-T-Vue10 Medical Recall for Class II Hospital
Temperature Indicators (used to Device Product
monitor the temperature of blood Correction
bags during transit)

Datei Levelvi
1/03/2016 USB Communication Data Loss Medical Recall for Class II Hospital
– Handheld Base Unit and Accu- Device Product
Chek Inform II Base Unit Correction
29/02/2016 VITROS 5600 Integrated Medical Recall for Class II Hospital
29/02/2016 VITROS Immunodiagnostic Medical Recall Class II Hospital
Products Total B-hCG II Reagent Device
Packs & Calibrators (used with
ECi/ECiQ, 3600
Immunodiagnostic Systems and
5600 Integrated Systems). An in
(IVD)
26/02/2016 Blood Urea Nitrogen (BUN) Flex Medical Recall Class II Hospital
Reagent Cartridge (used with Device
Dimension Vista System). An in
(IVD)
Antenna (short, standard & long) Device
with Thermosphere Technology
(used with microwave generator
for coagulation of soft tissue)
26/02/2016 GENTECH Generator Medicine Recall for Class II Hospital
(99Mo/99mTc Sterile Generator) Product
Correction
26/02/2016 Medtronic Reveal LINQ Medical Hazard Alert Class II Hospital
Insertable Cardiac Monitor (ICM) Device
26/02/2016 QuikRead go wrCRP and Medical Recall Class II Hospital
QuikRead go wrCRP+Hb Device
25/02/2016 IntelePACS InteleViewer Medical Recall for Class II Hospital
software version 4.11.1 P144 Device Product
(Radiology picture archiving and Correction
24/02/2016 ARROW Intra-Aortic Balloon Medical Recall Class I Hospital
Catheter and Percutaneous Device
Insertion Kits
24/02/2016 Coban 2 Compression Layer Medical Recall Class II Hospital
(active support bandage) Device
24/02/2016 Coban 2 Lite Compression Layer Medical Recall Class III Retail
(active support bandage) Device
24/02/2016 Renitec Plus (enalapril Medicine Recall Class II Retail
maleate/hydrochlorothiazide )
20/6mg tablets
24/02/2016 Verso Shoulder Forked Retractor Medical Recall Class II Hospital
(Comprehensive Instrumentation Device
(2 Prong Retractor))
23/02/2016 175 cartons of GONAL-F Medicine Recall Class II Retail
follitropin alfa (rch) and 10
cartons of CETROTIDE
cetrorelix
23/02/2016 Conceiveplease One Step HCG Medical Recall Class II Consumer
Urine Pregnancy test Device

Datei Levelvi
23/02/2016 ITD VESA 75/100 Adaptation Medical Recall for Class II Hospital
with Rotation (Articulating Arm Device Product
on Endoscope Trolley) Correction
23/02/2016 Maxagra 300 mg Capsules Medicine Recall Class II Consumer
22/02/2016 ADVIA Centaur Systems Medical Recall for Class II Hospital
Calibrator E (Used with Advia Device Product
Centaur, Centaur XP, Centaur Correction
XPT Systems). An in vitro
22/02/2016 iMDsoft MetaVision ICU (MV- Medical Recall for Class III Hospital
ICU), Version 5.47.4622 Device Product
Correction
22/02/2016 Paracetamol Osteo-Tab, Medicine Recall Class II Retail
paracetamol 665 mg modified
release tablet bottle (no other
paracetamol brands are
impacted)
19/02/2016 Boston Scientific Medical Recall for Class II Hospital
Urogynaecological Surgical Device Product
Meshes Correction
19/02/2016 Sangofix set with hand pump Medical Recall Class II Hospital
(Blood/Solution Transfusion Set) Device
19/02/2016 Spiggle & Theis ENT sinus Medical Recall Class II Hospital
single-use suction tubes (used Device
for paranasal sinus suction)
18/02/2016 cobas p 512 pre-analytical Medical Recall for Class II Hospital
system. An in vitro diagnostic Device Product
18/02/2016 Nuelin SR 250 (theophylline Medicine Recall Class II Retail
250mg) tablets, Bottle 100s
17/02/2016 Cardiopulmonary Bypass Packs Medical Recall for Class II Hospital
containing Terumo CDI H/S Device Product
Cuvettes used with the CDI Correction
Blood Parameter Monitoring
System 500
17/02/2016 FGD (Fludeoxyglucose [18F]) Medicine Recall Class II Hospital
Injection
17/02/2016 Helioseal Clear, 1.25g syringes Medical Recall Class II Retail
Device
17/02/2016 Powerheart G3 Defibrillation Medical Recall Class II Retail
Electrodes (used in Powerheart Device
G3 9300A, 9300E, 9300P,
9390A, and 9390E Automatic
External Defibrillator (AEDs))
16/02/2016 MitraClip System (Product Medical Recall for Class I Hospital
Number # MSK02ST) containing Device Product
the Clip Delivery System (Part Correction
number # CDS02ST) and the
Steerable Guide Catheter (Part
number # SGC01ST)
16/02/2016 RayStation 3.0, 3.5, 4.0, 4.5 and Medical Recall for Class II Hospital
4.7 (Radiation therapy treatment Device Product

Datei Levelvi
16/02/2016 Syntometrine Injection 1 mL Medicine Recall Class III Wholesale
Ampoule
15/02/2016 3.0T GEMflex Coil used with GE Medical Recall for Class II Hospital
Healthcare 3.0T Scanners (used Device Product
to transmit and receive RF Correction
pulses for diagnostic MRI
procedures)
15/02/2016 Berichrom Antithrombin III Kits. Medical Recall Class III Hospital
device (IVD)
15/02/2016 Sureclip and Sureclip Plus Medical Recall Class II Hospital
Haemostasis Clips Device
(Gastrointestinal endotherapy
clip applier)
11/02/2016 Depuy Synthes Universal Battery Medical Recall Class II Hospital
Charger II (UBC II) Device
11/02/2016 Klikfit CT Syringe with QFT and Medical Recall Class II Hospital
75cm Extension tube Device
11/02/2016 Leica M525 OH4 and M720 OH5 Medical Recall for Class II Hospital
Surgical Microscope Stands with Device Product
400W Illumination Correction
11/02/2016 Merifluor EBV VCA IgM IFA (an Medical Recall Class III Hospital
Immunofluorescence Test for the Device
Detection of Antibodies). An in
(IVD)
11/02/2016 Rotor Yokes (used in Allegra X-5 Medical Recall for Class II Hospital
Centrifuge). An in vitro diagnostic Device Product
the Optional PS500 Installed Device Product
Correction
10/02/2016 Ondansetron Tablets - Medicine Recall Class III Retail
Ondansetron-DRLA and
Ondansetron-SZ 4mg and 8mg
10/02/2016 Terumo CDI H/S Cuvette Medical Recall for Class II Hospital
Device Product
Correction
10/02/2016 Trinity Acetabular Shell Medical Recall Class II Hospital
Device
10/02/2016 VIDAS TOXO IgM Assay (used Medical Recall for Class II Hospital
for the detection of Device Product
toxoplasmosis antibodies). An in Correction
(IVD)
9/02/2016 Colleague P1.7 CXE Single Medical Recall for Class II Hospital
Channel Pump and Colleague Device Product
P1.7 CXE Triple Channel Pump Correction
(Infusion Pump)
9/02/2016 Veletri Consumables Kit - Medical Recall Class II Consumer
Infusion administration set Device
containing B. Braun Water for
Injections

Datei Levelvi
8/02/2016 COULTER ReticPrep Reagent Medical Recall for Class III Hospital
Kit (used for reticulocyte Device Product
counting). An in vitro diagnostic Correction
8/02/2016 DVR ePAKs Medical Recall Class II Hospital
Device
8/02/2016 Liquichek Specialty Medical Recall for Class II Hospital
Immunoassay Controls. An in Device Product
(IVD)
8/02/2016 PRN 50-M+ Digital Writer Medical Recall for Class II Hospital
Device Product
Correction
4/02/2016 Carestation 620 A1, 650 A1, and Medical Recall for Class I Hospital
650c A1 Anaesthesia devices Device Product
and service kits Correction
4/02/2016 Glidescope Titanium Single-Use Medical Recall Class I Hospital
Video Laryngoscope Blades Device
4/02/2016 Surgical Clipper Charger Medical Recall Class II Hospital
Device
3/02/2016 3M ESPE Adper Single Bond 2 Medical Recall Class III Retail
Device
3/02/2016 Clobex clobetasol propionate Medicine Recall for Class II Retail
500 microgram/mL Shampoo Product
Application Bottle 125mL Correction
3/02/2016 D-10 Rack Loader. An in vitro Medical Recall for Class II Hospital
Correction
3/02/2016 iChemVelocity Automated Urine Medical Recall Class II Hospital
Chemistry System using Device
iChemVelocity Urine Chemistry
Strips. An in vitro diagnostic
device (IVD)
3/02/2016 Kangaroo Polyurethane Feeding Medical Recall Class II Hospital
Tube, Radiopaque Line, Safe Device
Enteral Connections 6.5 Fr/Ch
(2.2 mm) x 36" (91 cm)
3/02/2016 Puritan Bennett 980 Series Medical Recall for Class I Hospital
Ventilator System PB980 Device Product
Correction
3/02/2016 Terumo CVS CDI H/S Cuvette Medical Recall for Class II Hospital
provided within the Medtronic Device Product
Perfusion Tubing Pack Correction
2/02/2016 Anti-Jk (Jk1). Medical Recall Class I Hospital
Device
2/02/2016 HomeChoice Pro Automated PD Medical Recall for Class III Consumer
System devices Device Product
Correction
2/02/2016 Water for Injections 100 mL Medicine Recall Class II Hospital
bottle (for parenteral use)
1/02/2016 Panocell 16 and Panocell 20. An Medical Recall for Class III Hospital
(IVD). Correction

Datei Levelvi
28/01/2016 Acetaminophen (Paracetamol) Medical Recall for Class II Hospital
Reagent (used with L3K Assay in Device Product
conjunction with the Architect Correction
cSystem Analyser). An in vitro
28/01/2016 Endobon Xenograft Granules Medical Recall Class II Retail
Device
28/01/2016 PyroTitan Humeral Resurfacing Medical Recall Class II Hospital
Arthroplasty Shapers Device
28/01/2016 Super Arrow-Flex Percutaneous Medical Recall Class II Hospital
Sheath Introducer Set Device
28/01/2016 Trilogy dual prescription Medical Recall for Class I Consumer
ventilators with software versions Device Product
13.2.04, 13.2.05, 14.0.00, and Correction
14.1.01
27/01/2016 TJF-Q180V Duodenoscope Medical Recall for Class II Hospital
Device Product
Correction
25/01/2016 DIAMOX (acetazolamide) 250mg Medicine Recall Class II Consumer
tablet bottle
25/01/2016 LCP Distal Tibial Plates 3.5 Medical Recall Class II Hospital
anterolateral, left, 9 holes, length Device
132mm Stainless Steel Sterile
22/01/2016 Beaver 4.0mm Banana Blade Medical Recall Class II Hospital
Device
21/01/2016 Liko Universal SlingBar 350, Medical Recall for Class II Consumer
SlingBar 450 and SlingBar 600 Device Product
(used with Golvo, Uno, LikoLight, Correction
Likorall, Multirall and Viking
XS/S/M/L mobile patient lifts)
20/01/2016 Hexad 12-Lead ECG Monitoring Medical Recall for Class I Hospital
derivation with Philips IntelliVue Device Product
Patient Monitors, software Correction
versions K.21.54 or L.00.96
18/01/2016 Astral Ventilators - ResMed Medical Recall for Class II Consumer
Astral 100 & Astral 150 with Device Product
SR1.1 software (SX544-0301) Correction
18/01/2016 Bond Ready-to-Use Primary Medical Recall Class II Hospital
Antibody and Probe kits used Device
with Bond Polymer Refine
Detection Kit. An in vitro
18/01/2016 BrightView X/XCT/XCT Upgrade Medical Recall for Class II Hospital
Device Product
Correction
18/01/2016 Curlin 6000 and Painsmart IOD Medical Recall for Class II Hospital
Ambulatory Infusion Pumps Device Product
Correction
18/01/2016 PS900 Power Module supplied Medical Recall for Class III Hospital
with 12 Lead ECG Interp. Device Product
210mm Basic Monitors Correction

Datei Levelvi
15/01/2016 ADVIA Centaur Systems, Medical Recall for Class I Hospital
Dimension Vista Systems & Device Product
IMMULITE Systems Estradiol Correction
Assays
15/01/2016 Brain Metastases v1.0.0 and Medical Recall for Class I Hospital
Adaptive Hybrid Surgery Device Product
Analysis (AHSA) v1.0.0 Correction
15/01/2016 Eclipse Treatment Planning Medical Recall for Class I Hospital
System v 11, 13.0, 13.5 and 13.6 Device Product
using Pencil Beam Convolution Correction
(PBC) Algorithm 11.0.31
15/01/2016 Flocare Transition Giving Sets Medical Recall for Class II Consumer
(Enteral feeding tube) Device Product
Correction
15/01/2016 ImmunoCAP Specific IgG/IgG4 Medical Recall for Class III Hospital
i1 Control H. An in vitro Device Product
diagnostic device (IVD) Correction
15/01/2016 Ingenuity CT/Core/Core128/Flex, Medical Recall for Class II Hospital
Brilliance CT Big Bore /iCT/iCT Device Product
SP Systems Correction
14/01/2016 Central Venous Catheter and Medical Recall Class I Hospital
Pressure Monitoring Sets Device
14/01/2016 Saline 0.9% in 240ml Medicine Recall Class I Hospital
elastomeric device
13/01/2016 Rayner Intraocular Lenses - Medical Hazard Alert Class I Hospital
Sulcoflex Aspheric 653L, Device
Sulcoflex Torie 653T, C-flex
Aspheric 970C, Superflex
Aspheric 920H, Sulcoflex
Aspherie 653L, T-flex Aspheric
623T
12/01/2016 Aespire 7900, Aespire View, Medical Recall for Class II Hospital
Aestiva 7900, Aestiva MRI, Device Product
Aisys, Aisys CS2, Avance, and Correction
Avance CS2 Anesthesia devices
installed from April 20, 2015
through October 2015. Service
kits containing the ventilator
Drive Gas Check Valve shipped
from April 20, 2015 through
October 2015 are also affected
12/01/2016 Steris Amsco Warming Cabinet Medical Recall for Class III Hospital
Device Product
Correction
8/01/2016 BCS / BCS XP Automated Blood Medical Recall for Class II Hospital
Coagulation Analyser with Dade Device Product
Innovin .An in vitro diagnostic Correction
device (IVD)
8/01/2016 Integra Camino Intracranial Medical Recall for Class II Hospital
Pressure (ICP) Monitor and the Device Product
Integra Licox PtO2 and Correction
Temperature Monitor
8/01/2016 One Step HCG Urine Pregnancy Medical Recall Class II Retail
Test. An in vitro diagnostic Device

Datei Levelvi
7/01/2016 Extraction Screw for PFNA Blade Medical Recall Class I Hospital
Device
7/01/2016 HeartWare HVAD Controller AC Medical Hazard Alert Class I Hospital
Adapter and HeartWare HVAD Device
Battery
7/01/2016 INNOVANCE PFA P2Y. An in Medical Recall for Class III Hospital
vitro diagnostic device (IVD) Device Product
Correction
7/01/2016 VITROS Chemistry System. An Medical Recall for Class II Hospital
(IVD) Correction
6/01/2016 ADVIA Centaur PSA 100 test kit Medical Recall for Class III Hospital
and 500 test kit. An in vitro Device Product
6/01/2016 AQURE data management Medical Recall for Class II Hospital
system Device Product
Correction
6/01/2016 Cook Beacon Tip Angiography Medical Recall Class I Hospital
Catheters Device
5/01/2016 EliA SmDP Well Medical Recall Class II Hospital
Device
4/01/2016 Guide Wires and K-Wires for T2 Medical Recall Class II Hospital
and Gamma Nailing Systems Device
4/01/2016 Mavig Monitor suspension arms Medical Recall for Class II Hospital
manufactured before January Device Product
2009 (used with x-ray Correction
fluoroscopic imaging systems)
4/01/2016 Optima XR200amx, Optima Medical Recall for Class II Hospital
XR220amx and Brivo XR285amx Device Product
X-ray imaging systems Correction
24/12/2015 API ZYM B. An in vitro diagnostic Medical Recall for Class II Hospital
medical device (IVD) Device Product
Correction
24/12/2015 da Vinci Xi instrument & Medical Recall for Class II Hospital
accessories Device Product
Correction
24/12/2015 PFNA Nails (used during internal Medical Recall Class II Hospital
fixation surgery) Device
24/12/2015 Syner-Kinase Urokinase powder Medicine Recall Class II Hospital
for solution for injection or
infusion,10,000 IU vial (used for
lysis of blood clots in cannulas)
24/12/2015 TruLight 3000, TruLight 5000, Medical Recall for Class II Hospital
iLED 3, iLED 5 and TruVidia Device Product
Lighting and Video Systems Correction
24/12/2015 VariAx 2 3.5 mm screws Medical Recall for Class II Hospital
Device Product
Correction
23/12/2015 Coulter S-CAL Calibrator Kits Medical Recall for Class III Hospital
used on the Unicel DxH 800, Device Product
DxH 600, LH 750 and LH 780 Correction
Systems.

Datei Levelvi
23/12/2015 Oxylog Transport Ventilator Medical Recall for Class I Hospital
Device Product
Correction
22/12/2015 2-Way Foley Catheters and 2- Medical Recall for Class II Hospital
Way Council Tip Foley Catheters Device Product
(used for urinary drainage) Correction
22/12/2015 96 Deep Well Plate 2mL (used Medical Recall Class II Hospital
on the VERSANT kPCR Sample Device
Preparation and Tissue
Preparation System)
22/12/2015 All Magnetom MRI systems with Medical Recall for Class II Hospital
superconductive magnets Device Product
Correction
22/12/2015 Ambu AuraGain Single Use Medical Recall Class II Hospital
Laryngeal Mask – Sterile Device
22/12/2015 Dengue NS1 Ag Strip Medical Recall Class II Hospital
Device
22/12/2015 Maxolon Metoclopramide 10mg Medicine Recall Class II Retail
Tablets, Blister pack 100s
22/12/2015 VerifyNow Aspirin Test Kit Medical Recall Class II Hospital
Device
21/12/2015 All Giraffe Carestation Beds Medical Recall for Class I Hospital
shipped between 18 September Device Product
2015 and 1 November 2015 Correction
21/12/2015 BD Vacutainer Heparin Tube. n Medical Recall Class II Hospital
(IVD)
21/12/2015 Samarys Peek Anterior Cervical Medical Hazard Alert Class I Hospital
Cage Device
21/12/2015 TCM CombiM module (used with Medical Recall Class II Hospital
Radiometer Transcutaneous Device
Monitors)
18/12/2015 Synream Medullary Reamer Medical Recall Class II Hospital
Head Size 13.5mm Device
17/12/2015 Reflotron Uric Acid (used with Medical Recall Class II Hospital
Reflotron Plus & Reflotron Sprint Device
Single test chemistry systems)
device (IVD)
16/12/2015 IntelliVie Information Centre Medical Recall for Class I Hospital
(PIIC) iX (centralised patient Device Product
monitor) Correction
16/12/2015 Kirschner Wire 1.6 mm, with drill Medical Recall for Class III Hospital
tip, length 200 mm Device Product
Correction
16/12/2015 miraDry System (used for the Medical Recall for Class II Hospital
treatment of primary axillary Device Product
hyperhidrosis) Correction
15/12/2015 Arcadophta SARL– Arcotane 5ml Medical Recall Class I Hospital
Device
15/12/2015 Hypochlorite 1% Solution & Medical Recall Class III Retail
Hypochlor 1% Solution Device

Datei Levelvi
15/12/2015 STALORAL and PHOSTAL Medical Recall Class I Consumer
Device
11/12/2015 BladderScan BVI 9600 with Medical Recall for Class I Hospital
AortaScan mode portable Device Product
ultrasound instrument Correction
11/12/2015 Genotropin 5 mg and 12 mg Medicine Product Defect Class III Retail
GoQuick Pre-filled Pens Alert
10/12/2015 Gynecare Thermachoice III Medical Recall Class II Hospital
Thermal Balloon Ablation Device
Silicone Catheter
10/12/2015 MediRedi Fistula Packs Medical Recall Class II Hospital
Device
10/12/2015 MOSAIQ version 2.5 and above - Medical Recall for Class II Hospital
Medical Oncology only Device Product
Correction
10/12/2015 PFN/PFNA Insertion Handle Medical Recall Class II Hospital
(used for the insertion of Device
Proximal Femur Nail during
internal fixation surgery)
9/12/2015 ADVIA Centaur XPT System, Medical Recall for Class II Hospital
with software versions V1.0.1, Device Product
V1.0.2 and V1.0.3 Correction
9/12/2015 Multiple dental abutment Medical Recall Class II Retail
products and their accessories. Device
9/12/2015 Sysmex XN and XN-L Series - Medical Recall for Class III Hospital
All Sysmex XN analysers Device Product
versions 16 to 19 Correction
9/12/2015 Unicel DxH 800, SMS and 600 Medical Recall for Class II Hospital
systems, with software versions Device Product
3.0.2.0 and 1.1.1.0. An in vitro Correction
8/12/2015 Polymer Refine Red Detection Medical Recall Class II Hospital
(used for testing and Device
identification of neoplasm). An in
(IVD)
8/12/2015 Titanium Fluted Stem Extender Medical Recall Class III Hospital
Device
7/12/2015 Absorb Bioresorbable Vascular Medical Recall for Class II Hospital
Scaffold (BVS) System Device Product
(Bioresorbable balloon Correction
expandable scaffold with
bioresorbable polymeric drug
coating mounted on a balloon
dilatation catheter)
7/12/2015 ACUITY Pro 9 Fr Guide Catheter Medical Recall Class II Hospital
Device
7/12/2015 Bayer Source Administration Medical Recall Class II Hospital
Sets (SAS) used with the Device
Medrad Intego PET Infusion
System [Catalogue Number INT
CSS]

Datei Levelvi
7/12/2015 ENA RELISA Single Well Screen Medical Recall Class II Hospital
(576 well) Kit. An in vitro Device
7/12/2015 Endo GIA Ultra Universal Stapler Medical Recall Class II Hospital
Handles (Short, Standard & XL Device
versions)
7/12/2015 Shape Arm Kit Left and Shape Medical Recall for Class I Hospital
Arm Kit Right Device Product
(Mounting/positioning system for Correction
flat panel monitors)
7/12/2015 Switch Point Infinity 3 (Operating Medical Recall for Class III Hospital
Room Management System) Device Product
Correction
3/12/2015 Opti-Mist Nebuliser / Nebuliser Medical Recall Class II Hospital
Mask Products Device
Testing Disc QD15 Quinupristin / Device
Dalfopristin, CT1644B
2/12/2015 300mL Canister (with Gel) for Medical Recall Class II Hospital
use with the ActiV.A.C. Therapy Device
System
2/12/2015 Birmingham Hip Modular Head Medical Hazard Alert Class II Hospital
(BHMH) - Monoblock version Device
2/12/2015 Etest PIPTAZO PTC 256 (used Medical Recall Class I Hospital
for testing of Enterobacteria Device
strains). An in vitro diagnostic
2/12/2015 Fresnius Medical Care (FME) Medical Recall Class II Hospital
Dialysis Fistula Pack 5 and Device
Safety AVF Needle - Fixed Wing
2/12/2015 MediRedi A.V. Fistula Pack Medical Recall Class II Hospital
Device
2/12/2015 Sapphire Multi-Therapy and Medical Recall for Class II Hospital
Sapphire Epidural Pumps with Device Product
software versions 11.00 and Correction
below
1/12/2015 syngo X-Workplace with Medical Recall for Class II Hospital
software VD10E and tabcard Device Product
”4D” Correction
30/11/2015 A.L.P.S. 4.0mm Cancellous Medical Hazard Alert Class II Hospital
Locking Screws (non-sterile) Device
30/11/2015 ADVIA Chemistry Halogen Lamp Medical Recall for Class III Hospital
Device Product
Correction
27/11/2015 Brainlab Brain Metastases v1.0.0 Medical Recall for Class I Hospital
and Adaptive Hybrid Surgery Device Product
Analysis v1.0.0 Correction
27/11/2015 Careline Colostrum 820mg Medicine Recall Class III Retail
chewable tablets 200's and 400's
with expiry dates of 10/2016,
04/2017 and 09/2017

Datei Levelvi
27/11/2015 Ingenuity CT, Ingenuity Core, Medical Recall for Class III Hospital
Ingenuity Core128, Brilliance 64, Device Product
Brilliance iCT SP, Brilliance iCT Correction
systems with software versions
4.1.2, 4.1.3 and 4.1.4
27/11/2015 Nebulisers / Nebuliser Mask Medical Recall Class II Hospital
Products Device
26/11/2015 IntellaTip MiFi XP Asymmetric Medical Recall Class I Hospital
(N4) Curve Temperature Device
Ablation Catheters
the Optional PS500 battery Device Product
Installed Correction
25/11/2015 Karma Wheelchairs Medical Recall for Class II Hospital
Device Product
Correction
24/11/2015 Abtectcell III 0.8% and Abtectcell Medical Recall Class I Hospital
III 0.8% Bulk Pack. An in vitro Device
24/11/2015 AHG Control Cells 3%. An in Medical Recall Class II Hospital
(IVD)
23/11/2015 Artis systems with large display Medical Recall for Class II Hospital
module Device Product
Correction
23/11/2015 ENDOEYE Video Telescope Medical Recall for Class I Hospital
Device Product
Correction
Testing Disc for Penicillin G (P1). Device
device (IVD)
20/11/2015 A.V. Fistula sets for Medical Recall Class II Hospital
Haemodialysis - Safety AVF Device
Needle fixed wing
20/11/2015 VITROS 4600 Chemistry System Medical Recall for Class III Hospital
and VITROS 5,1 FS Chemistry Device Product
20/11/2015 Xper Flex Cardio Patient Medical Recall for Class II Hospital
Monitoring System Device Product
Correction
19/11/2015 Non Buffered Formalin. An in Medical Recall Class III Hospital
(IVD)
18/11/2015 ADVIA Centaur and ADVIA Medical Recall for Class II Hospital
Centaur XP Device Product
Correction
17/11/2015 Allura Xper, Allura Clarity & Medical Recall for Class I Hospital
Integris Device Product
Correction
17/11/2015 AU480, AU680, AU5800 Medical Recall for Class III Hospital
Chemistry Analysers. An in vitro Device Product

Datei Levelvi
17/11/2015 Bard Arctic Sun 5000 Medical Recall for Class II Hospital
Temperature Management Device Product
System Correction
17/11/2015 Dimension Integrated Chemistry Medical Recall for Class II Hospital
Systems. Device Product
Correction
17/11/2015 Two and three stage I.V. Poles Medical Recall for Class II Hospital
(used as an optional accessory Device Product
to a stretcher) Correction
16/11/2015 artus C. trachomatis Plus kits Medical Recall for Class II Hospital
Device Product
Correction
16/11/2015 ECG Electrode SKINTACT W-60 Medical Recall Class III Hospital
Device
16/11/2015 HemoCue HbA1c 501 Test Medical Recall Class III Hospital
Cartridge. An in vitro diagnostic Device
16/11/2015 Provide Protection Caps and Medical Recall Class II Retail
Provide Impression Copings Device
16/11/2015 Various surgical instruments Medical Recall for Class I Hospital
actuated by the da Vinci Si Device Product
Single Site Grip Release Correction
mechanism
13/11/2015 Allura Xper and Allura Clarity - Medical Recall for Class II Hospital
software releases 1.2.7, or 2.0.6, Device Product
or 7.2.x where x<8 or 7.6.x or Correction
7.8.x or 8.1.x where x< 16 or
8.2.x where x<16
13/11/2015 BARRIER Easywarm (Active Self Medical Recall for Class III Hospital
Warming Blanket) and BARRIER Device Product
Easywarm+ (Flexible Active Self Correction
Warming Blanket)
13/11/2015 Compounded Fentanyl and/or Medicine Recall Class II Hospital
Fentanyl Bupivicaine
combinations stored in Becton-
Dickinson Syringes 3ml or 10ml
Plastipak Syringes
13/11/2015 InSync III Cardiac Medical Hazard Alert Class I Hospital
Resynchronisation Therapy Device
Pacemakers (CRT-P)
13/11/2015 VITROS 3600 and 5600 Medical Recall for Class II Hospital
Systems using Software Version Device Product
3.2 and Below. An in vitro Correction
12/11/2015 ECG Electrode Medical Recall Class II Hospital
Device
12/11/2015 Lymph-flo Injection Composite Medicine Recall Class III Hospital
Pack (Technetium99m-ATC
(Tc99m-ATC))
12/11/2015 Screw Inserter for TFN- Medical Recall Class II Hospital
Advanced (TFNA) Proximal Device
Femoral Nailing System
11/11/2015 Arceole C3F8 and SF6 Medical Recall Class I Hospital
Device

Datei Levelvi
11/11/2015 Tina-quant Albumin. An in vitro Medical Recall Class III Hospital
10/11/2015 Attachment for Acetabular and Medical Recall Class I Hospital
Medullary Reaming (used with Device
the Compact Air Drive II, an air-
driven power tool for use in
traumatology, endoprosthetics
and spinal column surgery)
10/11/2015 DGDE DirectGuideTM Drill Medical Recall Class II Retail
Extender and kits containing the Device
DGDE Drill Extender
Testing Disc Cefoxitin. An in vitro Device
9/11/2015 Bard 100% Latex-Free Urinary Medical Recall Class II Hospital
Drainage Bag with Anti-Reflux Device
Chamber and Bard EZ-Lok
9/11/2015 ichem VELOCITY Urine Medical Recall Class II Hospital
Chemistry Strips. An in vitro Device
9/11/2015 LeMaitre Single Lumen Medical Recall Class II Hospital
Embolectomy Catheter 3F, 80 Device
cm
9/11/2015 MAQUET HCU 30 Base Unit Medical Recall for Class I Hospital
Device Product
Correction
9/11/2015 Rainbow Reusable Sensors for Medical Recall Class II Hospital
rainbow SET Devices with Device
SpCO, SpO2, and SpMet. (used
with pulse oximeter for the
measurement of parameters
such as arterial oxygen).
6/11/2015 Alaris System Syringe Module Medical Recall for Class I Hospital
Device Product
Correction
6/11/2015 Chlorhexidine and Cetrimide Medicine Recall Class II Consumer
irrigation solution 30mL Steritube
ampoules (chlorohexidine
gluconate 0.05%w/v and
cetrimide 0.5%w/v)
6/11/2015 Optisure Dual Coil Defibrillation Medical Hazard Alert Class I Hospital
Leads Device
6/11/2015 Philips HeartStart MRx Medical Recall for Class II Hospital
Defibrillator/Monitor Device Product
Correction
6/11/2015 Philips MX 16-slice Computer Medical Recall for Class II Hospital
tomography x-ray system Device Product
(software upgrade from Correction
v2.0.0.21479 to v2.0.0.21480)
5/11/2015 Oxoid Anti-microbial Medical Recall Class II Hospital
Susceptibility Testing Disc Device
CT0024B Gentamicin (CN 10)
5x50 discs
5/11/2015 QConnect HBVNAT Positive Medical Recall Class III Hospital
Device

Datei Levelvi
4/11/2015 Prius Elite Bed Medical Recall for Class II Hospital
Device Product
Correction
4/11/2015 Ultra-Fine Insulin Syringe for use Medical Recall Class II Hospital
with U-100 insulin Device
3/11/2015 Human Total 25-OH Vitamin D Medical Recall Class III Hospital
IVD ELISA Kit. An in vitro Device
3/11/2015 IOLMaster 500, software version Medical Recall for Class II Hospital
7.5.2, 7.7.2 and 7.7.3 Device Product
Correction
3/11/2015 Vented Paclitaxel Set (infusion Medical Recall Class II Hospital
set used during the Device
administration of medication of
anaesthetic drugs)
2/11/2015 N Latex ß2–Microglobulin Medical Recall Class II Hospital
Device
29/10/2015 ADVIA Centaur XPT. An in vitro Medical Recall for Class II Hospital
Correction
29/10/2015 SOMATOM Definition AS when Medical Recall for Class II Hospital
used with Patient table PHS1600 Device Product
and software license for Correction
"Adaptive 4D Spiral"
29/10/2015 Vital Signs LightWand Stylet Medical Recall Class II Hospital
Device
29/10/2015 Zarontin (ethosuximide) 250mg Medicine Recall Class II Retail
capsule bottle
28/10/2015 Access Free T3 Reagent Kit (For Medical Recall Class II Hospital
use with the Access Family of Device
Immunoassay Systems). An in
(IVD)
28/10/2015 ADVIA Chemistry XPT Systems Medical Recall for Class II Hospital
with software version 1.0.3. An in Device Product
(IVD)
28/10/2015 eVent Medical Inspiration LS & i Medical Recall for Class I Hospital
Series Ventilator Systems Device Product
Correction
28/10/2015 Revolution CT Scanners, Medical Recall for Class II Hospital
software version 15MW03.12 Device Product
Correction
26/10/2015 All Welch Allyn KleenSpec Medical Recall for Class II Hospital
Corded Illumination Systems Device Product
Correction
26/10/2015 Amphirion Deep Percutaneous Medical Recall Class I Hospital
Transluminal Angioplasty (PTA) Device
Balloon Dilation Catheter
26/10/2015 LifePack 1000 Automated Medical Recall for Class I Hospital
External Defibrillator (AED's), Device Product
software version 2.42 or earlier Correction

Datei Levelvi
23/10/2015 Oxoid M.I.C Evaluator for Medical Recall Class II Hospital
Penicillin 256 microgram/ml Device
22/10/2015 Access CEA Reagent Kit (For Medical Recall Class II Hospital
use with the Access Family of Device
Immunoassay Systems). An in
(IVD)
22/10/2015 Quidel Sofia Legionella FIA. An Medical Recall for Class II Hospital
(IVD) Correction
21/10/2015 BenchMark ULTRA with software Medical Recall for Class II Hospital
versions VSS 11.9 or higher, and Device Product
DISCOVERY ULTRA clinical Correction
chemistry analysers (used for
detecting and preparing tissue
morphology and components).
device (IVD).
21/10/2015 Sodium Chromate (Cr-51) Medicine Recall Class III Hospital
8MBq/mL Injections
20/10/2015 Brianlab iPlan RT Image Medical Recall for Class I Hospital
(versions below v.4.1.2) / iPlan Device Product
RT and BrainSCAN Correction
(discontinued in 2002)
20/10/2015 Epilim EC200 sodium valproate Medicine Recall Class II Retail
200mg tablet blister pack (used
for the treatment of primary
generalised epilepsy)
20/10/2015 LIFECODES LifeScreen Deluxe Medical Recall Class III Hospital
(LMX). An in vitro diagnostic Device
20/10/2015 MONACO, version 5.10.00 and Medical Recall for Class I Hospital
above Device Product
Correction
20/10/2015 MoPyc Radial Head Prosthesis Medical Recall for Class II Hospital
Stem (used in elbow Device Product
reconstruction) Correction
20/10/2015 Roche Clinical Chemistry tests Medical Recall for Class II Hospital
using NAD(H) or NADP(H) Device Product
reaction. An in vitro diagnostic Correction
20/10/2015 Triathlon MIS Modular Distal Medical Recall Class II Hospital
Capture Device
19/10/2015 AU480 Clinical Chemistry Medical Recall for Class II Hospital
Analyser - software version 1.81 Device Product
Correction
19/10/2015 Multiple Children’s Suspensions, Medicine Recall Class I Consumer
Pack size 200 ml
19/10/2015 Synchron Systems Enzymatic Medical Recall for Class III Hospital
Creatinine (CR-E) and Uric Acid Device Product
(URIC) Reagents. An in vitro Correction
15/10/2015 Vaios Total Shoulder Medical Hazard Alert Class II Hospital
Replacement System Device

Datei Levelvi
15/10/2015 VariSource iX Control Software Medical Recall for Class II Hospital
Device Product
Correction
14/10/2015 Cook Beacon Tip Angiography Medical Recall Class I Hospital
Catheters Device
14/10/2015 Enzygnost Anti-VZV/IgG Medical Recall Class II Hospital
Device
13/10/2015 Centricity PACS-IW with Medical Recall for Class I Hospital
Universal Viewer Versions 5.0 Device Product
SP2 and higher and Centricity Correction
Universal Viewer versions 6.0
and higher (used for storage and
retrieval of images used in
radiology)
13/10/2015 Disposable Myringotomy blade Medical Recall Class II Hospital
with handle (used during surgery Device
on the ear drum to relieve
pressure)
13/10/2015 LifeCycle for Prenatal Screening Medical Recall for Class II Hospital
software Device Product
Correction
13/10/2015 Plum 360 Infusion Pump, Medical Recall for Class I Hospital
Software Version 15.01.XX.009 Device Product
Correction
13/10/2015 Zimmer Natural Nail CM Long- Medical Recall for Class II Hospital
Cephalomedullary Nails Device Product
Correction
12/10/2015 EndoBarrier Gastrointestinal Medical Hazard Alert Class II Hospital
Liner System Device
12/10/2015 EnVision Flex/HRP visualisation Medical Recall Class II Hospital
reagent, part of EnVision Device
Flex/Flex+ Kits
9/10/2015 Allura Xper FD Release 8.2.16 Medical Recall for Class I Hospital
Device Product
Correction
9/10/2015 Neupogen (filgrastim) Medicine Recall Class II Hospital
480microgram 10s
9/10/2015 Pangea, USS II Polyaxial, Matrix Medical Recall for Class II Hospital
Deformity, Matrix Degenerative Device Product
and Pangea Degenerative Correction
Systems, Pedicle Awl 4.0mm
with Canevasit and Silicone
Handle (internal fixation system)
9/10/2015 Philips Brilliance 16-Slice (Air), Medical Recall for Class II Hospital
Brilliance 64 CT, Ingenuity Core, Device Product
Ingenuity Core 128, Brilliance CT Correction
Big Bore, Ingenuity Flex.
Software versions V3.6.1,
V3.6.2, V3.6.4, and V3.6.5
8/10/2015 Ethicon HARMONIC ACE+ 7 Medical Recall Class II Hospital
Laparoscopic Shears Device
8/10/2015 Sydney IVF PVP (Used during Medical Recall Class III Hospital
microinjection techniques for Device
reducing sperm motility to enable
easier capture using a pipette)

Datei Levelvi
7/10/2015 ARIA for Radiation Oncology and Medical Recall for Class I Hospital
ARIA Oncology Information Device Product
System for Radiation Oncology, Correction
Versions10.X, 11.X, 13.0 or 13.5
with Clinical Assessment licence
only
7/10/2015 MAJ-1606 instrument adaptor Medical Recall Class II Hospital
(designed for use with the Device
Olympus MAJ-1607 instrument
channel water tube)
7/10/2015 OLS-500 & OLS-700 surgical Medical Recall for Class II Hospital
lights Device Product
Correction
2/10/2015 Duracon Augments - Tibial Medical Hazard Alert Class II Hospital
Wedge Implants Device
1/10/2015 Apohealth & Terry White Medicine Recall Class II Consumer
Children's Paracetamol and
Ibuprofen children's suspensions
1/10/2015 Exeter Small and Large Tapered Medical Recall Class II Hospital
Pin Reamer (used as part of the Device
Exeter Procedure Pack)
1/10/2015 Giraffe Shuttle Products Medical Recall for Class II Hospital
(uninterruptable power supply for Device Product
Giraffe Products) Correction
1/10/2015 PCA Tapers, LFIT V40 Tapers, Medical Recall Class II Hospital
V40 Tapers (Vitallium Femoral Device
Heads)
1/10/2015 VITROS Chemistry Products Medical Recall Class I Hospital
Calibrator Kit 9 (used on Device
VITROS 250, 350, 4600, 5600
and 5,1 FS Systems). An in vitro
30/09/2015 MiniMed 640G insulin pump Medical Recall for Class II Consumer
Device Product
Correction
30/09/2015 Prism Medical P300 and C300 Medical Recall Class II Consumer
Lifts Device
30/09/2015 Shuttle Discovery Seat Medical Recall for Class II Consumer
(designed for children aged Device Product
between six months and four Correction
years who have a physical
disability)
29/09/2015 AXIOM Artis dFA, dFC, dFCM, Medical Recall for Class II Hospital
dBA, dBC, dBCM, dMP systems Device Product
with SW version VB35D Correction
29/09/2015 AXIOM Artis FA, FC, dFA, dFC, Medical Recall for Class II Hospital
dFCM, BA, BC, dBA, dBC, Device Product
dBCM, MP, dMP systems with Correction
SW version VB23N/P
29/09/2015 Brainlab Patient Data Manager Medical Recall for Class I Hospital
Device Product
Correction
29/09/2015 HeartWare Ventricular Assist Medical Recall Class I Hospital
System Battery Device

Datei Levelvi
29/09/2015 MULTIGENT Ammonia Ultra Medical Recall Class II Hospital
25/09/2015 Alkaline Phosphatase (ALPAMP, Medical Recall Class II Hospital
ALPDEA and ALPA_c) used on Device
the ADVIA 1200, 1650, 1800,
2400, and XPT Chemistry
Systems
25/09/2015 EPREX PROTECS 4000U Medicine Recall Class III Retail
6X0.4ML SYR.
25/09/2015 Intramedullary (SP 2 IM) Rod Medical Recall Class II Hospital
400mm Instrument Device
25/09/2015 PORT-A-CATH Plastic Hub Medical Recall Class II Hospital
Needles, 0.9mm (20G) x 19mm Device
(3/4 in) 90 deg
25/09/2015 PreciControl ClinChem Multi Medical Recall for Class III Hospital
1Lot No. 174787 & 174794 Device Product
Correction
22/09/2015 REFRESH NIGHT TIME and Medical Recall Class II Consumer
Ircal Eye Ointments Device
21/09/2015 Neoss Guide – Drill-Hubs I to V Medical Recall Class II Hospital
included in Neoss Device
18/09/2015 ALBAclone Anti-Leb, (LEB2) 1 x Medical Recall Class II Hospital
5mL Device
18/09/2015 Medtronic Navigated Solera Medical Recall for Class II Hospital
Driver Tips for Spinal Surgery Device Product
Correction
18/09/2015 Retractor for Sciatic Nerve; and Medical Recall Class II Hospital
Retractor for Sciatic Nerve, long Device
18/09/2015 Unitek Victory Mini Tube Lower Medical Recall Class III Hospital
Left Buccal Tube Device
17/09/2015 True Cut Oscillating Blade, Medical Recall Class III Hospital
0.9mm x 80mm x 12mm, single Device
use device (used to cut skeletal
bone and tissue)
16/09/2015 GE 3.0T MR Systems (Full body Medical Recall for Class I Hospital
MRI system): Device Product
Correction
16/09/2015 Monaco 5.10.00 Medical Recall for Class I Hospital
Device Product
Correction
16/09/2015 Suction Adapter Type A (Gauge) Medical Recall for Class II Hospital
Device Product
Correction
15/09/2015 4FR Single Lumen Pressure Medical Recall for Class I Hospital
Injectable Peripherally Inserted Device Product
Central Catheter (PICC) Correction
15/09/2015 Application Instrument for Medical Recall for Class I Hospital
Sternal ZIPFIX Device Product
Correction

Datei Levelvi
15/09/2015 Brio Charging System Model Medical Recall Class I Hospital
6721 (used with Deep Brain Device
Stimulator, Brio IPG Model 65-
6788)
15/09/2015 Bulk Loader Module for cobas p Medical Recall for Class II Hospital
471 centrifuge unit Device Product
Correction
14/09/2015 EIZO Medical Monitors Medical Recall for Class II Hospital
Device Product
Correction
14/09/2015 Novocastra Lyophilised Mouse Medical Recall Class I Hospital
Monoclonal Antibody CD10 Device
Reagents. An in vitro diagnostic
14/09/2015 seleXys TH+ and seleXys TPS Medical Hazard Alert Class II Hospital
acetabular shells Device
11/09/2015 GF-UCT180 Ultrasonic Medical Recall for Class II Hospital
Gastrovideoscope Device Product
Correction
10/09/2015 Liko Viking mobile lifts Medical Recall for Class II Hospital
Device Product
Correction
10/09/2015 SEROPHENE clomiphene citrate Medicine Recall Class III Retail
50mg tablet
8/09/2015 Base array component of the Medical Recall for Class II Hospital
MAKO RIO Robotic Arm Device Product
Correction
8/09/2015 Flexi-Slip endotracheal tube Medical Recall Class I Hospital
stylets Device
8/09/2015 Gram Crystal Violet stain Medical Recall Class III Hospital
MV1031 Device
8/09/2015 Maxi Air Blower Unit - Model Medical Recall for Class II Hospital
230V Device Product
Correction
7/09/2015 CA1:1L EVO 15 (Contrangle Medical Recall Class II Retail
used in dentistry) Device
4/09/2015 iChem Velocity Urine Chemistry Medical Recall Class II Hospital
Strips. An in vitro diagnostic Device
4/09/2015 KIMVENT Closed Suction Medical Recall for Class II Hospital
Systems (Tube, tracheal, Device Product
general-purpose, single-use) Correction
4/09/2015 Medtronic CryoConsole Medical Recall for Class II Hospital
Device Product
Correction
4/09/2015 RAPIDPoint 500 Measurement Medical Recall for Class III Hospital
Cartridges used on the Device Product
RAPIDPoint 500 System. An in Correction
(IVD)

Datei Levelvi
4/09/2015 Spectra Optia Apheresis System Medical Recall for Class I Hospital
(intended to be used to separate Device Product
blood extracted from a donor or Correction
patient into various components,
while the donor/patient is
connected to the unit)
2/09/2015 Blackmores Triple Action Bone Medicine Recall Class III Retail
Formula
2/09/2015 Coloplast urogynaecological Medical Recall for Class I Hospital
surgical mesh Device Product
Correction
2/09/2015 GYNEMESH PS and TVT Medical Recall for Class I Hospital
Devices Device Product
Correction
2/09/2015 MetaVision ICU (MV-ICU) Medical Recall for Class II Hospital
Device Product
Correction
1/09/2015 ALIQUOT Delivery System Medical Recall Class II Hospital
Complete Set (orthopaedic Device
surgical kit, used to place
injectable synthetic cortical bone
void filler in weakened or
diminished bone stock)
1/09/2015 BD Affirm VPIII Microbial Medical Recall Class II Hospital
Identification Tests (used for the Device
testing of multiple infectious
organisms). An in vitro diagnostic
31/08/2015 ACUSON SC2000 ultrasound Medical Recall for Class II Hospital
VB10B and lower Correction
31/08/2015 Medi-Trace Cadence Adult Multi- Medical Recall Class I Hospital
Function Defibrillation Device
Electrodes, Pre-connect (used in
conjunction with Automatic
External Defibrillators)
31/08/2015 syngo Lab Data Manager with Medical Recall for Class II Hospital
software version VA12B. Device Product
(Software used to supplement Correction
operational functions). An in vitro
28/08/2015 ADVIA Centaur, ADVIA Centaur Medical Recall for Class III Hospital
XP, ADVIA Centaur XPT – Device Product
HbsAgII Assay Correction
28/08/2015 Allura Xper FD Medical Recall for Class II Hospital
Device Product
Correction
28/08/2015 Apo-Paracetamol 500mg tablets, Medicine Recall Class II Retail
Bottle, 1000,
28/08/2015 Bactroban Cream (mupirocin Medicine Recall Class II Wholesale
calcium 2% w/w) 15g; and
Bactroban Nasal Ointment
(mupirocin calcium 2% w/w) 3g
28/08/2015 Cios Alpha mobile C-arm x-ray Medical Recall for Class II Hospital
Correction

Datei Levelvi
28/08/2015 Dimetapp Daytime/Night time Medicine Recall Class II Retail
Liquid Caps
28/08/2015 Philips HeartStart MRx Medical Recall for Class III Hospital
Monitor/Defibrillator with Q-CPR Device Product
Correction
27/08/2015 ABL90Flex battery module used Medical Recall for Class II Hospital
with Radiometer ABL90FLEX Device Product
blood gas analyser (Optional Correction
battery). An in vitro diagnostic
27/08/2015 CONTOUR NEXT control Medical Recall for Class I Hospital
solutions. In vitro diagnostic Device Product
27/08/2015 Disposable Reflective Marker Medical Recall for Class II Hospital
Spheres Device Product
Correction
27/08/2015 Mitoxantrone Hydrochloride Medicine Recall Class III Hospital
Injection Concentrate 20mg/10ml
27/08/2015 Shen Neng Ching Fei Yi Hou Medicine Recall Class II Retail
Pien
27/08/2015 WATCHMAN Left Atrial Medical Recall for Class I Hospital
Appendage Closure Device with Device Product
Delivery System Correction
26/08/2015 chromID S.aureus agar Medical Recall for Class II Hospital
(SAID/MRSA). An in vitro Device Product
25/08/2015 Actifuse ABX and Actifuse MIS Medical Recall Class I Hospital
System Device
25/08/2015 Edwards Pressure Monitoring Kit Medical Recall Class II Hospital
& Set, Model Number: Device
PXMK2043
21/08/2015 Alaris System Syringe Module Medical Recall for Class I Hospital
Device Product
Correction
21/08/2015 DIRECTVIEW Software versions Medical Recall for Class II Hospital
5.6 & greater and 5.7 with DR Device Product
LLI Auto Stitch option on DRX Correction
Evolution with Premium and Full
Featured Wall Stands
21/08/2015 LX3 Microscope Floor Stand Medical Recall for Class I Hospital
used with the LuxOR Ophthalmic Device Product
Microscope and LuxOR Correction
Ophthalmic Microscope with Q-
VUE 3D Assistant Visualisation
(used during ophthalmic surgical
procedure for cataract, retina
and cornea)
20/08/2015 Brilliance 64, Ingenuity CT, Medical Recall for Class II Hospital
Ingenuity Core, and Ingenuity Device Product
Core128 with the following Correction
versions:

Datei Levelvi
20/08/2015 RF enabled St. Jude Medical Medical Hazard Alert Class II Hospital
Ellipse, Fortify Assura, Unify Device
Assura, and Quadra Assura
Implantable Cardioverter
Defibrillators (ICDs) and Assurity
and Allure Pacemakers when
used with Merlin@home RF
Remote Monitoring Transmitter
Model EX1150
19/08/2015 Alcon 23 Gauge and 25 Gauge Medical Recall for Class II Hospital
Valved entry systems Device Product
Correction
19/08/2015 Fentanyl Intranasal Spray Medicine Recall Class II Hospital
600ug/2mL
19/08/2015 PROFEMUR NECK VAR/VAL Medical Hazard Alert Class II Hospital
8DG, Long Cobalt Chrome, Part Device
number PHAC1254
17/08/2015 Etoposide (as phosphate) 200mg Medicine Recall Class I Hospital
in 10mL in 20mL and 165mg in
8.3mL in 10mL syringe for
Intravenous injection
17/08/2015 FreeStyle Optium Neo Blood Medical Recall Class II Retail
Glucose and Ketone Monitoring Device
System. An in vitro diagnostic
17/08/2015 Xia 3 Titanium Torque Wrench Medical Recall Class II Hospital
Device
13/08/2015 DigitalDiagnost, Release Medical Recall for Class II Hospital
4.1/4.1.1 Device Product
Correction
13/08/2015 Extension Set Medical Recall Class II Hospital
Device
13/08/2015 Philips Trauma Diagnost X-ray Medical Recall for Class II Hospital
Correction
13/08/2015 VEPTR Vertical Expandable Medical Recall Class II Hospital
Prosthetic Titanium Rib Device
13/08/2015 Volcano IVUS Ultrasound Medical Recall for Class II Hospital
Imaging System Device Product
Correction
VA16A to VA30A and the Stress Correction
Echo Option
12/08/2015 ADVIA Chemistry System – Urea Medical Recall for Class III Hospital
Nitrogen and Urea Nitrogen Device Product
Concentrated Assays. An in vitro Correction
12/08/2015 Arrow International 4Fg Medical Recall Class II Hospital
Seldinger Conversion Set with Device
Long Sheath
12/08/2015 EXACTRAC Version 6.0.0 Medical Recall for Class I Hospital
through to 6.0.5 Device Product
Correction

Datei Levelvi
12/08/2015 Sinus-SuperFlex-635 Self- Medical Recall Class I Hospital
expanding Nitinol Stent System Device
11/08/2015 BD Vacutainer Eclipse Signal Medical Recall for Class II Hospital
Blood Collection Needle with Device Product
Integrated Holder 21G & 22G. Correction
11/08/2015 VIRAZOLE (Ribavirin) Solution Medicine Recall Class I Hospital
for Injection 0.1g/mL, 12 x 5 mL
vials
7/08/2015 Access Thyroglobulin Reagent Medical Recall Class II Hospital
device (IVD)
7/08/2015 AIR LIQUIDE Medical Carbon Medicine Recall Class II Hospital
Dioxide labelled as Medical Air
7/08/2015 DePuy Synthes Socket, Medical Recall Class II Hospital
Hexagonal Ø 4.0mm/11.0mm. Device
6/08/2015 Siesta i TS machine Medical Recall for Class II Hospital
Device Product
Correction
5/08/2015 Bortezomib 2.4mg Syringe Medicine Recall Class II Hospital
5/08/2015 Leica ASP200S & Leica Medical Recall for Class II Hospital
ASP300S. In vitro diagnostic Device Product
5/08/2015 Medcomp Hemo-Cath LT and Medical Recall for Class I Hospital
Hemo-Cath ST Hemodialysis Device Product
catheters Correction
4/08/2015 IntelePACS software versions Medical Recall for Class II Hospital
from 4.5.1 to 4.11.1. Device Product
Correction
4/08/2015 Waratah Private General Packs Medical Recall for Class II Hospital
and Waratah Private Device Product
Knee/Shoulder Arthro Pack Correction
3/08/2015 GE Healthcare LightSpeed CT Medical Recall for Class II Hospital
scanners & Discovery PET CT Device Product
scanners with replacement Correction
MDAS 16 5V Power Supply (part
number 2334455)
3/08/2015 UniCel DxC ISE Reference Medical Recall for Class II Hospital
reagent tubing Device Product
Correction
31/07/2015 Contact Detach Infusion Sets ( Medical Recall for Class II Consumer
used in conjunction with a pump Device Product
to deliver a continuous dose of Correction
insulin)
31/07/2015 RAPIDPoint 500 Blood Gas Medical Recall for Class I Hospital
Analyzer Device Product
Correction
29/07/2015 Pharmacy Care Children’s Medicine Recall Class I Consumer
Paracetamol Suspension for 6
To 12 Years and Pharmacy Care
Children’s Paracetamol Elixir for
1 to 5 Years

Datei Levelvi
29/07/2015 Pharmacy Choice Children’s Medicine Recall Class I Consumer
Paracetamol 6 To 12 Years
Concentrated 200ml and
Pharmacy Choice Ibuprofen
Children's Suspension
28/07/2015 Artis systems used in Medical Recall for Class II Hospital
conjunction with Artis table Device Product
Correction
28/07/2015 Dimension Creatinine and Medical Recall for Class II Hospital
Dimension Vista Creatinine Device Product
Assays. An in vitro diagnostic Correction
28/07/2015 Product-CD30 (Ber-H2) Medical Recall Class III Hospital
Device
28/07/2015 Sureshot Humeral 3.2mm AO Medical Recall Class II Hospital
Drill Device
24/07/2015 Back Table Cover supplied in a Medical Recall for Class II Hospital
limited range of Operating Room Device Product
Packs Correction
23/07/2015 Da Vinci Xi Surgical System - Medical Recall for Class II Hospital
Breakage of input disks of Device Product
Endowrist instruments Correction
23/07/2015 N Latex ß2–Microglobulin. An in Medical Recall Class III Hospital
(IVD)
22/07/2015 ReTurnBelt wipeable Medical Recall Class II Hospital
Device
21/07/2015 iChemVELOCITY Automated Medical Recall for Class II Hospital
Urine Chemistry System using Device Product
iChemVELOCITY Urine Correction
Chemistry Strips
21/07/2015 Medtronic Activa PC, Activa SC, Medical Hazard Alert Class I Hospital
Activa RC, Kinetra and Soletra Device
Implantable Deep Brain
Stimulators (DBS)
21/07/2015 MR ACGD Cabinet FRU X Medical Recall for Class I Hospital
Gradient Cable used with GE Device Product
MRI System Correction
21/07/2015 NeoMode software used on Medical Recall for Class I Hospital
Puritan Bennett 980 Series Device Product
(PB980) Universal Ventilator Correction
System
20/07/2015 Cook Beacon Tip angiography Medical Recall Class I Hospital
catheters Device
20/07/2015 Medtronic MiniMed 640G Insulin Medical Recall for Class I Consumer
Pumps Device Product
Correction
17/07/2015 Reamer/Irrigator/Aspirator (RIA) Medical Recall for Class II Hospital
Device Product
Correction
17/07/2015 Siemens e.cam Systems Medical Recall for Class I Hospital
Device Product
Correction

Datei Levelvi
16/07/2015 Sapphire Infusion Pump Medical Recall for Class II Hospital
Device Product
Correction
15/07/2015 Bard Rival PTA Catheters Medical Recall for Class II Hospital
Device Product
Correction
15/07/2015 Radiometer 905-873 Fixation Kit Medical Recall Class II Hospital
N20 Device
15/07/2015 Vygon SA – Y connector code Medical Recall Class I Hospital
884.08 Device
15/07/2015 X3 TRIATHLON INSERT CR#2 Medical Recall Class II Hospital
9MM Device
14/07/2015 ARCHITECT B12 Reagent kit Medical Recall for Class II Hospital
Device Product
Correction
14/07/2015 Artis Q and Q.zen Floorstand Medical Recall for Class II Hospital
and ArtisQ and Q.zen Biplane Device Product
Floorstand systems with SW Correction
version VD10E
14/07/2015 DELFIA Xpress PlGF Kit Medical Recall for Class II Hospital
Device Product
Correction
14/07/2015 Navigational System II - Cart Medical Recall for Class II Hospital
Device Product
Correction
14/07/2015 Tumor Localization (TumorLOC) Medical Recall for Class I Hospital
software application used on Device Product
Philips PET/CT combination Correction
diagnostic imaging systems
9/07/2015 MicroGas 7650 Operator Manual Medical Recall for Class II Hospital
used with Radiometer MicroGas Device Product
7650 Transcutaneous Monitor Correction
8/07/2015 Artis systems with SW version Medical Recall for Class II Hospital
VC14J Device Product
Correction
8/07/2015 iPlan RT Dose, versions 4.0 and Medical Recall for Class I Hospital
4.1 (including all subversions) Device Product
Correction
8/07/2015 Milestone Wand STA Hand Medical Recall Class III Retail
Piece model STA-5050-305 Device
8/07/2015 Optional PS500 External Power Medical Recall for Class I Hospital
Supply Unit used in connection Device Product
with Dräger V Series Ventilators: Correction
Infinity V500; Babylog VN500;
Evita V300
8/07/2015 Terry White Chemists Ibuprofen Medicine Recall Class I Consumer
Children's Suspension Ibuprofen
20 mg/mL oral liquid bottle 200
mL
7/07/2015 ACUSON S Family Ultrasound Medical Recall for Class II Hospital
Systems utilising the 18L6 HD Device Product
and/or 6C1 HD biopsy guidelines Correction

Datei Levelvi
7/07/2015 Aequalis IM Nail Targeting Jig Medical Recall Class II Hospital
Device
7/07/2015 MOSAIQ versions 2.41 and Medical Recall for Class I Hospital
higher Device Product
Correction
7/07/2015 VITROS 5,1 FS System Medical Recall for Class II Hospital
Device Product
Correction
3/07/2015 ACUSON S1000, ACUSON Medical Recall for Class II Hospital
S2000, or ACUSON S3000 Device Product
Ultrasound Systems with Correction
software version VC30A, VC30B,
VC30C, or VC31A
3/07/2015 Acuson S2000 and Acuson Medical Recall for Class I Hospital
S3000 Ultrasound Systems with Device Product
the Virtual Touch IQ option Correction
3/07/2015 Medline procedure packs Medical Recall Class II Hospital
containing Unomedical Suction Device
Tubing (Sterile and Non-sterile)
3/07/2015 Neria Infusion Administration Set Medical Recall Class II Consumer
Device
2/07/2015 ADVIA Chemistry Systems - Medical Recall for Class II Hospital
Acetaminophen N-acetylcysteine Device Product
(NAC). An in vitro diagnostic Correction
2/07/2015 Ceiling Supply Unit klinoPORT Medical Recall for Class II Hospital
Device Product
Correction
2/07/2015 Chemmart & Pharmacy Choice Medicine Recall Class I Consumer
Ibuprofen Children's Suspension
20mg/mL and Chemmart
Children's Paracetamol 6 to12
years Concentrated 200mL
48mg/mL oral liquid bottles, Pack
Size 200 mL
2/07/2015 Invivo Expression MRI Patient Medical Recall for Class I Hospital
Monitoring System - Product Device Product
865214 Correction
2/07/2015 Multigate Custom Procedure Medical Recall Class II Hospital
Packs containing Convatec’s Device
Unomedical brand Suction Tube
2/07/2015 Multiple Allura systems Medical Recall for Class I Hospital
Device Product
Correction
2/07/2015 Philips HeartStart XL+ Medical Recall for Class I Hospital
Correction
2/07/2015 PRIMENE 10% amino acids Medicine Recall for Class I Hospital
solution for injection bottle Product
Correction
1/07/2015 Procise EZ View with Integrated Medical Recall Class II Hospital
Cable Device

Datei Levelvi
30/06/2015 Neptune 2 Rovers Medical Recall for Class III Hospital
Device Product
Correction
30/06/2015 SENSE Body Coil 1.5T used with Medical Recall for Class II Hospital
ACS NT, Intera 1.5T and Device Product
Achieva 1.5T MR Systems Correction
29/06/2015 Enbrel etanercept (reh) 25 mg Medicine Recall Class III Hospital
powder for injection vial plus
diluent syringe
29/06/2015 Parechovirus r-gene. An in vitro Medical Recall for Class II Hospital
Correction
29/06/2015 Pull Reduction Device for Medical Recall Class II Hospital
Percustaneous Drill Guide Device
4.3mm (Supplied as part of the
VA Distal Femur set)
29/06/2015 SERFAS 90° Energy Probe (90R Medical Recall Class II Hospital
Probe) Device
26/06/2015 Abutment Retrieval Instrument Medical Recall Class III Retail
Zirconia CC RP/WP Device
26/06/2015 All Precision 500D Radiographic Medical Recall for Class II Hospital
and Fluoroscopic (R&F) Systems Device Product
and Advantx Legacy/Legacy-D Correction
Radiographic and Fluoroscopic
(R&F) Systems
26/06/2015 i-STAT PT/INR Cartridges Medical Recall for Class II Hospital
Device Product
Correction
26/06/2015 Masimo uSpO2 and HPLP Medical Recall Class I Hospital
Oximetry Cables Device
26/06/2015 Single and dual LCD monitor Medical Recall for Class II Hospital
suspensions used on Precision Device Product
RXi fluoroscopic imaging Correction
systems
26/06/2015 Stryker Trauma rHead Recon, Medical Recall Class II Hospital
Bipolar & Radial Stem Implants Device
(Components of elbow joint
implants)
25/06/2015 Reusable Stripper and Cleaver Medical Recall Class II Hospital
Accessories used with Sureflex Device
and Aura Laser Fibers
24/06/2015 cCrea A+B Membranes used Medical Recall for Class II Hospital
with ABL800 series blood gas Device Product
analyser range Correction
24/06/2015 GM-KO-67000-120 Paediatric Medical Recall Class II Hospital
120” Circuit Device
23/06/2015 3M ESPE Lava Ultimate Medical Recall for Class II Retail
CAD/CAM Restorative Device Product
Correction
23/06/2015 Brainlab Cranial Navigation Medical Recall for Class I Hospital
System (all versions before Device Product
Cranial 3.0) Correction

Datei Levelvi
22/06/2015 Artis zee and Artis zeego Medical Recall for Class II Hospital
systems used in conjunction with Device Product
a triple focus x-ray tube Correction
assembly
22/06/2015 Barco Surgical Displays Medical Recall for Class II Hospital
Device Product
Correction
19/06/2015 ARGON Bone Marrow I-type Medical Recall Class II Hospital
aspirate/biopsy needles & Device
ARGON Trap-Lok Bone Marrow
biopsy needles
19/06/2015 Cook LapSac Surgical Tissue Medical Recall for Class II Hospital
Pouch Device Product
Correction
19/06/2015 Drager Fabius MRI Anaesthesia Medical Recall for Class I Hospital
Machine Device Product
Correction
19/06/2015 Lunderquist Extra-Stiff Wire Medical Recall Class II Hospital
Guide Device
19/06/2015 Medtronic MiniMed Sure-T Medical Recall for Class II Consumer
infusion sets Device Product
Correction
19/06/2015 MobileDiagnost wDR 1 and 2 Medical Recall for Class II Hospital
Device Product
Correction
19/06/2015 TOPCON – 3D Optical Medical Recall for Class II Hospital
Coherence Tomography 3D Device Product
OCT-1 MAESTRO machines Correction
17/06/2015 Edwards Lifesciences Heart Medical Recall for Class I Hospital
Reference Sensor Device Product
Correction
17/06/2015 Immulite (all systems) - Sample Medical Recall Class II Hospital
Cup Holders and Microsample Device
Inserts. In vitro diagnostic
medical devices (IVD)
17/06/2015 Suction Tube Medical Recall Class II Hospital
Device
16/06/2015 CEFOTAXIME CT 256 WW Medical Recall Class II Hospital
F100. An in vitro diagnostic Device
16/06/2015 Paclitaxel Suspension Medicine Recall Class II Retail
(Abraxane) 207.5mg in 0.9%
Sodium Chloride
16/06/2015 Sorin 1T & 3T Heater Cooler Medical Recall for Class I Hospital
Device Product
Correction
12/06/2015 Access 2 Immunoassay Systems Medical Recall for Class II Hospital
Device Product
Correction
12/06/2015 BIRMINGHAM HIP Resurfacing Medical Hazard Alert Class II Hospital
(BHR) System Device
12/06/2015 NDI Disposable Reflective Medical Recall Class II Hospital
Marker Spheres Device

Datei Levelvi
12/06/2015 Philips Respironics Devices used Medical Recall for Class I Hospital
for Auto Servo-Ventilation Device Product
Therapy: Correction
12/06/2015 SOMATOM Emotion 6 / 16 Slice Medical Recall for Class I Hospital
Configuration systems Device Product
manufactured before February Correction
2008
12/06/2015 Tina-quant Soluble Transferrin Medical Recall Class II Hospital
Receptor (STFR): Elevated Device
imprecision with QC Level 1
12/06/2015 UniCel DxI Immunoassay Medical Recall for Class II Hospital
Correction
10/06/2015 Ultrasound Q-Station version 3.0 Medical Recall for Class II Hospital
or higher Device Product
Correction
9/06/2015 Stryker Neurovascular Excelsior Medical Recall Class II Hospital
SL-10/Excelsior 1018 Device
Microcatheters
5/06/2015 ACCURUS Vitrectomy probes Medical Recall Class I Hospital
Device
5/06/2015 Artis zee Floorstand, Artis zee Medical Recall for Class II Hospital
Biplane Floorstand and Artis zee Device Product
Multi Purpose systems with SW Correction
version VC21B
5/06/2015 Disposable StrykeFlow Tip Medical Recall Class II Hospital
Device
5/06/2015 SofPort Advanced Optics Medical Hazard Alert Class II Hospital
Aspheric IOL, Model LI61AO Device
5/06/2015 Tibial Alignment Guide – iAssist Medical Recall for Class II Hospital
Knee System Device Product
Correction
5/06/2015 VITROS Performance Verifier I Medical Recall for Class II Hospital
for unconjugated bilirubin (Bu) Device Product
Correction
4/06/2015 Per-Q-Cath PICCs Medical Recall for Class II Hospital
Device Product
Correction
3/06/2015 TJF-Q180V Duodenoscope Medical Recall for Class I Hospital
Device Product
Correction
3/06/2015 Verathon GlideScope GVL and Medical Recall for Class II Hospital
AVL Reusable Video Device Product
Laryngoscope Blades Correction
2/06/2015 Digital Radiography X-Ray Medical Recall for Class II Hospital
System DX-D 100 Type 5410 or Device Product
DX-D 100 Wireless Type 5411 Correction
2/06/2015 MAGNUS Hybrid OR table Medical Recall for Class II Hospital
column 1180.01B2 Device Product
Correction
2/06/2015 Medtronic Navigated Cannulated Medical Recall for Class II Hospital
Taps Device Product
Correction

Datei Levelvi
2/06/2015 Roche clinical chemistry tests - Medical Recall for Class II Hospital
ALT, AST, CK, CK-MB, GLDH Device Product
and NH3 using the NAD(H) or Correction
NADP(H) reaction
29/05/2015 DigitalDiagnost Release 4.0.x Medical Recall for Class II Hospital
Device Product
Correction
29/05/2015 Eon Wall Charger Model 3701 Medical Recall Class I Hospital
and Eon Portable Charger Model Device
3711 (Implantable pulse
generator chargers)
28/05/2015 CADD- Solis Ambulatory Infusion Medical Recall for Class II Hospital
Correction
28/05/2015 Shen Neng Qianbai Biyan Pian - Medicine Recall Class II Retail
(A Rhinitis Treatment in
Traditional Chinese Medicine)
28/05/2015 syngo Workflow SLR with Medical Recall for Class II Hospital
versions VA31, VA32, VB10, or Device Product
VB20A (TBC) Correction
28/05/2015 Ultraview SL Command Module Medical Recall for Class II Hospital
Device Product
Correction
27/05/2015 18F-Fludeoxyglucose Injection Medicine Recall Class II Hospital
v4.0, v4.0 Rev 2 and v4.0 Rev 3. Device Product
device (IVD)
27/05/2015 ONCENTRA Brachy version 3.x Medical Recall for Class I Hospital
and 4.x Device Product
Correction
27/05/2015 Surface Applicator Set with Medical Recall for Class II Hospital
Leipzig-style Cone Device Product
Correction
25/05/2015 ADVIA Centaur TnI-Ultra Medical Recall for Class II Hospital
Device Product
Correction
25/05/2015 Pulsar-35 and Pulsar-18 and Medical Recall Class I Hospital
peripheral self-expanding Nitinol Device
stent systems (with stent length
of 200 mm only)
25/05/2015 Teflon Tube T2 Humerus, Sterile Medical Hazard Alert Class II Hospital
Device
22/05/2015 EPREX (Epoetin alfa) syringes Medicine Recall Class III Retail
22/05/2015 EVOTECH Endoscope Cleaner Medical Recall for Class III Hospital
and Reprocessor (ECR) Device Product
Correction
21/05/2015 CareFusion - AVEA Ventilator Medical Recall for Class I Hospital
Device Product
Correction

Datei Levelvi
20/05/2015 Berichrom Protein C on Sysmex Medical Recall for Class II Hospital
CA-1500, CA-7000, CS-2000i Device Product
and CS-5100 instruments. An in Correction
(IVD).
20/05/2015 Dimension Vista 500 and 1500 Medical Recall for Class II Hospital
Intelligent Lab System. An in Device Product
(IVD)
20/05/2015 Philips Model AFFINITI 70 Medical Recall for Class II Hospital
Ultrasound System Versions Device Product
1.0.2 or lower with Pediatric Correction
Cardiology option
Products NT-proBNP Assay. An Device Product
in-vitro diagnostic medical device Correction
(IVD)
18/05/2015 Animas 2020 and Animas IR Medical Recall Class I Consumer
1200 Insulin Pumps Device
18/05/2015 Apex 10mm reamer Medical Recall Class I Hospital
Device
18/05/2015 APO-Dipyridamole Aspirin Medicine Recall Class III Wholesale
200mg/25mg capsules in bottles
of 60s
18/05/2015 CHISEL BLADES Medical Recall Class III Hospital
Device
18/05/2015 DuraDiagnost 3.0/4.0 X-ray Medical Recall for Class II Hospital
Correction
18/05/2015 Expression MRI Patient Medical Recall for Class II Hospital
Monitoring System Device Product
Correction
18/05/2015 PenAdapt Medical Recall Class II Hospital
Device
18/05/2015 TCAutomation / enGen Medical Recall for Class II Hospital
Laboratory Automation Systems. Device Product
device (IVD)
18/05/2015 WIZARD2 Gamma Counters Medical Recall for Class II Hospital
Device Product
Correction
15/05/2015 IntelePACS Medical Recall for Class II Hospital
Device Product
Correction
15/05/2015 Manual Collimator Exchange Medical Recall for Class II Hospital
system in use with an ADAC Device Product
VERTEX Plus, CARDIO, SOLUS Correction
or VERTEX V60 imaging system
Ultrasound System without Device Product
Pediatric Cardiology option Correction
15/05/2015 Philips Model EPIQ 7 Ultrasound Medical Recall for Class II Hospital
System with Pediatric Cardiology Device Product
option Correction

Datei Levelvi
15/05/2015 RAPIDLab 1260/1265 Systems. Medical Recall for Class II Hospital
14/05/2015 High Strength Niuhuang Jiedu Medicine Recall Class II Consumer
Tablets 60’s
Ultrasound System Device Product
Correction
System without Paediatric Device Product
Cardiology option Correction
14/05/2015 ReMed devices used for Medical Recall for Class I Consumer
Adaptive Servo-Ventilation (ASV) Device Product
Therapy Correction
13/05/2015 Cios Alpha mobile C-arm x-ray Medical Recall for Class II Hospital
Correction
13/05/2015 Immulite 2000 and Immulite Medical Recall Class II Hospital
2000 XPi – Italian Cypress Device
Allergen
13/05/2015 Microtek Medical System Drapes Medical Recall Class II Hospital
used with da Vinci, da Vinci Si, Device
da Vinci Si/S Systems
13/05/2015 Prius Hospital Bed Medical Recall for Class III Hospital
Device Product
Correction
13/05/2015 Shiley Neonatal, Paediatric and Medical Recall Class I Hospital
Long Paediatric Tracheostomy Device
Tube, Cuffless and with
TaperGuard Cuff
13/05/2015 Trinder tests on Roche Medical Recall for Class II Hospital
Analysers – Hitachi 902, COBAS Device Product
c111, COBAS Correction
c311/501/502/701/702 & COBAS
INTEGRA 400 plus/800. An in
(IVD)
13/05/2015 ULTRA FAST-FIX Knot Medical Recall Class II Hospital
Pusher/Suture Cutter, Straight Device
12/05/2015 Astral Ventilators Medical Recall for Class I Consumer
Device Product
Correction
12/05/2015 Brainlab Navigation Software Medical Recall for Class I Hospital
Spine & Trauma 3D versions 2.0 Device Product
/2.1 and Navigation Software Correction
Cranial / ENT version 2.1
12/05/2015 Diego Elite Tubesets Medical Recall Class II Hospital
Device
System Versions 1.3.2 or lower Device Product
without Paediatric Cardiology Correction
option

Datei Levelvi
System with Versions 1.3.2 or Device Product
lower with Paediatric Cardiology Correction
option
11/05/2015 MRS Traverse Switch Medical Recall for Class II Hospital
Device Product
Correction
8/05/2015 Medline Procedure Packs Medical Recall for Class II Hospital
containing Covidien Devon Light Device Product
Gloves Correction
7/05/2015 Corpatch Easy Paediatric Medical Recall Class I Hospital
(defibrillator electrodes) Device
7/05/2015 HeartWare HVAD System Medical Recall for Class I Hospital
Device Product
Correction
7/05/2015 Invacare Platinum Oxygen Medical Recall for Class I Consumer
Concentrator Device Product
Correction
7/05/2015 Sekisui Diagnostics Medical Recall for Class II Hospital
Acetaminophen Reagent. An in Device Product
(IVD)
6/05/2015 Sapheon (Covidien) VenaSeal Medical Recall Class II Hospital
Closure System Device
5/05/2015 MV1031 Gram Crystal Violet 4L. Medical Recall Class III Hospital
device (IVD)
5/05/2015 Remel PathoDx Strep Grouping Medical Recall Class II Hospital
Kit 60 Test containing Remel Device
PathoDx Strep B Group Latex.
device (IVD)
5/05/2015 TFN-ADVANCED Proximal Medical Recall for Class II Hospital
Femoral Nailing System (TFNA) Device Product
Correction
4/05/2015 LP rotate, sizes 25-27 cat.1-6. Medical Recall Class II Consumer
Device
1/05/2015 VITEK2 AST-YS06 & VITEK2 Medical Recall for Class I Hospital
AST-YS07 Test Kits Device Product
Correction
1/05/2015 V-Sign Sensor Medical Recall Class II Hospital
Device
30/04/2015 OPTI Blood Gas analysers - An Medical Recall for Class II Hospital
(IVD) Correction
30/04/2015 Transwarmer Infant Transport Medical Recall Class II Hospital
Mattress Device
29/04/2015 Tavo ophthalmic Table Medical Recall for Class I Hospital
Device Product
Correction

Datei Levelvi
28/04/2015 Factor IX coagulation studies on Medical Recall for Class II Hospital
the BCS / BCS XP Automated Device Product
Blood Coagulation Analyser Correction
(Actin, Actin FSL and Pathromtin
SL)
28/04/2015 IMMULITE 2000 IMMULITE Medical Recall for Class III Hospital
2000 XPi Immunoassay System. Device Product
device (IVD)
27/04/2015 D-Fend/D-Fend+ water traps Medical Recall for Class I Hospital
used with Compact Airway Device Product
Modules E/M-C(Ai)O(V)(X) and Correction
Cardiocap/5 monitors
27/04/2015 Talon Grasping Device Medical Recall Class II Hospital
Device
24/04/2015 DBL Methotrexate 2.5mg tablets Medicine Recall Class II Consumer
in bottles of 30
24/04/2015 Devon Light Glove Medical Recall Class II Retail
Device
24/04/2015 Invacare TDX series and Storm Medical Recall for Class I Consumer
Series power wheelchairs with Device Product
20”-24” width configurations with Correction
Formula CG Recline seating
system (i.e. Tilt/Recline,
Tilt/Recline/Elevate, or Recline
only) and a conventional style
back
24/04/2015 Philips Dameca Siesta i TS with Medical Recall for Class I Hospital
an EGM software version lower Device Product
than 4.0.8 / 7.0.8 Correction
24/04/2015 Thermablate Endometrial Medical Recall for Class II Hospital
Ablation System (EAS) Device Product
Correction
23/04/2015 Connecting Screw for Insertion Medical Recall Class II Hospital
of Dynamic Hip Screw (DHS) Device
Blade
23/04/2015 Dimension Vista Systems LOCI Medical Recall Class II Hospital
Thyroid Stimulating Hormone. An Device
(IVD)
23/04/2015 Oscillating Saw Attachment for Medical Recall for Class I Hospital
Colibri/Colibri II Small Electric Device Product
Drive Correction
23/04/2015 Siemens Ysio Max, Luminos Medical Recall for Class II Hospital
dRF Max, Luminos Agile Max Device Product
and Uroskop Omnia Max with Correction
software version VE10E
22/04/2015 Codan Extension Set With Medical Recall for Class III Hospital
SAFTI-JECT SV Swabable Valve Device Product
Needleless Connector And a Correction
Back Check Valve - 28 cm.
(Tubing to extend the length of
an IV administration set)

Datei Levelvi
22/04/2015 SonoSitePowerPark Dock and Medical Recall for Class II Hospital
Stand Module(s) used with Device Product
SonoSite Ultrasound Systems Correction
21/04/2015 Accu-Chek Spirit Combo insulin Medical Recall for Class I Consumer
pump and Accu-Chek Spirit Device Product
insulin pump. An in vitro Correction
(BHMH) Device
20/04/2015 Ki67-MM1 Bond Ready To Use, Medical Recall Class I Hospital
device (IVD)
20/04/2015 Philips Ultrasound QLAB Medical Recall for Class II Hospital
versions 10.0 with a2DQ and/or Device Product
aCMQ plug-ins installed with Correction
Philips Xcelera software
17/04/2015 Amylase Assay used with ADVIA Medical Recall for Class II Hospital
Chemistry Systems Device Product
Correction
17/04/2015 Counterfeit Durex branded Medical Recall Class I Consumer
condoms purchased from Device
Groupon website
17/04/2015 Different Brands of Pantoprazole Medicine Recall Class III Retail
Tablets in Blisters of 30’s.
17/04/2015 Intuitive Surgical Inc. da Vinci Xi Medical Recall for Class II Hospital
Surgical System Patient Cart Device Product
Arms Correction
16/04/2015 LEMTRADA (alemtuzumab) Medicine Recall for Class II Hospital
10mg/mL injection concentrated Product
vial Correction
16/04/2015 Magellan Robotic System Medical Recall for Class I Hospital
(Catheter controller steering unit Device Product
) Correction
15/04/2015 Harris Oxygen Flowmeter Medical Recall for Class II Hospital
Device Product
Correction
14/04/2015 Dako Beta-2-Microglobulin PET Medical Recall Class II Hospital
Kits. An in vitro diagnostic Device
14/04/2015 Karl Storz Tissue Morcellation Medical Recall for Class II Hospital
Correction
14/04/2015 VITROS Chemistry Systems. An Medical Recall for Class II Hospital
(IVD). Correction
13/04/2015 Bard Max-Core Disposable Core Medical Recall Class I Hospital
Biopsy Instrument Device
13/04/2015 enGen Laboratory Automation Medical Recall for Class II Hospital
Systems, An in vitro diagnostic Device Product
13/04/2015 ID-LISS/Coombs Cards. An in Medical Recall Class II Hospital
(IVD)

Datei Levelvi
13/04/2015 STERIS Caviwave Pro Medical Recall for Class II Hospital
Ultrasonic Cleaning System Device Product
Correction
10/04/2015 Baxter Irrigation solutions Medical Recall Class II Hospital
Device
10/04/2015 Dianeal peritoneal dialysis Medicine Recall Class I Consumer
solutions
10/04/2015 Easyvision Umere Daily Contact Medical Recall Class II Consumer
Lenses (-6.50) Device
10/04/2015 KARMA Corneal Inlay Medical Recall for Class II Hospital
Device Product
Correction
8/04/2015 Curam Duo Forte 875mg/125mg Medicine Recall Class III Retail
Tablets 10 strip
2/04/2015 Aegis Standing Sling - Lift, Medical Recall for Class II Retail
patient transfer, Device Product
sling/harness/strap Correction
2/04/2015 Nobel Replace Conical Medical Recall Class III Hospital
Connection PMC RP 5.0x13mm Device
1/04/2015 CIDEX OPA Solution Test Strips Medical Recall for Class III Hospital
Device Product
Correction
1/04/2015 Uninterruptible Power Supply Medical Recall for Class II Hospital
(UPS) supplied with Philips Device Product
Computed Tomography / Correction
Advanced Molecular Imaging
Systems
31/03/2015 Alaris System PC Unit model Medical Recall for Class II Hospital
8015 Device Product
Correction
31/03/2015 Cross-Link Clamp for Rods, 6.0 Medical Recall Class II Hospital
mm Device
31/03/2015 Edwards Fem-Flex II Femoral Medical Recall Class II Hospital
Arterial Cannula, sizes 8, 10 & Device
12 French
30/03/2015 CBCII AMBULATING BULB Medical Recall Class II Hospital
(PK10), 1/8 TROCAR W/DRAIN Device
(PK10), 1/4 TROCAR W/DRAIN
(PK10)
30/03/2015 KA351 - My Mobility Walking Medical Recall for Class II Retail
Frame with Front Wheels, Large, Device Product
Aluminium, APO Grey, and Correction
27/03/2015 Angular Stable Locking System Medical Recall Class II Hospital
(ASLS), 5.0 mm, Resorbable Device
(Used with Synthes cannulated
titanium intramedullary nails)
27/03/2015 Bard ConQuest PTA Balloon Medical Recall Class I Hospital
Dilatation Catheter Device
27/03/2015 Captia Malaria EIA Medical Recall for Class II Hospital
Device Product
Correction

Datei Levelvi
27/03/2015 da Vinci Si EndoWrist One Medical Recall for Class II Hospital
Vessel Sealer and da Vinci Xi Device Product
EndoWrist Vessel Sealer Correction
27/03/2015 Radiometer immunoassay Medical Recall for Class I Hospital
AQT90FLEX Analyser Device Product
Correction
26/03/2015 ADVIA Chemistry Systems Medical Recall for Class II Hospital
Lipase Assay Device Product
Correction
26/03/2015 Trellis 6 and Trellis 8 Peripheral Medical Recall Class II Hospital
Infusion System Device
25/03/2015 GE MRI Systems Medical Recall for Class II Hospital
Device Product
Correction
24/03/2015 LCS COMPLETE RPS Knee Medical Hazard Alert Class II Hospital
System Device
23/03/2015 AngioDynamics Morpheus Smart Medical Recall Class II Hospital
PICC CT (Central venous Device
catheters)
23/03/2015 Hydrophilic Acrylic Single Use Medical Recall Class III Retail
lntraocular Lens system packs Device
20/03/2015 FX CorDiax High-Flux dialysers Medical Recall for Class I Hospital
and FX CorDiax Haemodiafilters Device Product
Correction
19/03/2015 Artis Q/Q.zen systems Medical Recall for Class II Hospital
Device Product
Correction
19/03/2015 Catalys Precision Laser System Medical Recall for Class II Hospital
Device Product
Correction
19/03/2015 Divercleanse 750ml Medical Recall Class II Retail
Device
19/03/2015 Hemodialysis Monitor Medical Recall Class II Hospital
Device
19/03/2015 Model 5392 Dual-Chamber Medical Recall for Class I Hospital
External Pulse Generator Device Product
Correction
19/03/2015 RaySearch RayStation 3.5, Medical Recall for Class II Hospital
RayStation 4.0, RayStation 4.5, Device Product
and RayStation 4.7 (Radiation Correction
therapy treatment planning
system)
19/03/2015 T2100 Treadmill Medical Recall for Class II Retail
Device Product
Correction
18/03/2015 Persona Trabecular Metal Tibial Medical Hazard Alert Class II Hospital
Plate, all sizes Device
17/03/2015 Cobas c 501 / c 502 and COBAS Medical Recall Class II Hospital
INTEGRA. An in vitro diagnostic Device

Datei Levelvi
17/03/2015 METAL SHELL, CEM.LESS Medical Hazard Alert Class II Hospital
‘DeltaLox’ SCREW FIX., TiNb- Device
COAT (Acetabular shell
component used for hip
replacement)
16/03/2015 Aiming Arm 125deg and Aiming Medical Recall Class II Hospital
Arm 130deg for TFN- Device
ADVANCED (TFNA) System
16/03/2015 Patient Specific Medicine Recall Class II Hospital
Radiopharmaceuticals
13/03/2015 Access 2 Immunoassay Systems Medical Recall for Class I Hospital
Device Product
Correction
13/03/2015 Brilliance CT 64-channel with Medical Recall for Class II Hospital
Essence technology, Brilliance Device Product
iCT, Brilliance iCT SP, Ingenuity Correction
Ingenuity Elite and Ingenuity CT
13/03/2015 EXACTRAC 6.x (Image Guided Medical Recall for Class I Hospital
RadiationTherapy Patient Device Product
Positioning System) Correction
13/03/2015 Remote controls for JUPITER, Medical Recall for Class II Hospital
ARTIS and TruSystem 7500 Device Product
operating tables Correction
13/03/2015 VITROS 5,1 FS Chemistry Medical Recall for Class II Hospital
Systems using Software Version Device Product
2.8 & Below. An in vitro Correction
12/03/2015 Getinge 46-Series Washer Medical Recall for Class I Hospital
Disinfector with PACS 300/350 Device Product
Correction
12/03/2015 IMMULITE 2000/IMMULITE Medical Recall for Class II Hospital
2000 XPi water and liquid waste Device Product
bottles Correction
12/03/2015 Kenex ceiling-suspended Medical Recall for Class I Hospital
radiation shields and surgical Device Product
lamps Correction
11/03/2015 Inserter f/TEN Medical Recall for Class II Hospital
Device Product
Correction
11/03/2015 Q Vax Skin Test Medicine Recall Class II Retail
6/03/2015 Dostinex (cabergoline), Cabaser Medicine Recall for Class II Consumer
(cabergoline) & Methoblastin Product
(methotrexate) - All Batches Correction
6/03/2015 ONLINE DAT Cannabinoids II / Medical Recall Class III Hospital
100 tests / 200 tests Device
6/03/2015 Signature Orthopadics' Logical Medical Recall Class II Hospital
Ceramic Liner (for use with hip Device
replacement systems)
6/03/2015 Sonidet – Medical Equipment & Medical Recall Class II Hospital
Instrument Detergent Device
5/03/2015 DePuy Synthes Trauma Medical Recall Class II Hospital
DHS/DCS Impactor Tip Device

Datei Levelvi
5/03/2015 HALCION (triazolam) & Medicine Recall Class II Consumer
PONSTAN (mefenamic acid) &
XANAX (alprazolam) - All
Batches
5/03/2015 Self-Righting Luer Slip Tip Cap, Medical Recall for Class III Hospital
Yellow in the DISCPAC Device Product
packaging Correction
3/03/2015 AQUAPAK BRITISH and INTL Medical Recall Class II Hospital
340 SW, 340 ML W/040B Device
Humidifier Adaptors
3/03/2015 Edwards Lifesciences Heart Medical Recall Class II Hospital
Reference Sensor Device
2/03/2015 Cure Sleeve (a dental barrier Medical Recall Class II Retail
sleeve for curing light to prevent Device
cross contamination)
2/03/2015 PVC TUBING X-RAY (includes Medical Recall Class I Hospital
an x-ray detectable line and is Device
used for securing the perfusion
lines during cardiopulmonary
bypass)
27/02/2015 ARCHITECT Anti-HBc II Medical Recall Class II Hospital
Reagent Kit. An in vitro Device
26/02/2015 BD Q-Syte Luer Access Split Medical Recall Class I Hospital
Septum Device Device
26/02/2015 SANDEL Weighted Safety Medical Recall Class II Hospital
Scalpels Device
25/02/2015 Bead Block (Embolic Bead) Medical Recall for Class II Hospital
Device Product
Correction
25/02/2015 RT12 Tube Rotor-Kit (RT12) & Medical Recall for Class II Hospital
StatSpin MP Centrifuge (SSMP) Device Product
Correction
24/02/2015 GENESIS II KNEE SYSTEM – Medical Hazard Alert Class II Hospital
Non Porous Tibial Base Plate Device
24/02/2015 LFIT V40 Femoral Head Medical Hazard Alert Class II Hospital
Device
24/02/2015 Philips Anaesthesia Machines Medical Recall for Class I Hospital
Siesta i Breasy, Siesta i Whispa, Device Product
Dameca MRI 508, Siesta i TS & Correction
IntelliSave AX700
24/02/2015 Triathlon Distal Capture Medical Recall for Class II Hospital
Assembly Device Product
Correction
23/02/2015 GemLock Long Hex Driver Medical Recall Class II Hospital
Device
23/02/2015 Philips Anaesthesia Machines Medical Recall for Class II Hospital
IntelliSave AX700, Dameca MRI Device Product
508, Siesta i Whispa, Siesta iTS Correction
& Siesta Breasy
23/02/2015 XALKORI (crizotinib 200 mg and Medicine Recall for Class III Retail
250 mg) Capsules Product
Correction

Datei Levelvi
Monitor/Defibrillators Device Product
Correction
20/02/2015 ROPIVACAINE PFIZER Solution Medicine Recall Class II Hospital
for Injection 400 mg/200 mL and
200 mg/100 mL bags
19/02/2015 Intuitive Harmonic ACE Medical Recall for Class II Hospital
Instruments (used with the da Device Product
Vinci Standard, S, and Si Correction
Surgical Systems)
18/02/2015 IMMULITE 2000 and IMMULITE Medical Recall for Class II Hospital
2000 XPi - GI-MA (CA 19-9) Device Product
Positive Bias. An in vitro Correction
18/02/2015 LiNA Xcise Laparoscopic Medical Recall for Class II Hospital
Morcellator Device Product
Correction
18/02/2015 T2100 and T2000 Treadmill Medical Recall for Class I Hospital
power cords Device Product
Correction
18/02/2015 VITEK 2 system version 7.01. An Medical Recall for Class III Hospital
(IVD) Correction
17/02/2015 5mm and 8mm Harmonic ACE Medical Recall for Class III Hospital
Instruments IFU (for use with Device Product
5mm Harmonic ACE instruments Correction
(PNs 400274 and 400275)
17/02/2015 AQUARIUS Regional Citrate Medical Recall for Class I Hospital
Anticoagulation (RCA) Device Product
Hemofiltration Device Correction
17/02/2015 Medicina Orange Enteral Medical Recall Class II Hospital
Feeding Pump (MD-OP900) Device
17/02/2015 Radiometer ABL90Flex Medical Recall for Class I Hospital
analysers running V3.1MR1 or Device Product
below Correction
13/02/2015 Allura Xper R7.2.x (Fluoroscopic Medical Recall for Class II Hospital
diagnostic x-ray system) Device Product
Correction
12/02/2015 CARDIOHELP Perfusion Medical Recall for Class III Hospital
System, Software versions prior Device Product
to 3.4.6.0 Correction
12/02/2015 Elecsys CMV IgM assay Medical Recall for Class II Hospital
(04784618190) - Diluent Device Product
Universal. An in vitro diagnostic Correction
11/02/2015 PlasmaSORD Medical Recall for Class II Hospital
Device Product
Correction
11/02/2015 Proteus XR/a X-ray imaging Medical Recall for Class I Hospital
systems manufactured with wall Device Product
stand model number 2260354. Correction

Datei Levelvi
10/02/2015 ADVIA Chemistry 1800 and 2400 Medical Recall for Class III Hospital
Instructions For Use (IFU) Device Product
Updates. An in vitro diagnostic Correction
10/02/2015 Amulet (FDR MS-1000), Amulet f Medical Recall for Class II Hospital
(FDR MS-2500) & Amulet Device Product
Innovality (FDR MS-3500) with Correction
Biopsy Unit
10/02/2015 Drill set long, drill stop Medical Recall Class II Hospital
compatible for D 4.8mm Implant Device
Testing Discs TIM85(Timentin), Device
CT0449B
10/02/2015 Prosthesis, internal, spine, disc Medical Recall Class II Hospital
Device
10/02/2015 VaccZyme Anti-Haemophilus Medical Recall for Class III Hospital
Influenzae B Device Product
Correction
10/02/2015 Zenith Alpha Thoracic Medical Hazard Alert Class I Hospital
9/02/2015 Morce Power Plus 2307 Medical Recall for Class II Hospital
Device Product
Correction
6/02/2015 Acutronic Fabian HFO (High Medical Recall for Class I Hospital
Frequency Oscillation) Device Product
Ventilators , software versions Correction
below GUI 3.0.2.7
6/02/2015 Allura Systems: Field extensions Medical Recall for Class I Hospital
Vascular R7.6 Device Product
Correction
6/02/2015 Cobas EGFR MutationTest Kit Medical Recall Class II Hospital
Device
6/02/2015 Engstrom Carestation and Medical Recall for Class I Hospital
Engstrom Pro Ventilators (that Device Product
were provided with an accessory Correction
cart as part of the original order)
6/02/2015 GE Healthcare MRI systems with Medical Recall for Class I Hospital
superconducting magnets Device Product
Correction
6/02/2015 Invacare PerfectO2 Oxygen Medical Recall for Class I Consumer
Concentrator Device Product
Correction
6/02/2015 M2a 38 Acetabular Cup, M2a 38 Medical Hazard Alert Class II Hospital
Femoral Head, M2a Magnum Device
Tri-Spike Acetabular Cup & M2a
Magnum Femoral Heads
6/02/2015 qube Compact Monitor & Medical Recall for Class II Hospital
XPREZZON Bedside Monitor Device Product
Correction
5/02/2015 CARDIOSAVE Hybrid Intra- Medical Recall for Class I Hospital
Aortic Balloon Pump (IABP) Device Product
Correction

Datei Levelvi
4/02/2015 AK 200 S and AK 200 ULTRA S Medical Recall for Class I Consumer
nocturnal home hemodialysis Device Product
machines Correction
4/02/2015 AKINETON, biperiden Medicine Recall Class II Consumer
hydrochloride
4/02/2015 Colaspase 10iu in 1mL 0.9% Medicine Recall Class I Hospital
Sodium Chloride
4/02/2015 VITEK 2 System version 7.01. Medical Recall for Class II Hospital
device (IVD). Correction
3/02/2015 ADVIA Centaur Systems Medical Recall for Class III Hospital
Progesterone Kits Device Product
Correction
3/02/2015 Birmingham Hip Resurfacing Medical Hazard Alert Class II Hospital
(BHR) System Device
3/02/2015 CDAS upgraded Intera MR Medical Recall for Class I Hospital
systems equipped with the Basic Device Product
Triggering Unit Correction
3/02/2015 IntelliSpace Critical Care & Medical Recall for Class I Hospital
Anaesthesia Information Device Product
Systems Correction
3/02/2015 SIM System with SIM dock Medical Recall for Class I Retail
power supply model Franmar Device Product
FRA012-S05-I Correction
2/02/2015 Puritan Bennett 980 Series Medical Recall for Class II Hospital
Ventilator System Device Product
Correction
30/01/2015 Airlight ROM brace (An Orthosis Medical Recall for Class II Hospital
that encompases the knee joint) Device Product
Correction
30/01/2015 CADD Medication Cassette Medical Recall Class II Hospital
Reservoir, 50ml Device
30/01/2015 DuraDiagnost X-ray System Medical Recall for Class I Hospital
Device Product
Correction
30/01/2015 NEO-MERCAZOLE, Medicine Recall Class II Retail
carbimazole, 5mg tablets
30/01/2015 Philips IntelliVue Information Medical Recall for Class I Hospital
Center (PIIC) iX system (A Device Product
Centralized Patient Monitoring Correction
System)
30/01/2015 Siemens Capillary Caps for Medical Recall for Class II Hospital
RAPIDLyte Multicap and Device Product
Multicap-S Blood Collection Correction
Capillaries
29/01/2015 CS 8100 & CS 8100 3D Medical Recall for Class I Retail
Device Product
Correction
29/01/2015 DigitalDiagnost Release 4.0.0. Medical Recall for Class III Hospital
and 4.0.1 Device Product
Correction

Datei Levelvi
29/01/2015 Medtronic Minimed 640G Medical Recall for Class II Consumer
Infusion Pump used in clinical Device Product
trials Correction
29/01/2015 MultiDiagnost Eleva Flat Medical Recall for Class II Hospital
Detector (FD) System Device Product
Correction
29/01/2015 MultiDiagnost Eleva II/TV Medical Recall for Class II Hospital
Correction
29/01/2015 Various Sterile-Packaged Medical Recall Class II Hospital
Femoral Heads (Various sizes, Device
neck lengths and taper sizes)
28/01/2015 ADVIA Chemistry Systems Drug Medical Recall for Class II Retail
Calibrator I for Phenytoin 2 and Device Product
Phenobarbital 2 Assays. An in Correction
vitro Diagnostic Medical Device.
28/01/2015 Brilliance iCT and Brilliance iCT Medical Recall for Class II Hospital
SP with software versions Device Product
4.1.0.xxxxx, or 4.1.1.xxxxx, or Correction
4.1.2.xxxxx
23/01/2015 Brainlab Offset Cup Impactor Medical Recall for Class I Hospital
Universal Device Product
Correction
23/01/2015 InterStim & InterStim II Medical Hazard Alert Class II Hospital
Device
22/01/2015 Artis Dialysis System equipped Medical Recall for Class I Hospital
with SW 8.15.06 and 8.33.02 Device Product
Correction
22/01/2015 FORUM Software Medical Recall for Class I Retail
Device Product
Correction
22/01/2015 MiniCap with Povidone-Iodine Medical Recall Class I Consumer
Solution Device
22/01/2015 Xcela PICC with PASV Valve Medical Recall Class II Hospital
Technology/Kits, BioFlo PICC Device
with Endexo and PASV Valve
Technology/Kits
20/01/2015 Aequalis Ascent Flex Reversed Medical Recall Class II Wholesale
Cut Guide (Instrument for use in Device
the implantation of joint
prostheses)
20/01/2015 Integra Mayfield Ultra 360 Base Medical Recall for Class I Hospital
Unit Device Product
Correction
20/01/2015 Medicina DS03 Silo Dressing Medical Recall Class II Hospital
3.0mm – DS04 Silo Dressing Device
4.0mm – DS05 Silo Dressing
5.0mm – DS06 Silo Dressing
6.0mm
20/01/2015 Medicina Keyhole Dressing Medical Recall Class II Hospital
KDXX Device
20/01/2015 PharmAust 30ml Chlorhexidine Medical Recall Class III Hospital
in Ethanol 70% (Red Tint) Device

Datei Levelvi
20/01/2015 System 6 Aseptic Battery Kit Medical Recall for Class I Hospital
Device Product
Correction
Correction
19/01/2015 Medicina Low Profile Medical Recall Class II Hospital
Gastrostomy Button Device
19/01/2015 Medicina Nasogastric Plaster Medical Recall Class III Hospital
NS01 (Nasal Strip) Device
19/01/2015 Medicina SILOBAG Medical Recall Class II Hospital
Device
19/01/2015 PowerLED, Hied, Xten, Standop Medical Recall for Class II Hospital
Volista, Hanaulux 3000 range - Device Product
SA Ceiling Suspension Correction
19/01/2015 Single Limb Circuit for Pneupac Medical Recall Class I Hospital
Ventilators, with PEEP Valve Device
16/01/2015 MEDPOR Barrier Sheets – Medical Recall Class II Hospital
Orbital Floor Implant 38mm X Device
50mm X 1.6mm
16/01/2015 SONY LMD-1951MD Medical Recall for Class I Hospital
MONITORS Device Product
Correction
15/01/2015 Persona (TASP) Tibial Articular Medical Recall for Class II Hospital
Surface Provisional Shim Device Product
Correction
15/01/2015 syngo.plaza Medical Recall for Class I Hospital
Device Product
Correction
14/01/2015 Brilliance CT 16 Air, 64, Big Medical Recall for Class I Hospital
Bore, iCT, iCT SP, Ingenuity CT, Device Product
Ingenuity Core, Ingenuity Correction
Core128 and Ingenuity Flex
14/01/2015 Hand-held Barcode Scanner Medical Recall for Class I Hospital
used with VITROS clinical Device Product
chemistry systems. An in vitro Correction
9/01/2015 Maquet demonstration unit fiber- Medical Recall for Class II Hospital
optic Intra-Aortic Balloon Device Product
Catheter Correction
7/01/2015 da Vinci Standard Surgical Medical Recall for Class I Hospital
System, da Vinci S Surgical Device Product
System, da Vinci Si Surgical Correction
System, da Vinci Si-e Surgical
System including all instruments
and accessories used with the
da Vinci surgical systems
7/01/2015 HeartWare Controller Medical Recall Class I Hospital
Device
7/01/2015 Virazole (ribavirin powder for Medicine Recall Class I Hospital
solution)

Datei Levelvi
24/12/2014 Anti-dsDNA Kit. An in vitro Medical Recall for Class III Hospital
Correction
24/12/2014 Cheek Retractor, Medical Recall Class II Hospital
f/MatrixMANDIBLE U-shaped, Device
flexible
24/12/2014 Minor Plastics Pack IVF Australia Medical Recall Class II Hospital
Device
24/12/2014 Monaco (radiation therapy Medical Recall for Class II Hospital
planning system) Device Product
Correction
24/12/2014 Radiometer ABL90Flex Medical Recall for Class I Hospital
analysers running V3.1MR1 or Device Product
below Correction
23/12/2014 Bending/Cutting Pliers with Medical Recall Class II Hospital
Nose, for LOCK Plates 2.0 Device
23/12/2014 Dimetapp Daytime/Nightime Medicine Recall Class II Retail
Liquid Caps capsule blister pack
23/12/2014 Enzymatic Creatinine, Medical Recall for Class I Hospital
Cholesterol, Uric Acid, Lactate, Device Product
and Lipase Assays Correction
23/12/2014 Focal Release 4.80.00 Medical Recall for Class II Hospital
Device Product
Correction
23/12/2014 MEVATRON, PRIMUS, ONCOR Medical Recall for Class II Hospital
and ARTISTE Digital Linear Device Product
Accelerators Correction
23/12/2014 NCL-L-CD15. An in vitro Medical Recall Class I Hospital
22/12/2014 Affinis Inverse inlay ceramys & Medical Recall for Class II Hospital
Affinis Fracture ceramic heads Device Product
(Total Shoulder System that is Correction
designed for treating shoulder
conditions)
19/12/2014 Basic Custom Procedure Pack Medical Recall for Class III Hospital
Device Product
Correction
19/12/2014 PF4 IgG assay (Thrombophilia Medical Recall Class II Hospital
and coagulation inhibitor assay). Device
An in vitro Diagnostic Medical
Device (IVD).
19/12/2014 RF enabled St. Jude Medical Medical Hazard Alert Class II Hospital
Ellipse, Fortify Assura, Unify Device
Assura, and Quadra Assura
Implantable Cardioverter
Defibrillators (ICDs) and Assurity
and Allure Pacemakers when
used with Merlin@home RF
Remote Monitoring Transmitter
Model EX1150
19/12/2014 Sensei X Robotic Catheter Medical Recall for Class I Hospital
Correction

Datei Levelvi
19/12/2014 Trellis 8 Peripheral Infusion Medical Recall for Class I Hospital
Correction
19/12/2014 Triathlon Tibial Alignment Ankle Medical Recall for Class II Hospital
Clamp EM Device Product
Correction
18/12/2014 EndoBarrier Gastrointestinal Medical Hazard Alert Class II Hospital
Liner with Delivery System Device
18/12/2014 Fluoron Gas Tamponade Medical Recall Class II Hospital
EasyGas SF6 Device
18/12/2014 Jurnista 16 MG 14 Tablets Medicine Recall Class II Retail
18/12/2014 LENTIS HydroSmart Foldable Medical Hazard Alert Class II Hospital
Intraocular Lenses in Glass Vials Device
Correction
17/12/2014 Saw Palmetto 4600 Medicine Recall Class III Retail
16/12/2014 Alere Actim Partus. An in vitro Medical Recall for Class II Hospital
Correction
16/12/2014 Captia Malaria EIA (An in vitro Medical Recall for Class II Hospital
Diagnostic Medical Device (IVD)) Device Product
Correction
16/12/2014 Depuy Synthes Trauma RIA Medical Recall Class II Hospital
(Reamer/Irrigator/Aspirator) Device
system
15/12/2014 Cartia LOW DOSE ASPIRIN Medicine Recall Class III Retail
100mg tablet blister 7's pack
15/12/2014 Ysio Max, Luminos dRF Max and Medical Recall for Class II Hospital
Luminos Agile Max (with Device Product
software version VE10 including Correction
SmarthOrtho license)
12/12/2014 AQT90Flex TnI (troponin) Test Medical Recall Class II Hospital
device (IVD).
12/12/2014 Artis Q and Artis Q.zen Ceiling Medical Recall for Class II Hospital
Systems (Fluoroscopic Device Product
angiographic x-ray system)) Correction
12/12/2014 Artis Zeego Systems Medical Recall for Class II Hospital
(Fluoroscopic angiographic x-ray Device Product
system) Correction
12/12/2014 HemosIL PT-Fibrinogen HS Medical Recall Class I Hospital
PLUS, An in-vitro diagnostic Device
12/12/2014 Proteus XR/a X-ray Imaging Medical Recall for Class II Hospital
Correction

Datei Levelvi
11/12/2014 iPlan RT / iPlan RT Dose Medical Recall for Class I Hospital
Radiation Treatment Planning Device Product
Software used in combination Correction
with a localiser and one of the
positioning solutions Target
Positioner, ExacTrac v.4.5 or
v.5.x, ExacTrac Vero (versions
2.1, 3.0, 3.1, 3.1.1, 3.2.0, 3.2.1)
11/12/2014 Phadia 1000 Instrument (Allergy Medical Recall for Class II Hospital
testing system). An in vitro Device Product
10/12/2014 Alere INRatio & INRatio2 PT/INR Medical Recall for Class I Consumer
Monitor System. An in vitro Device Product
10/12/2014 Eon Mini Implantable Pulse Medical Recall Class I Hospital
Generator (IPG) Model 65-3788 Device
and Eon Mini Charging System
Model 3721
10/12/2014 Eon/Eon C/ Eon Mini/ Prodigy Medical Hazard Alert Class II Hospital
Neurostimulation Systems and Device
Octrode/ Quattrode
Percutaneous Leads and
Accessories
10/12/2014 Philips M1783A and M5526A 12 Medical Recall for Class I Hospital
Pin Sync Cables Device Product
Correction
10/12/2014 QIAsymphony DSP Medical Recall Class II Hospital
Virus/Pathogen Midi Kit. An in Device
vitro Diagnostic Medical Device
(IVD)
Correction
9/12/2014 Synthes Small Electric Drive Medical Recall Class II Hospital
Hand Piece (Drill Surgical Device
System)
8/12/2014 Humeral broaches Aequalis Medical Recall Class II Hospital
(6/6.5 diameter) Device
Monitor/Defibrillators Device Product
Correction
Correction
5/12/2014 Trilogy Bone Screws – 6.5mm X Medical Hazard Alert Class II Hospital
35mm & 6.5mm X 25mm Device
4/12/2014 Defibrillation Electrode for Medical Recall Class I Hospital
Children (Leonhard Lang) used Device
with GE defibrillators
4/12/2014 DRX Revolution Mobile X-Ray Medical Recall for Class I Hospital
Correction

Datei Levelvi
4/12/2014 i-Optics’ Cassini, Corneal Medical Recall for Class II Hospital
Topographer, with a recent Device Product
software upgrade to version Correction
2.0.0
4/12/2014 Philips HeartStart MRx Medical Recall for Class II Hospital
Correction
4/12/2014 Sirius Polish Cemented Stem Medical Hazard Alert Class II Hospital
34B & Sirius Polish Cemented Device
Stem 38C
4/12/2014 Stryker Laparoscopic Manual Medical Recall for Class II Hospital
Instruments and Accessories Device Product
Correction
2/12/2014 3i T3, Full Osseotite Tapered & Medical Recall Class II Retail
Parallel Walled Dental Implants Device
28/11/2014 AtriCure CryoICE cryo-ablation Medical Recall Class I Hospital
probe (CRYO2) Device
28/11/2014 DBL (TM) Mitoxantrone Medicine Recall Class II Hospital
Hydrochloride Injection
Concentrate 20mg/10mL
injection vial
28/11/2014 SpermMar IgA (Fertipro) (Test Medical Recall Class III Hospital
for sperm antibodies against IgA) Device
28/11/2014 VITROS 3600 Immunodiagnostic Medical Recall for Class II Hospital
Systems, VITROS 4600 Device Product
Chemistry Systems & VITROS Correction
5600 Integrated Systems,
Software Versions 3.1 & Below
27/11/2014 BrightView SPECT, BrightView X Medical Recall for Class I Hospital
and BrightView XCT Software Device Product
Correction
27/11/2014 BrightView SPECT, BrightView X Medical Recall for Class I Hospital
and BrightView XCT Systems Device Product
Correction
27/11/2014 DX-D 600 X-ray System, Medical Recall for Class I Hospital
Versions below 3.6 Device Product
Correction
27/11/2014 EPIQ 7 V1.0.x/1.1.x with QLAB Medical Recall for Class I Hospital
a2DQ and/or aCMQ plug-ins Device Product
Correction
27/11/2014 EPIQ5 Vi .0.x/1 .1 .x with QLAB Medical Recall for Class I Hospital
a2DQ and/or aCMQ plug-ins Device Product
Correction
27/11/2014 FAKWP (Fineline 6100258) and Medical Recall Class II Retail
FAKSITE (Fineline 5820595) Device
First Aid Kits
27/11/2014 LumaDent Light Battery Packs Medical Recall Class II Hospital
Device
27/11/2014 Philips Ultrasound QLAB Medical Recall for Class I Hospital
versions 10 and 10.1 .x with Device Product
a2DQ and/or aCMQ plug-ins Correction

Datei Levelvi
27/11/2014 Philips Ultrasound Q-Station 3.0 Medical Recall for Class I Hospital
with a2DQ and/or aCMQ Q-Apps Device Product
Correction
26/11/2014 Iron Plus Capsules Medicine Recall Class III Wholesale
26/11/2014 KimVent Microcuff Subglottic Medical Recall Class I Hospital
Suctioning Endotracheal Tube, Device
7.0 mm, 7.5 mm, 8.0 mm, 8.5
mm & 9.0 mm
26/11/2014 PF Saline Nasal Spray 30ml Medicine Recall Class II Retail
24/11/2014 syngo Imaging XS and Medical Recall for Class II Hospital
syngo.plaza (Radiology picture Device Product
archiving and communication Correction
system)
21/11/2014 Biograph mCT and Biograph Medical Recall for Class I Hospital
mCT Flow systems running Device Product
VG50A software and equipped Correction
with the Adaptive 3D Intervention
option
21/11/2014 Esprit V1000 and Esprit/V200 Medical Recall for Class I Hospital
Conversion Ventilator Device Product
Correction
21/11/2014 IMMULITE 2000 and IMMULITE Medical Recall Class II Hospital
2000 XPi Device
21/11/2014 LIAISON Borrelia IgG. An in vitro Medical Recall Class II Hospital
21/11/2014 McGRATH MAC Video Medical Recall Class I Hospital
Laryngoscope Blade Size #2 Device
21/11/2014 Pico 70 Arterial Blood sampler Medical Recall Class I Hospital
Device
21/11/2014 Silane (dentine adhesive) Medical Recall Class II Retail
Device
21/11/2014 Sunrise Medical Sunlift Hoist Medical Recall for Class II Consumer
Device Product
Correction
20/11/2014 BrightView XCT SPECT/CT Medical Recall for Class II Hospital
Correction
20/11/2014 HomeChoice PRO Automated Medical Recall for Class II Hospital
PD System Automated PD Device Product
System Devices Correction
19/11/2014 3f Enable Aortic Bioprosthesis - Medical Hazard Alert Class I Hospital
Model 6000 Device
18/11/2014 Boston Scientific AUTOGEN DR Medical Hazard Alert Class I Hospital
Implantable Cardioveter- Device
Defibrillators (ICDs) and Cardiac
Resynchronization Therapy
Defibrillators (CRT-Ds)
18/11/2014 DePuy Synthes ATTUNE Medical Recall Class II Hospital
Intuition Distal Femoral Jig Device
14/11/2014 AlignRT patient Medical Recall for Class II Hospital
positioning/tracking video Device Product
camera system Correction

Datei Levelvi
14/11/2014 CareLink Clinical Therapy Medical Recall for Class II Hospital
Management Software Device Product
Correction
14/11/2014 Rocket IPC Drainage Bottle (A Medical Recall for Class II Hospital
collection device used to collect Device Product
fluid or air from the pleural Correction
cavity)
13/11/2014 Alcon INFINITI Ultrasound PAKs Medical Recall for Class II Hospital
- INFINITI Microsmooth Tapered Device Product
Kelman 30° Correction
13/11/2014 Alere Determine HIV-1/2 Ag/Ab Medical Recall for Class II Hospital
Combo (an in vitro diagnostic Device Product
medical device) Correction
13/11/2014 Dimension Vista Systems - Medical Recall Class III Hospital
Theophylline (THEO) Flex Device
Reagent Cartridge. An in vitro
13/11/2014 Liquid Specific Protein (LSP) Medical Recall for Class III Hospital
13/11/2014 Revaclear and Revaclear Max Medical Recall Class II Hospital
Dialysers (Hollow-fibre Device
haemodialysis dialyser)
13/11/2014 Stellaris PC with Laser System Medical Recall for Class II Hospital
(Cataract extraction/vitrectomy Device Product
system) Correction
12/11/2014 ArthroCare Corporation HipVac Medical Recall Class II Hospital
50 Coblation Wand Device
12/11/2014 Horse Blood Agar. An in vitro Medical Recall Class III Hospital
Diagnostic Medical Device (IVD) Device
11/11/2014 cCrea A+B Membrane Unit for Medical Recall for Class II Hospital
use on the ABL800 series blood Device Product
gas analyser range Correction
11/11/2014 Elekta X-ray Volume Imaging Medical Recall for Class I Hospital
System (XVI), software versions Device Product
5.0.0 and 5.0.1 (Electronic Correction
Imaging Device (EID) used with
10/11/2014 HemoCue Glucose 201 Medical Recall for Class I Hospital
Microcuvettes single packed Device Product
Correction
10/11/2014 IH-1000 (immuno-haematology Medical Recall for Class I Hospital
instrument). An in vitro Device Product
7/11/2014 Dimension Vista 500 Intelligent Medical Recall for Class II Hospital
Lab System & Dimension Vista Device Product
1500 Intelligent Lab System Correction
7/11/2014 Gelflex Sterile Eye Wash Normal Medical Recall Class II Retail
Saline 10mL Ampoule Device
7/11/2014 STERIS 5085 and 5085SRT Medical Recall for Class II Hospital
Surgical Table Device Product
Correction

Datei Levelvi
6/11/2014 Fisher & Paykel Healthcare Medical Recall for Class I Hospital
Infant Warmer Pivot Securing Device Product
Nut Correction
4/11/2014 Endo Wrist One Vessel Sealer Medical Recall for Class I Hospital
(INS-410322) for the da Vinci Si Device Product
(IS3000) Surgical System Correction
4/11/2014 MammoDiagnost DR Medical Recall for Class II Hospital
Device Product
Correction
31/10/2014 Anaerobic Agar Plate. An in vitro Medical Recall Class II Hospital
31/10/2014 Hamilton Active Family SPF 50+ Medicine Recall Class III Wholesale
225mL
31/10/2014 Relief ACP Oral Care Gel Medical Recall Class II Consumer
supplied separately and in Zm Device
CH 25% Kits
30/10/2014 Mindray V-Series Patient Medical Recall for Class II Hospital
Monitors with 12-lead ECG Device Product
interpretation capabilities Correction
30/10/2014 Mindray's V-Series Patient Medical Recall for Class I Hospital
Monitors, software versions Device Product
2.4.0.18, 2.4.0.50, 2.4.0.60 and Correction
2.4.1.18
30/10/2014 Panorama Central Station, Medical Recall for Class II Hospital
software versions 10.0 to 11.3 Device Product
and patient Monitoring Network Correction
29/10/2014 AFB III Staining Kit (An in vitro Medical Recall for Class II Hospital
diagnostic medical device (IVD)) Device Product
Correction
29/10/2014 Philips IntelliVue Patient Medical Recall for Class I Hospital
Monitors and Philips Avalon Device Product
Fetal Monitors Correction
29/10/2014 TORISEL temsirolimus 25 mg Medicine Recall Class II Hospital
concentrate for injection vial and
diluent vial composite pack
29/10/2014 Zimmer NexGen Trabecular Medical Recall for Class II Hospital
Metal Tibial (Replacement) Device Product
Impactor Pad Instruments Correction
28/10/2014 Thermo Scientific MAS Medical Recall Class II Hospital
CardioImmune XL Device
28/10/2014 ThermoCool SmartTouch Medical Recall for Class I Hospital
Catheter Family (used to Device Product
facilitate electrophysiological Correction
mapping of the heart and to
undertake RF ablations)
24/10/2014 E-Z Gas II Effervescent Granules Medicine Recall Class III Hospital
Antacid/Antiflatulent 4g packet
24/10/2014 Zovirax (aciclovir) Ophthalmic Medicine Recall Class II Retail
Ointment 30mg/g
23/10/2014 AVS PL SPACER (Used as an Medical Recall Class III Hospital
aid in spinal fixation) Device

Datei Levelvi
23/10/2014 Burinex (Bumetanide) Injection Medicine Recall Class II Hospital
2mg/4mL (Pack of 5 ampoules)
23/10/2014 Symbia S and T Series camera Medical Recall for Class II Hospital
systems (SPECT/CT nuclear Device Product
medicine diagnostic imaging Correction
system)
23/10/2014 Thioglycollate Broth 5mL. An in Medical Recall Class II Hospital
(IVD)
21/10/2014 APC Plus Victory Series Twin Medical Recall Class III Retail
Upper Left Cuspid -3T/10A with Device
Distal Hook (Unitek Orthodontic
Metal Brackets - Orthodontic
bracket, metal)
21/10/2014 IMMULITE, IMMULITE 1000, Medical Recall for Class II Hospital
IMMULITE 2000 and IMMULITE Device Product
2000 XPi - Calcitonin Control Correction
Module
20/10/2014 50mm Left Standard Ti Mandible Medical Hazard Alert Class II Hospital
Device
17/10/2014 Artis zeego systems with a C - Medical Recall for Class II Hospital
arm (Fluoroscopic X-ray Device Product
systems) Correction
17/10/2014 Sapphire Administration IV Set Medical Recall for Class II Hospital
AP424 ( Patient Controlled Device Product
Analgesia IV set for use with the Correction
Sapphire infusion pump)
17/10/2014 Surveyor S12 and Surveyor S19 Medical Recall for Class II Hospital
Patient Monitors Device Product
Correction
17/10/2014 UNIVERSAL Modular Medical Recall for Class II Hospital
Electric/Battery Double Trigger Device Product
Handpiece (Surgical power tool) Correction
Centaur XP (An in vitro Device Product
diagnostic medical device (IVD)) Correction
15/10/2014 Dimetapp Saline Nasal Drops for Medical Recall Class II Retail
Infants Device
14/10/2014 Edwards Lifesciences Vent Medical Recall for Class I Hospital
Catheter Device Product
Correction
14/10/2014 Leksell Gamma Knife Perfexion Medical Recall for Class I Hospital
(teletherapy device indicated for Device Product
stereotactic irradiation of head Correction
structures)
10/10/2014 0.9% Sodium Chloride for Medical Recall Class I Hospital
Irrigation 2000ml and Water for Device
Irrigation 2000ml
10/10/2014 Allura Xper Systems Medical Recall for Class I Hospital
Device Product
Correction
10/10/2014 Hudson Nebuliser Adaptor - Medical Recall Class II Hospital
AQUAPAK Device

Datei Levelvi
10/10/2014 Ingenuity CT, Ingenuity Core, Medical Recall for Class I Hospital
Ingenuity Core128 with Device Product
Continuous Computed Correction
Tomography (CCT) Option and
have been upgraded from
Software Version 3.x to Version
4.0.0 / 4.0.1
10/10/2014 MultiDiagnost Eleva with Flat Medical Recall for Class I Hospital
Detector Systems Device Product
Correction
10/10/2014 PHILIPS MX 16-slice CT Medical Recall for Class II Hospital
System, software: v1.1.3.1167; Device Product
v1.1.4.21425; v1.1.4.21424; Correction
v1.1.4.21422
10/10/2014 Small Form Factor Console PC Medical Recall for Class II Hospital
(Used Access 2 Immunoassay Device Product
System and the UniCel DxC 600i Correction
SYNCHRON Access Clinical
10/10/2014 Sodium Chloride For Injection – Medicine Recall Class I Wholesale
MS 0.9% W/V, 50 X 5ML
Ampoules
Correction
9/10/2014 Selector Tubing Kit for use with Medical Recall for Class I Hospital
CUSA Selector Ultrasonic Device Product
Aspirators Correction
8/10/2014 ADVIA Centaur, ADVIA Centaur Medical Recall for Class II Hospital
XP and ADVIA Centaur CP - Device Product
BNP Ready Pack Lot 038174 Correction
8/10/2014 Dimension Vista Systems Mass Medical Recall for Class II Hospital
CKMB Isoenzyme Calibrator Device Product
(MMB CAL). An in vitro Correction
8/10/2014 Multiple ProcedurePak Trays Medical Recall Class II Hospital
with Ecolab-Microtek Medical Device
Basin Liners
Correction
7/10/2014 Abbott RealTime Assay Medical Recall Class II Hospital
Application CD-ROM Device
7/10/2014 Calibrator E used for calibration Medical Recall for Class III Hospital
of the ADVIA Centaur Systems Device Product
Cortisol, Progesterone and Correction
Testosterone assays
7/10/2014 Discovery MR750, Optima Medical Recall for Class I Hospital
MR450w equipped with the GEM Device Product
option, and Discovery MR750w Correction
equipped with the GEM option
products that are running DV 25
software release (MRI System)

Datei Levelvi
7/10/2014 IMRIS Operating Room table Medical Recall for Class I Hospital
(ORT300) Device Product
Correction
3/10/2014 AMPLITUDE Orthopaedic Medical Recall for Class II Hospital
Surgical Instruments Device Product
Correction
3/10/2014 Lifemed Urinary Drainage Bag Medical Recall Class II Hospital
with Pump Device
3/10/2014 OEC 9800, OEC UroView 2800, Medical Recall for Class I Hospital
OEC MiniView 6800, OEC Device Product
FlexiView 8800 (mobile Correction
flouroscopic x-ray diagnostic
system)
2/10/2014 CLINITEK Status, CLINITEK Medical Recall for Class II Hospital
Status+, and CLINITEK Status Device Product
Connect Systems Correction
2/10/2014 COLGATE TOTAL ORIGINAL Medicine Recall Class III Consumer
toothpaste tube 220g
1/10/2014 Accu-Chek Spirit Combo Insulin Medical Recall for Class I Consumer
Correction
1/10/2014 Autostainer Link 48, AS480 Medical Recall for Class II Hospital
Device Product
Correction
1/10/2014 Proclear Toric Soft Hydrophilic Medical Recall Class II Retail
Contact Lenses Device
1/10/2014 Trident Acetabular System Medical Recall for Class II Hospital
Hemispherical Surgical Protocol Device Product
& Product Reference Guide Correction
30/09/2014 Panbio Q Fever IgM ELISA (An Medical Recall Class II Hospital
(IVD))
26/09/2014 MENINGITEC meningococcal Medicine Recall Class II Retail
serogroup C conjugate vaccine
suspension for injection pre-filled
syringe
26/09/2014 Multiple Models of GE Nuclear Medical Recall for Class II Hospital
Medicine Systems: Device Product
Correction
26/09/2014 Persona Distal Valgus Alignment Medical Recall for Class II Hospital
Guide (supplied as part of the Device Product
reusable surgical kit) Correction
26/09/2014 Zimmer Persona Tibial Articular Medical Recall for Class II Hospital
Surface Provisional (TASP) Device Product
Instruments Correction
25/09/2014 Aeroneb Pro and Solo Nebuliser Medical Recall for Class I Hospital
Systems - FRIWO power adapter Device Product
Correction

Datei Levelvi
systems (software versions Device Product
VC14 and VC21) with the A100 Correction
generator and specific
manufacturing lots of 3 focal spot
x-ray tube (fluoroscopic
angiographic x-ray system)
25/09/2014 Covidien Medi-Trace Cadence Medical Recall for Class I Hospital
Defibrillation Electrodes Device Product
Correction
25/09/2014 Dimension Vista Hemoglobin Medical Recall Class II Hospital
A1c Flex Reagent Cartridge. An Device
(IVD)
25/09/2014 Stereo Biopsy Device used with Medical Recall for Class II Hospital
Mammomat Inspiration Device Product
Mammography System Correction
24/09/2014 BOC Medical Grade Medicine Recall Class II Hospital
Compressed Air supplied in Size
D Cylinders
24/09/2014 Expression Information Portal - Medical Recall for Class II Hospital
IP5 (secondary display control Device Product
unit for Expression MRI patient Correction
monitoring system)
24/09/2014 Grifols Australia Perfect Panel Medical Recall for Class I Hospital
cells Device Product
Correction
24/09/2014 IMMULITE/IMMULITE 1000 - Medical Recall Class I Hospital
Cortisol Assay - An in vitro Device
22/09/2014 AcrySof CACHET PHAKIC Lens Medical Hazard Alert Class I Hospital
Device
22/09/2014 Codman Neuro EDS 3 CSF Medical Recall Class I Hospital
External Drainage Systems Device
22/09/2014 COGNIS Implantable Cardiac Medical Hazard Alert Class I Hospital
Resynchronization Therapy Device
Defibrillators (CRT-Ds) and
TELIGEN DR & VR Implantable
Cardioverter -Defibrillators
(ICDs)
22/09/2014 Premise Universal Restorative Medical Recall Class III Retail
Body Syringe and Unidose, Device
Shade A2
19/09/2014 SwitchPoint Infinity 3 - SPI3 Medical Recall for Class III Hospital
Device Product
Correction
18/09/2014 Aeroneb Pro/Solo Nebuliser Medical Recall for Class I Hospital
Systems FRIWO power adapter Device Product
Correction
18/09/2014 m24sp Instrument System Medical Recall for Class II Hospital
(sample extraction system). An Device Product
(IVD)

Datei Levelvi
18/09/2014 Salfo Talaris Tibial Impactor Medical Recall for Class II Retail
Device Product
Correction
17/09/2014 ADVIA Centaur/Centaur Medical Recall Class II Hospital
XP/Centaur CP Systems HBc Device
Total (HBcT) Assay
17/09/2014 VITROS 4600 Chemistry Medical Recall for Class II Hospital
Systems & VITROS 5600 Device Product
Integrated Systems Using Correction
Software Version 3.0
16/09/2014 ADVIA Centaur Cleaning Medical Recall Class III Hospital
Solution. An in vitro diagnostic Device
16/09/2014 NaCl, Enzyme Test and Cold Medical Recall Class II Hospital
Agglutinins Device
16/09/2014 VIDAS Anti HBs Total II. An in Medical Recall for Class III Hospital
vitro Diagnostic Medical Device Device Product
(IVD) Correction
15/09/2014 942-073, D8088_Crea A, Medical Recall Class III Hospital
D8089_Crea B Membranes used Device
on the ABL827 blood gas
15/09/2014 Defibrillator/pacer SLIM corpuls3 Medical Recall for Class I Retail
Device Product
Correction
15/09/2014 Human IgG4 Kit Immage Kit Medical Recall for Class II Hospital
Device Product
Correction
15/09/2014 Optional PS500 External Power Medical Recall for Class I Hospital
Supply Unit Used in connection Device Product
with Dräger V Series Ventilators Correction
15/09/2014 Puritan Bennett 840 Ventilator Medical Recall for Class I Hospital
Device Product
Correction
15/09/2014 Ysio Max, Luminos dRF Max, Medical Recall for Class II Hospital
Luminos Agile Max, Uroskop Device Product
Omnia Max with software version Correction
VE10A to VE10C
12/09/2014 Dade Innovin Reagent. An in Medical Recall for Class II Hospital
(IVD) Correction
12/09/2014 Phenocell A 3%. An in vitro Medical Recall for Class II Hospital
Correction
11/09/2014 IntelliSpace Portal, software Medical Recall for Class I Hospital
versions 5.0.0, 5.0.1, 5.0.2, Device Product
6.0.0, 6.0.1, 6.0.2 Correction
10/09/2014 DePuy Charnley Pin Retractor & Medical Recall Class II Hospital
Handle Set (orthopaedic hip joint Device
replacement instrument)

Datei Levelvi
9/09/2014 Babytherm 8004/8010 and Medical Recall for Class I Hospital
Babytherm 8000WB for Device Product
newborns (Infant warmers and Correction
open infant care units)
9/09/2014 Pinnacle3, software versions 9.0, Medical Recall for Class I Hospital
9.2. 9.4, 9.6 (Radiation Device Product
Treatment Planning System) Correction
5/09/2014 MobileDiagnost wDR (Mobile Medical Recall for Class II Hospital
digital x-ray imaging system) Device Product
Correction
5/09/2014 Phenocell A 3%. An in vitro Medical Recall for Class II Hospital
Correction
5/09/2014 Spectra Optia Apheresis System Medical Recall for Class I Hospital
with Software Version 11 Device Product
Correction
5/09/2014 Ysio Systems with fixed detector Medical Recall for Class II Hospital
in the wall stand, software Device Product
version VC10 (Diagnostic digital Correction
x-ray system)
4/09/2014 Horizon Cardiology Hemo – Medical Recall for Class I Hospital
versions 13.0 and 13.1 Device Product
(cardiology/cath lab information Correction
management system)
3/09/2014 Scherbak Weights – 400 gr and Medical Recall Class II Hospital
800 gr (used with Scherbak Device
vaginal speculum)
3/09/2014 Vision Sciences Battery Charger Medical Recall Class II Hospital
(VANSON V-95) and Device
rechargeable Lithium-Ion
Batteries supplied with BLS-1000
portable LED light source kits or
as standalone items. (Light
Source for endoscopic
procedures)
2/09/2014 IntelliSpace PACS 4.4 Medical Recall for Class I Hospital
(Radiology picture archiving and Device Product
communication system) Correction
2/09/2014 Intuitive Surgical Battery Box of Medical Recall for Class II Hospital
the da Vinci STM and da Vinci Device Product
SiTM Surgical Systems Correction
1/09/2014 ZOLL ProPadz Sterile Multi- Medical Recall Class II Hospital
Function Electrodes Device
29/08/2014 4D Integrated Treatment Medical Recall for Class I Hospital
Console (4DITC) Version: 10 Device Product
and 11 (Used for accurate Correction
treatment delivery by monitoring
linear accelerator parameters)
29/08/2014 Bard DuaLok Breast Lesion Medical Recall Class II Hospital
Localization Wire Device
29/08/2014 Cortex Screw Ø 3.5 mm, self- Medical Recall Class II Hospital
tapping, length 28 mm, Stainless Device
Steel
29/08/2014 Maintenance Solution Amino Medicine Recall Class II Hospital
Acid 4% + Heparin, TE & Zinc

Datei Levelvi
29/08/2014 Patient Data Module (PDM) Medical Recall for Class I Hospital
Used with CARESCAPE Monitor Device Product
B850, B650, or B450 Correction
(Multiparameter Patient Monitor)
29/08/2014 V5Ms transesophageal Medical Recall for Class I Hospital
transducer (used for ultrasound Device Product
imaging) Correction
27/08/2014 CLAW and CLAW II Plates (An Medical Hazard Alert Class I Hospital
internal fixation device for the Device
stabilisation of fractured bones
and/or bone fragments)
27/08/2014 DePuy S-ROM Noiles Rotating Medical Recall Class II Hospital
Hinge Femur with Pin Device
27/08/2014 Spectra Optia Apheresis System Medical Recall for Class II Hospital
- Return Line Air Detector Device Product
(RLAD) Correction
26/08/2014 Omrix Pressure Regulator Medical Recall Class I Hospital
(Surgical air pipeline regulator) Device
Centaur XP Immunoassay Device Product
22/08/2014 CentraLink Data Management Medical Recall for Class II Hospital
System V14 (Analyser software Device Product
for in vitro diagnostic medical Correction
device (IVD))
22/08/2014 Precise Treatment Table ( A Medical Recall for Class I Hospital
patient treatment support and Device Product
positioning table for radiation Correction
therapy and simulation use.)
22/08/2014 Test Tube Heater - Power Medical Recall Class III Hospital
Supply Unit Device
22/08/2014 Vapotherm Disposable Patient Medical Recall Class II Hospital
Circuit System (Delivers high Device
flow humidified gases via a nasal
cannula or other patient
interface)
21/08/2014 Haemoglobin A1c (HbA1c) Flex Medical Recall for Class II Hospital
Reagent Cartridge (An in vitro Device Product
used with Dimension Vista
Systems)
21/08/2014 Luminos dRF and Luminos dRF Medical Recall for Class II Hospital
Max systems Device Product
Correction
21/08/2014 TOPPER Xtra Absorbent Medical Recall Class II Hospital
Dressing Pads, Sterile Device
20/08/2014 ADVIA Centaur & ADVIA Medical Recall for Class I Hospital
Centaur XP Immunoassay Device Product
System (An in vitro diagnostic Correction
medical device (IVD))
20/08/2014 Neoflow Flow Sensor and Medical Recall Class I Hospital
Neoflow Insert Device

Datei Levelvi
20/08/2014 Tegris OR Table Control Medical Recall for Class II Hospital
(Operating room device Device Product
management system) Correction
18/08/2014 Herculite Ultra Medical Recall Class III Retail
Device
18/08/2014 HS66 Turbo LTSF Steriliser Medical Recall for Class II Hospital
Device Product
Correction
18/08/2014 OXYGEN Sterile Protection Medical Recall Class II Hospital
Device
18/08/2014 Philips HeartStart FR3, software Medical Recall for Class I Retail
version 2.0 (Automated external Device Product
defibrillator (AED)) Correction
18/08/2014 St. Jude Medical Ellipse VR/DR Medical Hazard Alert Class I Hospital
Implantable Cardioverter Device
Defibrillators (ICDs)
18/08/2014 Vanguard 360 Femoral Boss Medical Recall Class II Hospital
Reamer Device
14/08/2014 HeartWare Ventricular Assist Medical Recall Class I Hospital
System batteries Device
14/08/2014 Monaco and Focal (radiation Medical Recall for Class I Hospital
treatment planning systems) Device Product
Correction
14/08/2014 VELCADE (bortezomib) 3.5 mg Medicine Recall Class II Hospital
powder for injection vial
11/08/2014 LIAISON Biotrin Parvovirus B19 Medical Recall for Class II Hospital
IgM Device Product
Correction
11/08/2014 Red Back Spider Antivenom Medicine Recall Class I Hospital
500U Injection Vial
8/08/2014 ADVIA Centaur CP – BNP Medical Recall for Class II Hospital
Device Product
Correction
8/08/2014 BD Epicenter v6.20A (used in Medical Recall for Class III Hospital
conjunction with Bruker MALDI Device Product
BioTyper) An in vitro diagnostic Correction
8/08/2014 Chemistry 1 Calibrator used on Medical Recall for Class II Hospital
Dimension Vista Systems Device Product
(Magnesium assay calibrator). Correction
device (IVD).
8/08/2014 Processor HDTV Visera Elite, Medical Recall for Class II Hospital
Processor HDTV Exera III, 3d Device Product
Visualization Unit, Light Source Correction
Xenon Visera Elite, Light Source
Xenon Exera III, High Flow Co2
Insufflator, Scopeguide Unit &
Video System Center
(components or parts of
endoscopes)
8/08/2014 STERIS 4085, 4085 SS and Medical Recall for Class II Hospital
4085 Feather Weight Leg Device Product
Section (FLWS) Surgical tables Correction

Datei Levelvi
8/08/2014 Symbia T Series and Symbia Medical Recall for Class I Hospital
Intevo Camera System Device Product
(SPECT/CT diagnostic imaging Correction
system)
8/08/2014 Transpac Monitoring Kits Medical Recall Class I Hospital
Device
7/08/2014 Bayer Elevit with Iodine Tablets Medicine Recall Class III Retail
6/08/2014 Shigella dysenteriae Polyvalent Medical Recall Class II Hospital
(1 – 10) Agglutinating Serum Device
(reagent intended for the
identification of Shigella
dysenteriae). An in vitro
5/08/2014 Ultrafilter U9000 (Used on Medical Recall for Class I Hospital
Gambro Haemodialysis Delivery Device Product
Systems.) Correction
1/08/2014 Amoxicillin + clavulanic acid 20 & Medical Recall Class II Hospital
10 ìg discs. An in vitro diagnostic Device
1/08/2014 E.CAM or Symbia E System: Medical Recall for Class II Hospital
Rear Casters of the Collimator Device Product
Cart Correction
31/07/2014 BD BBL Vancomycin Screen Medical Recall Class II Hospital
Agar Device
31/07/2014 Kodak DirectView DR 7500 Medical Recall for Class I Hospital
(Diagnostic x-ray system) Device Product
Correction
31/07/2014 Of Spiggle & Theis PTFE Medical Recall for Class II Hospital
Ventilation Tubes Device Product
Correction
31/07/2014 Philips Ultrasound QLAB Medical Recall for Class II Hospital
versions 10.0 and 10.1 Device Product
Correction
31/07/2014 T-PAL (Transforaminal Posterior Medical Recall for Class I Hospital
Atraumatic Lumbar Cage Device Product
System) Correction
30/07/2014 PRISMA, PRISMAFLEX, X- Medical Recall for Class II Hospital
MARS and ADSORBA sets Device Product
Correction
29/07/2014 Surgical Instruments with flexible Medical Recall for Class II Hospital
shafts Device Product
Correction
29/07/2014 Sysmex CS-2000i/CS-2100i/CS- Medical Recall for Class II Hospital
5100 Automated blood Device Product
coagulation analysers. An in vitro Correction
25/07/2014 Clinical Chemistry ICT Serum Medical Recall for Class I Hospital
25/07/2014 Discovery XR656 Wall Stand Medical Recall for Class II Hospital
System (X-ray system) Device Product
Correction

Datei Levelvi
25/07/2014 Expression IP5 Information Medical Recall for Class II Hospital
Portal (Multiparameter patient Device Product
monitor for use during MRI Correction
procedure)
25/07/2014 Prinivil (Lisinopril)10mg and Medicine Recall Class II Retail
20mg Tablets
24/07/2014 CHEMMART PHARMACY Medicine Recall Class III Retail
IBUPROFEN 200mg Soft Gel
capsule blister pack (Pack sizes:
20s, 40s, lOOs)
24/07/2014 Codman Certas Programmable Medical Hazard Alert Class I Hospital
Valves (Hydrocephalic valve) Device
24/07/2014 COSEAL Surgical Sealant 2ml Medical Recall Class II Hospital
and 4ml Device
24/07/2014 Panbio Q Fever IgM ELISA. An Medical Recall Class II Hospital
(IVD)
24/07/2014 VITROS Immunodiagnostic Medical Recall Class I Hospital
Products CA 19-9 Calibrators Device
and Reagent Packs
22/07/2014 Allura Xper R8.2.0 (Fluoroscopic Medical Recall for Class I Hospital
Correction
22/07/2014 Cooper Surgical TransWarmer Medical Recall Class II Hospital
Infant Transport Mattress Device
(Produces heat through chemical
reaction)
21/07/2014 Alegria Anti-Intrinsic Factor Medical Recall Class II Hospital
Assay Device
18/07/2014 AVS ARIA Implant Inserter Medical Recall Class I Hospital
Device
18/07/2014 Injectomat Agilia Range (Std, Medical Recall for Class II Hospital
MC & TIVA), Volumat Agilia Device Product
Range (Std & MC) Correction
18/07/2014 Philips Gel-E Donut and Medical Recall Class II Hospital
Squishon 2 (Gel filled Pillow) Device
18/07/2014 TXR-ME (Tri-Ex Extraction Medical Recall Class II Hospital
Balloon with Multiple Sizing) Device
16/07/2014 EmbryoScope Time-Lapse Medical Recall for Class II Hospital
Incubator Device Product
Correction
16/07/2014 Sonopet Console (Ultrasonic Medical Recall for Class II Hospital
Surgical Aspirator System) Device Product
Correction
15/07/2014 Minstrel Patient Transfer Lift with Medical Recall for Class I Retail
Scale Device Product
Correction
15/07/2014 National Workplace First Aid Kit Medical Recall Class II Retail
& Sports & Outdoors First Aid Kit Device
15/07/2014 Philips Ingenia 1.5T and 3.0T Medical Recall for Class I Retail
MR Systems Device Product
Correction

Datei Levelvi
14/07/2014 Brainlab Patient Data Manager Medical Recall for Class I Hospital
Device Product
Correction
14/07/2014 CARESCAPE respiratory Medical Recall for Class I Hospital
modules E-sCO, E-sCOV, E- Device Product
sCAiO, E-sCAiOV, E-sCAiOE, E- Correction
sCAiOVE & the Airway Gas
Option N-CAiO
14/07/2014 LIFEPAK 1000 Defibrillator Medical Recall for Class I Hospital
Device Product
Correction
11/07/2014 Artis Q and Artis Q zen systems Medical Recall for Class II Hospital
(Fluoroscopic X-ray systems) Device Product
Correction
Correction
11/07/2014 Pasteur Pipettes for use in IVF Medical Recall Class II Retail
Device
10/07/2014 5mL Reaction Vessels used with Medical Recall Class I Hospital
the m2000sp Instrument. An in Device
(IVD)
10/07/2014 ProcedurePak (surgical Medical Recall Class II Hospital
procedure packs) Device
10/07/2014 Specular Microscope SP-1P Medical Recall for Class II Hospital
(non-invasive photographic Device Product
microscope) Correction
9/07/2014 MobileDiagnost wDR (digital x- Medical Recall for Class II Hospital
ray system) Device Product
Correction
9/07/2014 VITROS 3600 Immunodiagnostic Medical Recall for Class II Hospital
Systems, VITROS 4600 Device Product
Chemistry Systems & VITROS Correction
5600 Integrated Systems
(Software Versions 3.0 & below)
8/07/2014 LED Single Bay Battery Charger, Medical Recall Class II Hospital
supplied with LED Headlight Device
System
8/07/2014 RECLAIM Distal Stem with Medical Recall for Class II Hospital
Taper Sleeve Protector (Press-fit Device Product
hip femur prosthesis) Correction
8/07/2014 TRIGEN INTERTAN Medical Recall Class II Hospital
Intramedullary Nail 13MM X Device
20CM 125D
7/07/2014 Bartels Herpes Simplex Virus Medical Recall for Class III Hospital
Fluorescent Monoclonal Device Product
Antibody Test. An in vitro Correction
7/07/2014 HOYA Corporation (PENTAX Medical Recall for Class II Hospital
Medical) – Gas/Water Feeding Device Product
Valve Correction

Datei Levelvi
7/07/2014 Large Clip Applier for use with Medical Recall for Class II Hospital
the da Vinci STM and da Vinci Device Product
SiTM Correction
7/07/2014 NexGen Complete Knee Solution Medical Hazard Alert Class II Hospital
MIS Total Knee Procedure Device
Stemmed Tibial Component,
Precoat
4/07/2014 3M ESPE Filtek Supreme XTE Medical Recall Class III Hospital
Flowable Restorative (Dental Device
material)
4/07/2014 Affinity Four Birthing Bed Medical Recall for Class II Hospital
Device Product
Correction
4/07/2014 Cordis EMPIRA NC RX PTCA Medical Recall for Class I Hospital
Dilatation Catheter Device Product
(“75RxxyyyN”) and Cordis Correction
EMPIRA RX PTCA Dilatation
Catheter (“85RxxyyyS”)
4/07/2014 Horizon Cardiology Hemo1 – Medical Recall for Class II Hospital
versions 12.2 HF4 and earlier Device Product
Correction
4/07/2014 InTouch Critical Care Bed Medical Recall for Class II Hospital
Device Product
Correction
4/07/2014 qube Compact Monitor Medical Recall for Class II Hospital
(Transportable mutiparameter Device Product
patient monitor) Correction
4/07/2014 Slide-in Plug Adaptor for Charger Medical Recall for Class II Hospital
used with Haag Streit UK Device Product
Perkins MkIII Tonometer Correction
4/07/2014 Thioglycollate Medium (bacteria Medical Recall Class II Hospital
culture media). An in vitro Device
3/07/2014 m24sp Instrument System Medical Recall for Class II Hospital
(sample extraction system). An Device Product
(IVD)
3/07/2014 Panthera-Puncher 9, An in vitro Medical Recall for Class I Hospital
Correction
2/07/2014 BD Vacutainer CPT Cell Medical Recall Class II Hospital
Preparation Tube. An in vitro Device
2/07/2014 C-Series High Energy Linear Medical Recall for Class I Hospital
Accelerator Device Product
Correction
2/07/2014 RAPIDQC Complete Quality Medical Recall for Class II Hospital
Control Material (QC reagent for Device Product
use with blood gas instruments). Correction
device (IVD).
1/07/2014 Lancet, Low Flow and Micro Medical Recall Class II Retail
Flow Device

Datei Levelvi
30/06/2014 Damon TMA - Low Friction Medical Recall for Class III Retail
Archwire (orthodontic wire) Device Product
Correction
30/06/2014 Horizon Medical Imaging Medical Recall for Class II Hospital
Products Versions 4.6.1 up to Device Product
and including 11.9 and Correction
McKesson Radiology 12.0
(Radiology picture archiving and
30/06/2014 MSA Hip System Medical Hazard Alert Class II Hospital
Device
27/06/2014 BrightView XCT and BrightView Medical Recall for Class II Hospital
X- upgraded with the XCT Flat Device Product
Panel Detector (Gamma camera) Correction
27/06/2014 Crepe Bandage 5cm x 1.5m Medical Recall Class II Hospital
Device
26/06/2014 Micro-Injection Pipettes for IVF Medical Recall Class III Hospital
procedures Device
25/06/2014 ACL Top Family of instruments Medical Recall for Class I Hospital
(haemostasis testing systems). Device Product
device (IVD).
25/06/2014 DX-D 100 Digital Radiography X- Medical Recall for Class II Hospital
Ray System Device Product
Correction
25/06/2014 IntelliVue MX40 Medical Recall for Class I Hospital
Device Product
Correction
24/06/2014 BOC Medical E.P. Grade Medicine Recall Class III Hospital
Oxygen Compressed supplied in
Size D Cylinders
24/06/2014 CARESCAPE Monitor B850, Medical Recall for Class II Hospital
B650 or B450 Monitors with V2 Device Product
software versions Correction
(Multiparameter patient monitors)
24/06/2014 Skin Graft Knife Blades for use Medical Recall Class II Hospital
with Thackray Watson Cobbett Device
and Braithwaite Skin Graft Knife
(Pack of 10 blades)
23/06/2014 500 Series Vertical Rails Medical Recall Class II Retail
Device
23/06/2014 ACUSON S Family Ultrasound Medical Recall for Class I Hospital
Systems with software versions Device Product
VC25D, VC30A, VC30B Correction
23/06/2014 Cardioxyl Sutures Medical Recall Class II Hospital
Device
23/06/2014 INTELEPACS Version 3.8.1 and Medical Recall for Class II Hospital
up (Radiology picture archiving Device Product
and communication system) Correction
23/06/2014 Logical Ceramic Liner Medical Recall Class II Sponsor
Device

Datei Levelvi
18/06/2014 BD FACSCanto 10 colour Medical Recall for Class III Hospital
configuration (Cytometer). An in Device Product
(IVD)
18/06/2014 HeartSineTechnologies Pad- Medical Recall Class III Wholesale
Pak/ Pedi-Pak (contains non- Device
rechargeable battery and
defibrillation electrodes for use
with the HeartSine Samaritan
PAD 350P and 500P
Defibrillators)
18/06/2014 Multi Lumen and Pressure Medical Recall for Class II Hospital
Injectable Central Venous Device Product
Catheters Correction
18/06/2014 Muro 128 5% Ointment (Sodium Medicine Recall Class II Hospital
Chloride Hypertonicity
Ophthalmic Ointment, 5%) Tube
3.5g
with 9.4 inch graphical user Device Product
interface (GUI) assembly Correction
18/06/2014 Thermablate Endometrial Medical Recall for Class II Hospital
Ablation System (EAS) Device Product
Correction
17/06/2014 Anspach Attachments and Medical Recall for Class II Hospital
Handpieces (reusable surgical Device Product
devices) Correction
17/06/2014 Axiom Artis and Artis Zee Medical Recall for Class II Hospital
Systems with hand switch Device Product
(Fluoroscopic angiographic X-ray Correction
system)
17/06/2014 Cortex Screw Ø 1.5 mm, self- Medical Recall Class II Hospital
tapping, length 8 mm (non- Device
biodegradeable orthopaedic
bone screw)
17/06/2014 Pulmonary Valve Allograft Biological Hazard Alert Class I Hospital
13/06/2014 Medtronic Duet External Medical Recall Class I Hospital
Drainage and Monitoring System Device
(Cerebrospinal fluid drainage
system)
13/06/2014 SOLIRIS eculizumab (rmc) Medicine Recall Class II Hospital
Concentrated Solution for
Infusion 300mg/30mL
12/06/2014 Proteus XR/a X-ray imaging Medical Recall for Class II Hospital
systems and Revolution XR/d X- Device Product
ray imaging systems Correction
11/06/2014 Ingenia MR FlexTrak Trolley Medical Recall for Class II Hospital
Device Product
Correction
11/06/2014 Medtronic Navigation Planning Medical Recall for Class III Hospital
Station Device Product
Correction
11/06/2014 RIA Coat-A-Count Medical Recall for Class II Hospital
Androstenedione Device Product
Correction

Datei Levelvi
6/06/2014 Alere Triage BNP Calibrator for Medical Recall Class II Hospital
Beckman Coulter Device
6/06/2014 Guide Wire diameter 3.2mm, Medical Recall Class II Hospital
length 400mm (Fixation nail Device
guidewire)
6/06/2014 Single-width Airway Module E- Medical Recall for Class I Hospital
miniC and Extension Modules N- Device Product
FC & N-FCREC Correction
5/06/2014 ADVIA Centaur, ADVIA Centaur Medical Recall for Class I Hospital
XP and ADVIA Centaur CP - Device Product
Troponin Ultra ReadyPack. An in Correction
(IVD).
5/06/2014 Digital Linear Accelerators of Medical Recall for Class II Hospital
type ARTISTE, ONCOR and Device Product
PRIMUS with Automatic Correction
Sequenced Treatment Delivery
Option
5/06/2014 Fludeoxyglucose F18, sterile Medicine Recall Class II Hospital
injectable solution, multidose vial
Device Product
Correction
4/06/2014 MENTOR Gel Sizers (Sizer for Medical Recall Class II Hospital
mammary prosthesis) Device
3/06/2014 AGA Medical Amplatzer Septal Medical Recall Class II Hospital
Occluder Device
3/06/2014 DCP 2.0, 7 holes, length 37 mm, Medical Recall Class III Hospital
Stainless Steel, Sterile ( Non- Device
biodegradable orthopaedic
fixation plate)
3/06/2014 HexaPOD evo RT Systems Medical Recall for Class I Hospital
running iGUIDE 2.0.0 - 2.0.2 Device Product
(used for accurate patient Correction
positioning within a radiation
therapy treatment environment)
3/06/2014 Horizon Medical Imaging Medical Recall for Class II Hospital
products versions 4.5 up to and Device Product
including 11.9 and McKesson Correction
Radiology 12.0 (Radiology
3/06/2014 RAPIDPoint 500 Measurement Medical Recall for Class III Hospital
Cartridges. An in vitro diagnostic Device Product
3/06/2014 Tytin Regular Set (Dental Medical Recall Class II Retail
amalgam) Device
3/06/2014 VTI Bayonet 20 MHz Doppler Medical Recall Class I Hospital
Probe (used for the Device
intraoperative and
transcutaneous critical
evaluation of blood flow)

Datei Levelvi
30/05/2014 5mm Round Fluted Bur Medical Recall Class II Hospital
Aggressive, Round Fluted Soft Device
Touch 3.0mm, Round Fluted Bur
6.0mm, 3mm Round Fluted Bur
Aggressive, Neuro Drill 3.0mm,
6mm Round Fluted Bur
Aggressive, Round Fluted Bur
1.0mm and 5.0mm Egg Bur
(Orthopaedic bur used for soft
tissue debridement and bone
abrasion and removal)
30/05/2014 Accu-Chek Spirit Combo insulin Medical Recall Class II Consumer
pump Device
30/05/2014 BBL Crystal Medical Recall for Class II Hospital
Enteric/Nonfermenter ID Kit. An Device Product
(IVD).
30/05/2014 Orbital Rim Plate 1.3, curved, 9 Medical Recall for Class III Hospital
holes, Pure Titanium Device Product
(Craniofacial fixation plate) Correction
29/05/2014 ACUSON S2000 and ACUSON Medical Recall for Class II Hospital
S3000 Ultrasound Systems Device Product
(software version VC25) or with Correction
HELX Evolution (software
version VC30A)
29/05/2014 CARESCAPE Monitor B650 Medical Recall for Class I Hospital
Device Product
Correction
29/05/2014 HAMILTON G5 / S1 ICU Medical Recall for Class I Hospital
ventilators Device Product
Correction
29/05/2014 Hamilton Galileo Ventilator when Medical Recall for Class II Hospital
used with Flexport Device Product
Communication Interface Correction
Protocol version 1.2
28/05/2014 Accu-Chek Mobile Blood Medical Recall for Class I Consumer
Glucose Meter Device Product
Correction
28/05/2014 Hamilton Medical G5 / S1 Medical Recall for Class I Hospital
Ventilator, software versions Device Product
between V2.00 and V2.31 Correction
27/05/2014 Disposable Ventstar 180cm Medical Recall Class I Hospital
Circuit (used in connection with Device
the Drager Oxylog 2000
Transport Ventilator)
26/05/2014 ThermoCool SF NAV Catheter Medical Recall for Class I Hospital
Family Device Product
Correction
23/05/2014 Axium Neurostimulator Leads Medical Recall for Class II Hospital
(MN20450-50AU, MN20450- Device Product
90AU) Correction
23/05/2014 HYGROTON Chlorthalidone Medicine Recall Class III Wholesale
25mg Tablets
23/05/2014 SmartMonitor 2 Professional Medical Recall for Class II Hospital
Series Device Product
Correction

Datei Levelvi
23/05/2014 Tecnis CL Foldable Silicone IOL Medical Recall Class II Hospital
with OptiEdge Design Device
22/05/2014 Baxter Peritoneal Dialysis Medical Recall for Class I Hospital
Transfer Sets, Titanium Device Product
Adapters, Disconnect Caps and Correction
Clamshell
22/05/2014 Ingenia, Intera and Achieva MR Medical Recall for Class I Hospital
Systems on software version Device Product
R5.1.1 and R5.1.2 Correction
22/05/2014 Polyurethane Nasogastric Medical Recall Class II Hospital
Feeding Tube Device
22/05/2014 syngo Lab Data Manager. Medical Recall for Class II Hospital
Middle-ware for use with in vitro Device Product
diagnostic medical devices Correction
(IVD).
22/05/2014 Synthes Trauma External Medical Recall for Class II Hospital
Fixation System (Small, Medium, Device Product
Distraction Osteogenesis (DO) Correction
Ring and Large)
21/05/2014 Ultrasonic Transducer Kits used Medical Recall for Class II Hospital
with the Access Family of Device Product
Immunoassay Systems. An in Correction
(IVD)
20/05/2014 MGuard Prime Coronary Stent Medical Recall Class I Hospital
System Embolic Protective Stent Device
(EPS)
20/05/2014 Mobile Shower and Toilet Medical Recall for Class II Consumer
Commode Aquatec Ocean VIP Device Product
Correction
20/05/2014 MobileDiagnost wDR (Mobile x- Medical Recall for Class II Hospital
ray imaging system) Device Product
Correction
20/05/2014 MOSAIQ Versions 1.40 through Medical Recall for Class I Hospital
2.50, inclusive (Oncology Device Product
information system used to Correction
manage workflows for treatment
planning and delivery)
20/05/2014 Nifehexal (Nifedipine) 20mg Medicine Recall Class III Retail
Tablets 60 Blister
20/05/2014 Tenor without scale (Mobile Medical Recall for Class I Hospital
patient transfer lift) Device Product
Correction
20/05/2014 Wireless Footswitch used in Medical Recall for Class II Hospital
conjunction with AXIOM Artis, Device Product
Artis Zee and Artis Q Systems Correction
16/05/2014 Ysio Systems (X-ray system) Medical Recall for Class II Hospital
Device Product
Correction
15/05/2014 Multiple Krill Oil Capsules Medicine Recall Class III Retail
Sponsored by Nature's Care

Datei Levelvi
15/05/2014 Single-width Airway Module E- Medical Recall for Class I Hospital
miniC and Extension Modules N- Device Product
FC & N-FCREC (used with Correction
CARESCAPE Monitors B850,
B650 and B450, S/5 modular
monitors, Engstrom Carestation,
Patient Monitor B30, S/5M and
FML monitors)
13/05/2014 ACUSON SC2000 Ultrasound Medical Recall for Class II Hospital
Systems with Software Version Device Product
3.5 (VA35) Correction
13/05/2014 G7 Positioning Guide Rod & G7 Medical Recall Class II Hospital
Positioning Guide Post Device
13/05/2014 Hill-Rom MC700 General Ward Medical Recall for Class II Retail
Bed Device Product
Correction
13/05/2014 MAGNETOM Aera (Full Body Medical Recall for Class II Hospital
MRI System) Device Product
Correction
13/05/2014 MiniCap Extended Life PD Medical Recall Class I Consumer
Transfer Set with Twist Clamp Device
(Peritoneal dialysis tubing set)
12/05/2014 Intuitive Surgical Inc. – 5mm Medical Recall for Class II Hospital
Curved Cannula for Single-Site Device Product
Instruments for da Vinci Surgical Correction
Systems
12/05/2014 MIBG I-131 Therapy Injection Medicine Recall Class I Hospital
(metaidobenzylguanidine
labelled as iodine- 131)
9/05/2014 ConMed MacroLyte Premie Medical Recall Class I Hospital
Dispersive Electrode Device
9/05/2014 PentaRay Nav Catheter (used Medical Recall Class I Hospital
for multiple electrode Device
cardiac structures in the heart)
9/05/2014 Sidhil Inspiration Cot Medical Recall for Class I Hospital
Device Product
Correction
9/05/2014 Tension Band Pins (Internal Medical Recall Class III Hospital
fixation pins) Device
8/05/2014 Flexi-Seal CONTROL Faecal Medical Recall Class I Hospital
Management System Device
8/05/2014 Model 5348 Single-Chamber Medical Recall for Class I Hospital
External Pulse Generator Device Product
Correction
8/05/2014 Receptal System Liners and Medical Recall for Class I Hospital
Canisters Device Product
Correction
7/05/2014 GLUMA Desensitizer Power Gel Medical Recall Class II Retail
( Polymer based dental bonding Device
agent)
7/05/2014 PATH Thread Cup Adaptor Medical Recall Class II Hospital
Device

Datei Levelvi
7/05/2014 Synapse Cardiovascular (CV) Medical Recall for Class II Hospital
Client application, version 4.0.8 Device Product
(Picture archiving and Correction
7/05/2014 VITROS ALT, ALKP, AST, CHE, Medical Recall for Class II Hospital
CK, GGT and LDH results Device Product
generated on VITROS 4600 Correction
Chemistry System, VITROS
5600 Integrated System and
VITROS 5,1 FS Chemistry
System
6/05/2014 Lithium Ion Batteries, M4605A Medical Recall for Class II Hospital
and M4607A for use with Device Product
IntelliVue Patient Monitors Correction
5/05/2014 Alere INRatio2 PT/INR Heparin Medical Recall for Class I Hospital
Insensitive Test Strips Device Product
Correction
5/05/2014 FOLFusor SV 0.5mL/hr used for Medicine Recall Class II Hospital
infusing patient specific
compounded Fluorouracil
(Fluorouracil compounded for
treatment of cancer)
5/05/2014 HeartWare Ventricular Assist Medical Recall for Class I Hospital
System batteries Device Product
Correction
5/05/2014 Medtronic Navigation Sterile Medical Recall Class II Hospital
Devices (used in a variety of Device
imaged guided, navigated
surgical procedures)
Testing Penicillin (P1) Discs (an Device
(IVD))
29/04/2014 12 Instrument Sterilisation Tray Medical Recall for Class II Hospital
(used for the Conquest Manual Device Product
Instrument line) Correction
Systems with software version Device Product
3.5 (VA35) Correction
29/04/2014 Compact Airway Modules E-CO, Medical Recall for Class I Hospital
E-COV, E-COVX, E-CAiO, E- Device Product
CAiOV & E-CAiOVX (used with Correction
CARESCAPE Monitors B850
and B650, Avance and Aisys
Anesthesia Carestations,
Engstrom Respiratory
Carestation, or S/5 Anesthesia
and Critical Care Monitors)
Systems (enGen) with Device Product
TCAutomation Software v2.6, Correction
v3.2 and v3.5 Configured with
Bypass Modules for ADVIA
Centaur, Abbott Architect,
VITROS and/or Tosoh AIA
Systems (an in vitro diagnostic

Datei Levelvi
29/04/2014 RaySearch RayStation, version Medical Recall for Class I Hospital
4.0.3 (Radiation therapy Device Product
treatment planning system) Correction
28/04/2014 Percutaneous Sheath Introducer Medical Recall Class I Hospital
Kits Device
Correction
28/04/2014 SynFix-LR Surgical Implant Medical Recall for Class II Hospital
Holder Device Product
Correction
24/04/2014 Bond Ready-To-Use Primary Medical Recall Class I Hospital
Antibody Thyroglobulin (1D4) Device
(An in vitro Diagnostic Medical
Device (IVD)
24/04/2014 Brilliance CT 16, 64, Big Bore Medical Recall for Class I Hospital
iCT, Ingenuity CT, Ingenuity Device Product
Core, Ingenuity Core128, Correction
Ingenuity Flex
24/04/2014 Brilliance CT series (6, 10, 16, Medical Recall for Class I Hospital
16 Power, 40, 64, Big Bore, iCT, Device Product
iCT SP), Ingenuity CT, Ingenuity Correction
Ingenuity Flex, MX8000 Dual v.
EXP
24/04/2014 Corneo-scleral Disc Biological Hazard Alert Class II Hospital
(Normothermic)
24/04/2014 Craniomaxillofacial (CMF) Medical Hazard Alert Class I Hospital
Distraction System (modular Device
family of internal distraction
devices to lengthen the
mandibular body and ramus)
24/04/2014 Discovery MR450w, Discovery Medical Recall for Class I Hospital
MR750, Optima MR450w, Device Product
Optima MR450w equipped with Correction
the GEM option, Discovery
MR750w and Discovery
MR750w equipped with the GEM
option products (Full body
magnetic resonance imaging
(MRI) systems)
24/04/2014 FUJIFILM FDR-1000AWS / Medical Recall for Class II Hospital
FDR-2000AWS / FDR-3000AWS Device Product
V5.1.0001-0007 with Biopsy unit Correction
(a component of FUJIFILM
Digital Mammography System)
23/04/2014 HexaPOD evo RT Couchtop (X- Medical Recall for Class I Hospital
ray powered radiation therapy Device Product
table) Correction
23/04/2014 Otto Bock A200 Power Medical Recall for Class II Consumer
Wheelchair, SKIPPI and SKIPPI Device Product
PLUS Power Wheelchairs Correction
23/04/2014 Xyntha (moroctocog alfa) 500IU Medicine Recall Class II Consumer
Dual-Chamber Syringe

Datei Levelvi
17/04/2014 550 TxT Treatment Table used Medical Recall for Class I Hospital
with PRIMUS, ONCOR and Device Product
ARTISTE Digital Linear Correction
Accelerators (LINAC)
17/04/2014 Accu-Chek Mobile Blood Medical Recall for Class II Consumer
Glucose Monitoring System Device Product
Correction
17/04/2014 ADVIA Centaur, ADVIA Centaur Medical Recall for Class II Hospital
XP and ADVIA Centaur CP Device Product
Correction
17/04/2014 AQURE Data Management Medical Recall for Class II Hospital
Correction
17/04/2014 Colied-Tube INFUSOR System Medical Recall for Class II Hospital
Device Product
Correction
17/04/2014 FOLFusor SV 0.5 ml/hr Medical Recall for Class II Hospital
Device Product
Correction
17/04/2014 IMPAX RIS 5.8 and higher Medical Recall for Class II Hospital
(Picture archiving and Device Product
communication system software) Correction
17/04/2014 Luminos dRF (Fluoroscopic Medical Recall for Class I Hospital
diagnostic x-ray systems) Device Product
Correction
17/04/2014 MDC PACS Release R2.x and Medical Recall for Class I Hospital
IntelliSpace PACS DCX r3.x Device Product
(picture archiving and Correction
17/04/2014 Mueller Hinton-HTM (culture Medical Recall Class II Hospital
media). An in vitro diagnostic Device
17/04/2014 SOMATOM Emotion 6 / 16 Slice Medical Recall for Class I Hospital
Configuration and SOMATOM Device Product
Spirit/Spirit Power Systems (Full- Correction
body computed tomography (CT)
diagnostic x-ray system)
17/04/2014 syngo Dynamics v9.5 with Medical Recall for Class II Hospital
Sensis-syngo Dynamics Device Product
Integration (Radiology picture Correction
archiving and communication
system)
16/04/2014 Cochlear Baha Soft Tissue Medical Recall Class II Hospital
Gauge (included in the Cochlear Device
Baha Attract surgical tool kit)
16/04/2014 Panda iRes Warmers integrated Medical Recall for Class I Hospital
with Nellcor SpO2 Device Product
Correction
15/04/2014 Centricity PACS RA1000 Medical Recall for Class II Hospital
Workstation versions 3.2 and Device Product
higher (Picture archiving and Correction
14/04/2014 ExacTrac 5.5.5 (Image guided Medical Recall for Class I Hospital
radiation therapy patient Device Product
positioning system) Correction

Datei Levelvi
14/04/2014 Infant Nasal CPAP Prongs and Medical Recall Class I Hospital
Bubble CPAP Starter Kits Device
11/04/2014 DigitalDiagnost (Digital X-ray Medical Recall for Class II Hospital
System) Device Product
Correction
11/04/2014 Extension Tubing in Refill Kits for Medical Recall Class II Hospital
use with Synchromed pumps Device
11/04/2014 MEDRAD Continuum Infusion Medical Recall Class I Hospital
Pump Device
10/04/2014 Bayer CANESTEN clotrimazole Medicine Recall Class II Consumer
thrush treatment 6 day cream
35g
10/04/2014 EverCross .035" OTW PTA Medical Recall Class II Hospital
Catheter (Balloon dilatation Device
angioplasty catheter)
10/04/2014 LenSx Laser System (used for Medical Recall for Class II Hospital
femtosecond cataract surgery) Device Product
Correction
9/04/2014 Edwards Lifesciences Fem-Flex Medical Recall Class I Hospital
II Cannulae Device
9/04/2014 Lipase Reagent (diagnostic good Medical Recall for Class II Hospital
for the quantitation of lipase in Device Product
human serum or plasma) Correction
8/04/2014 ACUSON X700 Ultrasound Medical Recall for Class II Hospital
System with software versions Device Product
1.0.00, 1.0.01, 1.0.02, 1.1.00 or Correction
1.1.02
8/04/2014 Cavafix (used for the Medical Recall Class I Hospital
catheterisation of vena cava) Device
8/04/2014 Dynabeads HLA (Human Medical Recall Class II Hospital
Leucocyte Antigen) Class II (an Device
in vitro diagnostic medical
device)
8/04/2014 Potassium 10mmol in 0.225% Medical Recall Class I Hospital
Sodium Chloride and 10% Device
Glucose (500ml)
Systems configured with Data Device Product
Innovation, LLC Instrument Correction
Manager (IM) v8.06
7/04/2014 ICS G2 Clinical Access (used for Medical Recall Class III Hospital
acquiring 24-72 hours of Device
standard patient waveforms for
analysis)
7/04/2014 Monitor AC2000 Spring Arm Medical Recall Class II Hospital
Device
7/04/2014 Philips Ingenuity Core128 with Medical Recall for Class II Hospital
Software Version 3.5.5 (whole Device Product
body Computed Tomograph (CT) Correction
x-ray system)

Datei Levelvi
Specialty Diluent and VITROS Device Product
Chemistry Products FS Diluent Correction
Pack 3
4/04/2014 FELDENE (piroxicam) 10mg Medicine Recall Class III Retail
Capsules Blister packs of 50s
4/04/2014 Kenex suspension arm with Medical Recall for Class I Hospital
radiation shield and/or surgical Device Product
lamp Correction
4/04/2014 Pipeline Embolization Device Medical Recall Class I Hospital
and Alligator Retrieval Device Device
4/04/2014 Vivid E9 Ultrasound Systems, Medical Recall for Class II Hospital
software versions 113.0.1 to Device Product
113.0.5 when used with probes Correction
C1-5-D, C2-9-D, IC-5-9-D and
M5Sc-D
3/04/2014 Discovery MR450, Discovery Medical Recall for Class I Hospital
MR750, Optima MR450w, Device Product
Optima MR 450w GEM, Correction
Discovery MR750w, and
Discovery MR750w GEM
products (Full body magnetic
resonance imaging systems)
3/04/2014 Fraxel Dual 1550/1927 Laser Medical Recall for Class II Retail
Correction
2/04/2014 OEC 9900 Workstation Monitor Medical Recall for Class II Hospital
Spring Arm Screws Device Product
Correction
2/04/2014 Technetium-99m Oxidronate Medicine Recall Class II Hospital
HDP (Radioactive Dose
prepared as a solution in a
syringe for diagnostic imaging)
1/04/2014 ADAC Vertex Classic, Vertex Medical Recall for Class I Hospital
Plus, Vertex V60 and Solus Device Product
Systems Correction
1/04/2014 ARTIS Zeego (Fluoroscopic Medical Recall for Class II Hospital
angiographic x-ray system) Device Product
Correction
1/04/2014 Mindray’s V Series Monitoring Medical Recall for Class II Hospital
Correction
31/03/2014 Alere Triage BNP Test for Medical Recall for Class II Hospital
Beckman Coulter (intended to Device Product
measure B-type Natriuretic Correction
Peptide levels)
31/03/2014 Colleague Volumetric Infusion Medical Recall for Class II Hospital
Correction
28/03/2014 ADVIA Centaur Folate Assay Medical Recall Class III Hospital
Device
28/03/2014 LOVher Herbal Viagra Medicine Recall Class II Consumer

Datei Levelvi
27/03/2014 Datascope System 98/98XT, Medical Recall for Class I Hospital
CS100/CS100i and CS300 Intra- Device Product
Aortic Balloon Pumps (IABP) Correction
27/03/2014 Guide Wire Ø 3.2 mm, length Medical Recall for Class II Hospital
400 mm (used for the Device Product
implantation of intramedullary Correction
nails)
26/03/2014 DePuy S-ROM Noiles Rotating Medical Recall for Class II Hospital
Hinge Femur with Pin Device Product
(compatible with the MBT Correction
revision tibial tray)
26/03/2014 IntelliSpace Portal with Medical Recall for Class I Hospital
AutoSPECT Pro reconstruction Device Product
application (image viewing Correction
system for diagnostic imaging, x-
ray and computed tomography)
26/03/2014 On-Board Imager (OBI) (used Medical Recall for Class I Hospital
with linear accelerators for Device Product
verification of correct patient Correction
position in relation to isocenter
and verification of treatment
fields)
25/03/2014 Philips EPIQ 5 Ultrasound Medical Recall for Class II Hospital
Correction
25/03/2014 Philips EPIQ 7 Ultrasound Medical Recall for Class II Hospital
Correction
25/03/2014 Shape Arm Kit Left and Shape Medical Recall for Class I Hospital
Arm Kit Right Device Product
(Mounting/positioning system for Correction
flat panel monitors)
24/03/2014 Cup Removal Instruments Medical Recall for Class II Wholesale
(Reusable surgical instrument Device Product
used to remove an acetabular Correction
cup with minimal loss of bone)
24/03/2014 Threaded Reduction Tool, Medical Recall Class II Hospital
2.4mm diameter, self-drilling, Device
78mm length, with Hexagonal
coupling
20/03/2014 Expression Information Portal - Medical Recall for Class II Hospital
IP5 (secondary display control Device Product
unit for Expression MRI patient Correction
monitoring system)
20/03/2014 H LED and PowerLED Ambient Medical Recall for Class II Hospital
Light Modules (Surgical light) Device Product
Correction
20/03/2014 Stainless Steel Scissor, Medical Recall Class III Hospital
Universal Shear, Blue Handle Device
20/03/2014 Zoll X Series Defibrillators with Medical Recall for Class I Hospital
system software version Device Product
02.10.02.00 or higher Correction

Datei Levelvi
18/03/2014 Dimension Vista Cyclosporine Medical Recall for Class I Hospital
(CSA) Flex Reagent Cartridge Device Product
and Dimension Vista Correction
Cyclosporine (CSAE) Flex
Reagent Cartridge
18/03/2014 Endo-Scrub2 Sheaths and Medical Recall for Class III Hospital
Tubing Set Device Product
Correction
18/03/2014 HOTLINE Fluid Warming Sets Medical Recall Class II Hospital
Device
18/03/2014 Latex Test Lungs and Latex Medical Recall for Class I Hospital
Rebreathing Bags Device Product
Correction
17/03/2014 Natural-Knee II System with Medical Hazard Alert Class II Hospital
Metal-Backed Patella Device
17/03/2014 Philips HeartStart Home and Medical Recall Class I Hospital
OnSite (HS1) Automated Device
External Defibrillators
17/03/2014 Symbia T and Symbia T2 Medical Recall for Class II Hospital
Camera System (CT imaging Device Product
system) Correction
17/03/2014 Teleflex Medical CAPIO Sutures Medical Recall Class II Hospital
Device
17/03/2014 Unomedical Feeding Tubes Medical Recall for Class II Hospital
Device Product
Correction
14/03/2014 Sysmex CS-2100i and CS-5100 Medical Recall for Class I Hospital
Automated blood coagulation Device Product
analysers Correction
13/03/2014 CUSA Excel+ Sterile Torque Medical Recall for Class II Hospital
Disposable Wrench (23kHz) Device Product
Correction
13/03/2014 FB Reagent, ZYM B Reagent, Medical Recall for Class II Hospital
API Listeria and API NH Device Product
Correction
13/03/2014 HomeChoice PRO Automated Medical Recall for Class I Consumer
Peritoneal Dialysis (PD) System Device Product
Correction
12/03/2014 Brain and Spinal Cord Medical Hazard Alert Class I Hospital
Stimulators Device
12/03/2014 INTELEVIEWER Versions 3.8.1 Medical Recall for Class II Hospital
P355 and up (radiology picture Device Product
archiving and communication Correction
system)
12/03/2014 Liaison Biotrin Control Medical Recall for Class II Hospital
Parvovirus B19 IgM Device Product
Correction
12/03/2014 Spinal Cord Stimulation Medical Hazard Alert Class I Hospital
Neurostimulators, Spinal Cord Device
Stimulation Leads, Kits and
Patient Programmers
12/03/2014 UltraClean Antarctic Krill 1500mg Medicine Recall Class II Retail

Datei Levelvi
11/03/2014 Pinnacle3 Radiation Treatment Medical Recall for Class I Hospital
Planning System, software Device Product
version 9.0 Correction
7/03/2014 syngo Dynamics software Medical Recall for Class I Hospital
version v9.5 using Sensis Device Product
Integration (Radiology picture Correction
archiving and communication
system)
6/03/2014 Cereform Silicone Gel filled Medical Recall Class II Hospital
Breast Implants and Device
Corresponding Sizers
5/03/2014 Thymoglobuline (rabbit anti- Medicine Recall Class II Hospital
human thymocyte
immunoglobulin) 25mg powder
for infusion
4/03/2014 D-10 Haemoglobin Testing Medical Recall for Class II Hospital
4/03/2014 ExacTrac 6.0.3 Patient Medical Recall for Class I Hospital
Positioning System (Image Device Product
guided radiation treatment Correction
therapy patient positioning
system)
4/03/2014 Head Positioning Devices Medical Recall Class II Hospital
Device
4/03/2014 Philips HeartStart FR3 Medical Recall for Class I Hospital
Device Product
Correction
4/03/2014 STERRAD 100S Cassettes Medical Recall Class III Hospital
Device
3/03/2014 INNOVA 2121IQ (Cardiovascular Medical Recall for Class I Hospital
X-ray imaging system) Device Product
Correction
Correction
3/03/2014 Samaritan PAD 500P (Public Medical Recall for Class I Retail
Access Defibrillator) Device Product
Correction
3/03/2014 VerifyNow IIb/IIIa 25 Test and Medical Recall Class II Hospital
VerifyNow IIb/IIIa 10 Test (An in Device
vitro Diagnostic Medical Device
(IVD))
3/03/2014 XiO Software build versions 4.1 Medical Recall for Class I Hospital
and higher (Radiation therapy Device Product
treatment planning system) Correction
27/02/2014 Alaris SmartSite Needlefree Medical Recall Class II Hospital
Connector Device
Correction
26/02/2014 Edi Catheter (nasogastric Medical Recall for Class II Hospital
feeding tube) Device Product
Correction

Datei Levelvi
26/02/2014 Indiko and Indiko Plus Chemistry Medical Recall for Class I Hospital
Analysers Device Product
Correction
26/02/2014 Tri-Flex II Bed Medical Recall for Class II Hospital
Device Product
Correction
25/02/2014 Philips HeartStart XL, Medical Recall for Class I Hospital
Correction
25/02/2014 Wireless Link for HeartStart MRx Medical Recall for Class III Hospital
Correction
24/02/2014 HINTEGRA Standard and Medical Recall for Class II Hospital
Revision tibial and talar Device Product
components (Total Ankle Correction
Prosthesis)
24/02/2014 Lithium Ion batteries used with Medical Recall for Class I Hospital
Philips HeartStart MRx Device Product
Monitor/Defibrillator Correction
Monitor/Defibrillator with Q-CPR Device Product
Correction
24/02/2014 Proceed Surgical Mesh Medical Recall Class II Hospital
Device
24/02/2014 RayStation 3.5 and 4.0 Medical Recall for Class I Hospital
24/02/2014 SPAPLuS Analysers. An in vitro Medical Recall for Class III Hospital
Correction
21/02/2014 Aquarius Regional Citrate Medical Recall for Class I Hospital
Anticoagulation (RCA) Device Product
Haemofiltration Device Correction
Correction
Correction
20/02/2014 ADVIA Centaur XP Medical Recall for Class II Hospital
Immunoassay System (an in Device Product
(IVD))
20/02/2014 Ding Chuan Wan (Gingko Nut & Medicine Recall Class III Retail
Apricot Seed Formula), Xiao
Qing Long Tang (Minor Blue
Dragon Combination) & Fang
Feng Tong Shen Wan (Siler &
Platycodon Formula)
20/02/2014 FreeStyle Papillon Mini Blood Medical Recall Class I Consumer
Glucose Monitoring System Device
20/02/2014 OPMI Pentero surgical Medical Recall for Class II Hospital
microscope system (PC 2.1) Device Product
Correction

Datei Levelvi
19/02/2014 Neuromuscular Transmission Medical Recall for Class II Hospital
Module used with Carescape Device Product
and Datex-Ohmeda S/5 Correction
Anaesthesia monitors
19/02/2014 VDR Proximal Targeting Guide Medical Recall for Class II Hospital
in Acu-Loc 2 Loan sets Device Product
Correction
18/02/2014 Oxylog Transport Ventilator Medical Recall for Class I Hospital
Device Product
Correction
18/02/2014 PS500 External Power Supply Medical Recall for Class I Hospital
Unit used with Dräger V Series Device Product
Ventilators Correction
17/02/2014 GemStar 7 Therapy Pump and Medical Recall for Class II Hospital
GemStar Pain Management Device Product
Pump (Phase 3 pumps) Correction
17/02/2014 Peristeen Anal Irrigation System Medical Recall for Class II Consumer
Device Product
Correction
14/02/2014 ACE Control. An in vitro Medical Recall for Class II Hospital
Correction
14/02/2014 ARCHITECT Intact Parathyroid Medical Recall Class II Hospital
(PTH) Assay. An in vitro Device
14/02/2014 Communication Engine in Plum Medical Recall for Class III Hospital
A+ and A+3 Infusion Pump Device Product
Correction
13/02/2014 Calibrator BRAHMS Free beta- Medical Recall Class II Hospital
hCG KRYPTOR CAL. An in vitro Device
13/02/2014 DePuy CMW 2 Gentamicin Bone Medical Recall for Class III Hospital
Cement 20 g Device Product
Correction
13/02/2014 Etest Ertapenem Foam and Medical Recall Class II Hospital
Single Blister Packs (antibiotic Device
susceptibility test). An in vitro
12/02/2014 550 TxT Treatment Table used Medical Recall for Class II Hospital
with PRIMUS, ONCOR and Device Product
ARTISTE Digital Linear Correction
Accelerators
12/02/2014 NICABATE nicotine 2mg/4mg Medicine Recall Class III Wholesale
lozenge blister pack and
NICABATE MINIS MINT nicotine
1.5mg/4mg lozenge tube
12/02/2014 RayStation software versions Medical Recall for Class I Hospital
2.5, 3.0, 3.5, and 4.0 (radiation Device Product
therapy treatment planning Correction
system)
11/02/2014 LUTONIX 014 and 035 OTW Medical Recall Class I Hospital
Drug Coated PTA Dilatation Device
Catheter

Datei Levelvi
11/02/2014 Neptune 2 Rover Ultra (Mobile Medical Recall for Class I Hospital
unit used as surgical fluid/smoke Device Product
waste management system) Correction
11/02/2014 The Binding Site SPAPLuS Medical Recall for Class III Hospital
analyser. An in vitro diagnostic Device Product
10/02/2014 Aerius/Aerial and Aerius/Aerial Medical Recall Class III Consumer
Active Wheelchair Cushion Device
10/02/2014 AMO Tecnis CL Foldable Medical Hazard Alert Class II Hospital
Silicone IOL (Intraocular lens) Device
with OptiEdge Design
(Intraocular lenses indicated for
primary implantation for the
visual correction of aphakia in
adults)
10/02/2014 Infinia, Infinia Hawkeye, Medical Recall for Class I Hospital
Millenium VG, VG Hawkeye and Device Product
VariCam Nuclear Medicine Correction
Systems, All configurations
10/02/2014 Kodak 2100 & 2200 Intraoral X- Medical Recall for Class II Retail
ray System (dental x-ray) Device Product
Correction
10/02/2014 Ponstan Mefenamic Acid 250mg Medicine Recall Class III Wholesale
Capsule Bottle and Capsule
Blister Pack
7/02/2014 AXIOM Artis Systems Medical Recall for Class I Hospital
(fluoroscopic angiographic x-ray Device Product
system) Correction
7/02/2014 Multiple Patient Specific Medicine Recall Class I Hospital
Oncology Medicine
Compounded by Fresenius Kabi
7/02/2014 VersaCell connected to Medical Recall for Class I Hospital
IMMULITE 2000/IMMULITE Device Product
2000 XPi analysers Correction
6/02/2014 Oxoid Legionella Latex Test and Medical Recall Class II Hospital
Oxoid Legionella Penumophila Device
Serogroup 2-14 Test Reagent
(an in vitro diagnostic medical
device (IVD))
5/02/2014 MRI-Stretcher non-magnetic Medical Recall for Class II Hospital
Device Product
Correction
5/02/2014 Powerheart G5s & G5A Medical Recall for Class I Retail
Automatic External Defibrillators Device Product
(AEDs) Correction
5/02/2014 Precision 500D and Proteus Medical Recall for Class I Hospital
XR/a with Wireless Digital Device Product
Radiography Option (WDR1) Correction
(fluoroscopic x-ray system)
5/02/2014 Solar 8000M and Solar 8000i Medical Recall for Class II Hospital
Patient Monitor software version Device Product
5.4, 5.5 or 5.6 (multi-function Correction
patient monitor)

Datei Levelvi
5/02/2014 Spectra Optia Apheresis Medical Recall for Class I Hospital
machine Device Product
Correction
5/02/2014 T-Adaptation Plate 1.3, head 3 Medical Recall Class III Hospital
holes, shaft 8 holes, Stainless Device
Steel, and T-Adaptation Plate
1.3, head 4 holes, shaft 8 holes,
Stainless Steel (orthopaedic
fixation plates)
5/02/2014 Zimmer Segmental System Medical Recall for Class II Hospital
Polyethylene Insert-Size B & Device Product
Size C (Intended to replace the Correction
proximal femur, mid-shaft femur,
distal femur, proximal tibia and/or
total knee in cases that require
extensive resection and
restoration)
4/02/2014 Philips HeartStart XL+ Medical Recall for Class III Hospital
Correction
3/02/2014 Samaritan PDU 400 (automated Medical Recall Class II Retail
external defibrillator) Device
31/01/2014 balanSys Knee System (CR, UC, Medical Recall for Class II Hospital
PS and RP) Device Product
Correction
31/01/2014 IMUKIN interferon gamma-1b Medicine Recall Class II Retail
recombinant human 2 million IU
(100 micrograms)/0.5mL
injection vial
29/01/2014 LCP Condylar Plate 2.4 Shaft, 7 Medical Recall Class III Hospital
Hole Head, 2 Hole (fixation plate Device
used to treat orthopaedic
fractures)
29/01/2014 LCP Plate 2.4, straight, 8 holes, Medical Recall Class III Hospital
length 68 mm, Stainless Steel Device
(fixation plate used to treat
orthopaedic fractures)
29/01/2014 Tytin – Regular Set, Double Spill Medical Recall Class III Retail
50 and 500 capsules (self Device
activating capsules of dental
alloy used as a dental
restorative)
28/01/2014 Horizon Medical Imaging (HMI) Medical Recall for Class I Hospital
products software versions 4.5 to Device Product
and including 11.9 (Radiology Correction
28/01/2014 Zoo Master Pack 3D 1/4" M/H Medical Recall Class III Retail
Fox (elastomeric component for Device
orthodontic applications)
24/01/2014 Holding Forceps for SynReam Medical Recall Class II Hospital
Reaming Rod 2.5 mm (used Device
during surgery to retain an
instrument, reduce a fracture,
spread an osteotomy, or hold an
implant in place)

Datei Levelvi
24/01/2014 Puritan Bennett 840 Ventilator Medical Recall for Class II Hospital
and 700 Series (740 and 760) Device Product
Ventilators Correction
23/01/2014 Activa PC, Activa RC and Activa Medical Hazard Alert Class I Hospital
SC Implantable Deep Brain Device
Stimulators and RestoreUltra
and RestoreSensor Implantable
Spinal Cord Stimulators
Correction
23/01/2014 St. Jude Medical ICD/CRT-D Medical Hazard Alert Class I Hospital
devices programmed to a single Device
VF detection zone with Merlin
Programmer software version
17.2.2 rev. 0
23/01/2014 SynchroMed II Implantable Medical Hazard Alert Class I Hospital
Infusion Pump Device
23/01/2014 Vented Spike with Clearlink (fluid Medical Recall Class I Hospital
transfer set) Device
22/01/2014 Anspach Short Carbide Cranial Medical Recall Class II Hospital
Cutting Burrs - 1.5 mm x 7.5 mm Device
Cylindrical Carbide Drum used
with Short Attachments
22/01/2014 Mosaic Porcine Aortic Medical Hazard Alert Class I Hospital
Bioprosthesis Model 305 and Device
Medtronic Aortic
Obturators/Sizers and iOEA
Charts
22/01/2014 Multiple Manual Pulmonary Medical Recall Class II Hospital
Resuscitators (Single Use) Device
21/01/2014 Xia 3 Titanium Torque Wrench, Medical Recall Class II Hospital
Mantis Redux Torque Wrench & Device
Xia Torque Wrench (used for
final tightening of the blocker on
the head of the pedicle screw
during posterior spinal fusion
surgery)
20/01/2014 BrightView SPECT, BrightView X Medical Recall for Class II Hospital
and BrightView XCT (SPECT/CT Device Product
diagnostic imaging system) Correction
20/01/2014 Osteocalcin assay run on Medical Recall Class II Hospital
IMMULITE 2000 & IMMULITE Device
2000 XPi analysers. An in vitro
20/01/2014 Sorin Perceval S Post-Dilation Medical Recall for Class I Hospital
Catheter Size M (indicated for in Device Product
situ post-dilation of the valve Correction
after implantation)
17/01/2014 Elecsys HIV combi PT assay. An Medical Recall Class II Hospital
(IVD)
17/01/2014 Kodak DirectView DR 7500 Medical Recall for Class II Hospital
System with software version 5.3 Device Product
(diagnostic x-ray system) Correction

Datei Levelvi
16/01/2014 Ceiling mounted rail systems for Medical Recall for Class I Consumer
Liko Overhead Lifts Device Product
Correction
16/01/2014 Novocastra Liquid Mouse Medical Recall Class I Hospital
Monoclonal Antibody. An in vitro Device
Discs with Vancomycin (VA30). Device
device (IVD)
15/01/2014 Magnetom Spectra 3.0 T System Medical Recall for Class I Hospital
(MRI system) Device Product
Correction
15/01/2014 Thermo Scientific MAS Omni- Medical Recall for Class II Hospital
IMMUNE PRO. An in vitro Device Product
13/01/2014 Desktop Pro R7.01 SP2 and Medical Recall for Class I Hospital
Desktop Pro R4.2, R5.0, R5.1, Device Product
R6.0, R6.1 (Linear accelerator Correction
system)
13/01/2014 Matrix Surgical Laparoscopic Medical Recall Class II Hospital
Spatula with Cable (Active Device
endotherapy device)
10/01/2014 Zymed Holter Converter Medical Recall for Class II Hospital
(Cardiology information system Device Product
designed for the collection and Correction
management of
electrocardiography data)
9/01/2014 Innova 3100, Innova 3100IQ and Medical Recall for Class I Hospital
Innova 2100IQ Cardiovascular Device Product
X-ray Imaging Systems Correction
9/01/2014 PET Discovery 600 and PET Medical Recall for Class I Hospital
Discovery 690, with software Device Product
versions pet_mict_plus.44 and Correction
pet_velocity.53 (Nuclear
medicine diagnostic system)
9/01/2014 Precision RXI X-ray Imaging Medical Recall for Class II Hospital
Systems equipped with LCD Device Product
Video Monitor Correction
8/01/2014 Integrity R1.1, R3.0 and Medical Recall for Class I Hospital
R3.1(digital linear accelerator) Device Product
Correction
8/01/2014 Oxford Advance only Medical Recall for Class II Hospital
manufactured prior to July, 2010 Device Product
(Prior to serial number Correction
1007L0001)
7/01/2014 CILAMOX Sugar Free Medicine Recall Class II Retail
(Amoxycillin) 250mg/5mL Syrup
Correction
3/01/2014 Journey BCS Knee Replacement Medical Hazard Alert Class II Hospital
System - Femoral Implant Device

Datei Levelvi
3/01/2014 Total IgE for use with Immulite, Medical Recall for Class II Hospital
Immulite 1000, Immulite 2000, Device Product
Immulite 2000 XPi analysers. An Correction
(IVD)
2/01/2014 Androstenedione assay run on Medical Recall for Class II Hospital
Immulite, Immulite 1000, Device Product
Immulite 2000, Immulite 2000XPi Correction
analysers. An in vitro diagnostic
24/12/2013 Citrate Activated Partial Medical Recall Class I Hospital
Thromboplastin Time (APTT) Device
Cuvettes. An in vitro diagnostic
24/12/2013 cobas 4800 PCR Media Kit, Medical Recall for Class II Hospital
cobas 4800 PCR Urine Sample Device Product
Kit and cobas PCR Female Correction
Swab Kit. An in vitro diagnostic
23/12/2013 STERRAD 100S, STERRAD 50 Medical Recall for Class II Hospital
and STERRAD NX Sterilisation Device Product
Systems Correction
23/12/2013 Trident Tritanium Acetabular Medical Recall Class II Hospital
Window Trials Case Device
20/12/2013 Artis systems running software Medical Recall for Class II Hospital
version VC21B in conjunction Device Product
with a Large Display Correction
20/12/2013 RAPIDLyte Arterial Blood Medical Recall for Class II Hospital
Sampling Line Draw Syringes Device Product
Correction
19/12/2013 EVOTECH Endoscope Cleaner Medical Recall for Class II Hospital
and Reprocessor (ECR) Device Product
Correction
19/12/2013 Laparascopic inserts with tube, Medical Recall Class II Hospital
3.00mm Device
19/12/2013 Pregnancy Iron (30's) Medicine Recall Class II Retail
19/12/2013 VITEK 2 System Medical Recall for Class III Hospital
Device Product
Correction
18/12/2013 Brilliance iCT with Software Medical Recall for Class II Hospital
Version 4.1.0.19260 Device Product
Correction
18/12/2013 Giraffe Stand Alone Medical Recall for Class I Hospital
Resuscitation Systems with Device Product
Blender, Giraffe Warmer Correction
Integrated Resuscitation systems
with Blender, Panda Warmer
with Blender, Panda
Freestanding Warmer Integrated
Resuscitation Systems with
Blender, Resuscitation System
field upgrade kits with Blender

Datei Levelvi
System (intended for use as a Device Product
bridge to cardiac transplantation Correction
in patients who are at risk of
death from refractory end stage
heart failure)
18/12/2013 SuperElastic NiTi Archwires Medical Recall Class II Retail
(intended to provide force to the Device
teeth to effect movement in order
to alter their position)
17/12/2013 CompoStop Flex 3F T&B - Medical Recall Class II Hospital
100/600/1300 - PLT Pooling - Device
processing and leuko reduction
system (Blood donor set)
17/12/2013 Essenta DR X-ray System Medical Recall for Class II Hospital
(Digital diagnostic X-Ray system) Device Product
Correction
16/12/2013 GEMINI TF 64 PET/CT Systems, Medical Recall for Class II Hospital
software versions 3.5.1 and Device Product
3.5.2.1 Correction
16/12/2013 Nova StatStrip and StatSensor Medical Recall for Class II Hospital
Blood Monitoring Systems. An in Device Product
(IVD)
16/12/2013 Philips Expression Information Medical Recall for Class I Hospital
Portal (IP5) (secondary display Device Product
control unit for the Expression Correction
MRI Patient Monitoring System)
13/12/2013 Acuity Central Monitoring Medical Recall for Class II Hospital
Correction
13/12/2013 AQURE Data Management Medical Recall for Class I Hospital
System, Version 1.54. An in vitro Device Product
13/12/2013 BD BACTED FX - Top Unit and Medical Recall for Class II Hospital
Bottom Unit (used to detect Device Product
bacteria and fungi in clinical Correction
specimens)
13/12/2013 KAMRA Corneal Inlay (inserted Medical Recall for Class II Hospital
into the natural cornea to treat Device Product
presbyopia ie, age related Correction
hyperopia (far sightedness))
13/12/2013 Optima XR 220amx, Optima Medical Recall for Class I Hospital
XR200amx with Digital Upgrade Device Product
Mobile X-ray Systems Correction
12/12/2013 APPESE 0.5 ropinirole (as Medicine Recall Class II Wholesale
hydrochloride) 0.5mg tablets
11/12/2013 MEDRAD Veris MR Vital Signs Medical Recall for Class I Hospital
Monitor Device Product
Correction
11/12/2013 SOMATOM CT System Medical Recall for Class I Hospital
Device Product
Correction

Datei Levelvi
10/12/2013 CEM Nosecone for use with Medical Recall for Class II Hospital
CUSA Excel/Excel+ Ultrasonic Device Product
Aspirator Correction
System, ARIA Radiation Device Product
Oncology (treatment plan and Correction
image management application)
and Acuity Radiation Therapy
Simulator
10/12/2013 PLUM LifeCare 5000 Series and Medical Recall for Class I Hospital
PLUM XL Familiy of Infusers Device Product
Correction
Correction
9/12/2013 Inflation bulbs used with Medical Recall for Class III Hospital
Safescope Sigmoidoscopes Device Product
Correction
9/12/2013 Large and Mega Needle Driver Medical Recall Class II Hospital
Endowrist Instruments for da Device
Vinci Surgical Systems
9/12/2013 Precision 500D, Legacy, Medical Recall for Class I Hospital
Prestilix, Monitrol, RFX, SFX, Device Product
Tilt-C, Prestige VH, Prestige SI, Correction
and Prestige SII (diagnostic
fluoroscopic x-ray systems)
6/12/2013 D-10 Dual Program Reorder Medical Recall for Class II Hospital
Pack (used with D-10 Device Product
Haemoglobin Testing System). Correction
device (IVD).
6/12/2013 Viscocel and Viscocel Plus Medical Recall Class I Hospital
(Hydomethylpropcellulose) 2% Device
Prefilled Syringes 1.5mL and
2.0mL
5/12/2013 Dimension Vista Systems - Medical Recall Class I Hospital
Cyclosporine (CSA) Flex reagent Device
cartridge. An in vitro diagnostic
5/12/2013 Sorin Perfusion System - S5/C5 Medical Recall for Class I Hospital
Heart Lung Machine Device Product
Correction
4/12/2013 Carestream DRX Evolution with Medical Recall for Class II Hospital
Full Featured Wall Stand, Device Product
Carestream DRX Evolution with Correction
Carestream Premium Wall Stand
and Kodak DirectView DR 7500
System with Full FeaturedWall
Stand

Datei Levelvi
4/12/2013 Giraffe Stand Alone Medical Recall for Class I Hospital
Resuscitation Systems with Device Product
Blender, Giraffe Warmer Correction
with Blender, Panda Warmer
with Blender, Panda
Freestanding Warmer Integrated
Resuscitation systems with
Blender and Resuscitation
System field upgrade kits with
Blender (infant radiant warmers)
3/12/2013 Integrity, software version R1.1, Medical Recall for Class I Hospital
3.0, and R3.1 (Linear Device Product
Accelerator) Correction
3/12/2013 SANGOFIX IV Administration Medical Recall for Class I Hospital
Set and HEIDELBERG Device Product
EXTENSION TUBING Correction
3/12/2013 Volume Imaging System (XVI), Medical Recall for Class I Hospital
software versions 4.2.1 Device Product
(Electronic Imaging Device (EID) Correction
used with radiation therapy
treatment)
2/12/2013 Gemstar Docking Station (Used Medical Recall for Class I Hospital
as an alternate power source for Device Product
the GemStar infusion pumps and Correction
to charge a GemStar battery
pack)
2/12/2013 LH 750 and LH 780 Medical Recall for Class I Hospital
Haematology System. An in vitro Device Product
2/12/2013 Slimming Factor (also known as Medicine Recall Class I Consumer
Easy Trim, Que She and
Chinese Herbal Diet Pills)
2/12/2013 VITROS Mixing Cup Arrays on Medical Recall for Class II Hospital
VITROS 250 Chemistry Systems Device Product
& VITROS 350 Chemistry Correction
2/12/2013 X-ray Volume Imaging System Medical Recall for Class I Hospital
(XVI), software versions R4.5, Device Product
R4.5.1, R4.6 and R5.0 Correction
(Electronic Imaging Device (EID)
used with radiation therapy
treatment)
29/11/2013 Children's Panadol 1-5 years Medicine Recall Class II Retail
Suspension (paracetamol
24mg/mL) Orange 100 ml and
Strawberry 200 ml
29/11/2013 Instrument Star Unit ML Medical Recall Class II Hospital
(Calibration with ICM4) (part of Device
Brainlab Spine & Trauma
Navigation System)
29/11/2013 Leica M525 F50 Surgical Medical Recall for Class II Hospital
Microscope with XY-Unit Device Product
(surgical light microscope) Correction

Datei Levelvi
29/11/2013 Plum A+ Infusion Pump and Medical Recall for Class III Hospital
Software Module Device Product
Correction
29/11/2013 UniCel DxH 600 & 800 Coulter Medical Recall for Class I Hospital
Cellular Analysis System. An in Device Product
(IVD)
29/11/2013 XiO versions 4.50 and higher Medical Recall for Class I Hospital
28/11/2013 BrainLab Navigation Software Medical Recall for Class I Hospital
Spine and Trauma 3D 2.0 (intra- Device Product
operative image guided Correction
stereotactic localisation system
to enable precision spine and
trauma surgeries)
28/11/2013 Calibration Diskette and Assay Medical Recall for Class II Hospital
Data Disks used with VITROS Device Product
chemistry instruments. An in vitro Correction
28/11/2013 Monitor AC3000 Spring Arm Medical Recall for Class I Hospital
(component of Draeger ceiling Device Product
pendant and light systems) Correction
27/11/2013 HT Connect Peripheral Guide Medical Recall Class I Hospital
Wires (used for percutaneous Device
transluminal Agioplasty (PTA) in
peripheral arteries)
27/11/2013 Patient Data Module (PDM) used Medical Recall for Class I Hospital
with B850, B650, B450, Solar Device Product
8000i, MacLab / ComboLab Correction
(Multifunction patient monitoring)
27/11/2013 Patient Side Manipulators - da Medical Recall for Class II Hospital
Vinci S, Si, Si-e Surgical System Device Product
(robotic surgical unit) Correction
27/11/2013 PET Discovery 610 and Medical Recall for Class I Hospital
Discovery 710 with software Device Product
version pet_coreload.44 and Correction
pet_mfk.44
26/11/2013 CoreValve AccuTrak Delivery Medical Recall for Class I Hospital
Catheter System (DCS) Device Product
(Intended to deliver CoreValve Correction
Transcatheter Aortic Valve,
which is designed to treat severe
aortic valve stenosis without
open-heart surgery or surgical
removal of the native valve)
26/11/2013 Patient Data Module (PDM) used Medical Recall for Class I Hospital
with B850, B650, B450, Solar Device Product
8000i and MacLab / ComboLab Correction
(multifunction patient monitor
module)
26/11/2013 Sysmex Automated Blood Medical Recall for Class I Hospital
Coagulation Analyzer CS-2100i Device Product
and 2000i. An in vitro diagnostic Correction

Datei Levelvi
26/11/2013 THUNDERBEAT TB Series Medical Recall for Class II Hospital
Hand Instrument (used in Device Product
general, laparoscopic and Correction
endoscopic surgeries)
26/11/2013 Zimmer Periarticular Femoral Medical Recall Class II Hospital
Cond Buttress Plate and Zimmer Device
Periarticular Distal Lateral
Femoral Locking Plate
25/11/2013 Micro Well Shuttle Weight used Medical Recall for Class II Hospital
in VITROS 3600 Device Product
Immunodiagnostic Systems and Correction
VITROS 5600 Integrated
Systems
25/11/2013 Zimmer Trabecular Metal Medical Recall for Class II Hospital
Reverse Shoulder System Device Product
Glenosphere & Base Plate (Total Correction
shoulder replacement
prosthesis)
22/11/2013 Children's Panadol (paracetamol Medicine Recall for Class II Retail
100mg/mL) Baby Drops Syringe Product
Correction
22/11/2013 Modular Finishing Instrument Medical Recall Class II Hospital
Tray Assembly (used to store, Device
transport and organise
instrumentation for the
Restoration Modular Instruments
Set)
22/11/2013 Oncaspar (Pegaspargase) Medicine Recall for Class II Hospital
3750IU/5mL Injection Solution Product
(Pack of 1 injection) Correction
22/11/2013 REPLY and ESPRIT Medical Hazard Alert Class I Hospital
Pacemakers interrogated using Device
Orchestra and Orchestra Plus
Programmers
22/11/2013 STERRAD 100NX (Gas Plasma Medical Recall for Class III Hospital
Steriliser) Device Product
Correction
22/11/2013 TWISTER PLUS Rotatable Medical Recall Class II Hospital
Retrieval Device 22mm and Device
26mm (used in flexible
endoscopes as a retrieval device
for foreign bodies, such as
polyps and food boluses)
21/11/2013 A-642100 fixed offset adaptor Medical Recall for Class II Hospital
(used in external prosthesis) Device Product
Correction
21/11/2013 LIKO SlingBar 350, SlingBar Medical Recall Class II Consumer
360, SlingBar Wide 670 and Device
SideBar Standard
21/11/2013 Medfusion 4000 Syringe Infusion Medical Recall for Class II Hospital
Pump Device Product
Correction
21/11/2013 VITROS 3600, 4600, 5600, 5,1 Medical Recall for Class II Hospital
FS Chemistry Systems. An in Device Product
(IVD)

Datei Levelvi
21/11/2013 VITROS Chemistry Products K+ Medical Recall Class I Hospital
Slides. An in vitro diagnostic Device
20/11/2013 Ceiling system for Artis Zee Medical Recall for Class I Hospital
System (Fluoroscopic Device Product
angiographic digital x-ray Correction
system)
20/11/2013 FreeStyle Lite Blood Glucose Medical Recall Class II Consumer
Test Strips (used with FreeStyle Device
Papillon Mini Blood Glucose
Meters). An in vitro diagnostic
19/11/2013 Gemstar Infusion System Medical Recall for Class I Hospital
Device Product
Correction
15/11/2013 Atrium Chest drains that contain Medical Recall Class I Hospital
an Autotransfusion (ATS) Device
System access line (for re-
infusion of autologous blood in
postoperative and trauma blood
loss management)
15/11/2013 Human IgM Kit for use on SPA Medical Recall for Class II Hospital
Plus. An in vitro Diagnostic Device Product
Medical Device (IVD) Correction
15/11/2013 ONCASPAR (pegaspargase) Medicine Recall for Class II Hospital
injection, 750 IU/mL, 5mL vial Product
Correction
15/11/2013 STERRAD Boosters and Medical Recall for Class I Hospital
Adaptors (used in STERRAD NX Device Product
steriliser and contains hydrogen Correction
peroxide sterilant)
14/11/2013 Star Drive Frame Adapters and Medical Recall for Class II Hospital
Positioners (intended to be used Device Product
with stereotactic systems for Correction
neurosurgical procedures for
accurate positioning of
mircoelectrodes, stimulating
electrodes or other instruments
in the brain or nervous system)
14/11/2013 Vessix Generator System Medical Recall Class I Hospital
(portable RF generator used with Device
percutaneous angioplasty
balloon catheter to deliever low
frequency RF energy into the
renal artery)
14/11/2013 ZYM B, API Listeria and API NH Medical Recall Class II Hospital
(bacterial identification reagents Device
and kits). An in vitro diagnostic
13/11/2013 BFT II Analyser Medical Recall for Class II Hospital
Device Product
Correction
12/11/2013 Infinity Acute Care System Medical Recall for Class I Hospital
(IACS) Monitoring Solution Device Product
(Patient monitoring system) Correction

Datei Levelvi
12/11/2013 IS3000 HD Lamp Modules with Medical Recall for Class II Hospital
metal finish (endoscopic Device Product
illumination system used with the Correction
da Vinci Si Vision Cart System
which is a robotic surgical
system)
11/11/2013 ADVIA Chemistry Systems. An in Medical Recall for Class II Hospital
(IVD) Correction
11/11/2013 Stryker NV Excelsior (used to Medical Recall Class II Hospital
assist in the delivery of Device
diagnostic agents) SL-10 90deg
2-Tip, NV Neuroform 3EZ-
3.0x15mm and 3EZ-3.5x15mm
Microcatheters (used with
occlusive devices in the
treatment of intracranial
aneurysms)
8/11/2013 ADAC ARGUS Gamma Camera Medical Recall for Class I Hospital
Systems (Nuclear medicine Device Product
system) Correction
8/11/2013 Ansell Sandel Weighted Safety Medical Recall Class II Hospital
Scalpel Device
8/11/2013 Boston Scientific 13F/15F Medical Recall Class I Hospital
Navigator HD Ureteral Access Device
Sheath Set (used to facilitate the
passage of endoscopes,
urological instruments and for
the injection of fluids into the
urinary tract)
8/11/2013 Epidural Minipack Systems Medical Recall for Class II Hospital
(Epidural anaesthesia kit) Device Product
Correction
8/11/2013 Fresofol 1% MCT/LCT (propofol) Medicine Recall Class II Hospital
500mg/50mL Emulsion for
Intravenous Injection/Infusion
Pre-Filled Syringe
8/11/2013 Imigran Mk II sumatriptan Medicine Recall Class II Consumer
6mg/0.5mL (as succinate)
Injection Syringe
8/11/2013 IN.PACT Amphirion Drug-Eluting Medical Recall Class I Hospital
Balloon (DEB) (used for Device
percutaneous transluminal
angioplasty of small peripheral
arteries)
8/11/2013 ONCASPAR (pegaspargase) Medicine Recall Class II Hospital
injection, 750 IU/mL, 5mL vial
8/11/2013 Teflon Tube T2 Humerus, Sterile Medical Recall Class II Hospital
(Intended to support the Device
exchange of the Ball Tip Guide
Wires for Smooth Tip Guide
Wires for nail insertion)
8/11/2013 Welch Allyn Propaq LT / Propaq Medical Recall for Class II Hospital
802 with Nellcor SpO2 Device Product
(multifunction patient monitor) Correction

Datei Levelvi
6/11/2013 ABL90 FLEX Analyser. An in Medical Recall for Class I Hospital
(IVD) Correction
6/11/2013 Clinac, Trilogy, Trilogy Tx, Medical Recall for Class I Hospital
Novalis Tx and Unique Device Product
accelerators, software versions Correction
7.x, 8.x and 9.0. (Linear
accelerator system)
6/11/2013 PDM module with Frame F5-01 Medical Recall for Class II Hospital
used with CARESCAPE Monitor Device Product
B850 Correction
4/11/2013 ClinActiv and ClinActiv Plus Medical Recall for Class II Hospital
Therapy Surface (used to Device Product
provide pressure relief to aid in Correction
the prevention and treatment of
pressure ulcers)
1/11/2013 AxSYM Valproic Acid Reagent Medical Recall Class II Hospital
(An in vitro diagnostic medical Device
device IVD)
1/11/2013 Homechoice Pro APD System Medical Recall Class II Consumer
(peritoneal dialyser) Device
1/11/2013 i-STAT PT/INR Cartridge Medical Recall Class I Hospital
(prothrombin time test used for Device
monitoring patients receiving oral
anticoagulation therapy) (An in
(IVD))
1/11/2013 Weinmann Medumat Transport Medical Recall for Class I Hospital
Ventilator Device Product
Correction
31/10/2013 CARESCAPE Monitor B850 Medical Recall for Class I Hospital
(with software versions 1.0.12 Device Product
and earlier) and CARESCAPE Correction
Monitor B650 (with software
version 1.1.12 and earlier)
31/10/2013 MIBGen - Iobenguane [I-123] Medicine Recall for Class II Hospital
Injection 2mL and 4mL Product
Correction
30/10/2013 E.cam and Symbia E systems Medical Recall for Class II Hospital
(diagnostic nuclear medicine Device Product
imaging system) Correction
30/10/2013 KABIVEN G 19% 1540mL Medicine Recall Class II Hospital
injection bag
30/10/2013 TRUEtrack and TRUEbalance Medical Recall for Class I Consumer
Blood Glucose Monitoring Device Product
Systems Correction
29/10/2013 MDC PACS R2.3 SP2 HF6 and Medical Recall for Class II Hospital
MDC PACS R2.3 SP2 HF7 Device Product
(Picture, archiving and Correction
28/10/2013 Vygon Nutrisafe Syringe Feeding Medical Recall for Class I Hospital
Correction

Datei Levelvi
25/10/2013 Luminos dRF and Uroskop Medical Recall for Class II Hospital
Omnia systems with Software Device Product
Version VD10 Correction
25/10/2013 OCTREOTIDE SUN octreotide Medicine Recall for Class II Hospital
(as acetate) solution for injection Product
ampoule Correction
25/10/2013 Panbio Barmah Forest Virus IgM Medical Recall Class II Hospital
ELISA (An in vitro diagnostic Device
25/10/2013 RayStation 3.0, 3.5, or 4.0 Medical Recall for Class I Hospital
25/10/2013 Reliance Endoscope Processing Medical Recall for Class II Hospital
System (EPS) used with Device Product
FUJINON G5 and G8 Type Correction
Flexible GI Endoscopes
25/10/2013 Star Excimer Laser System Medical Recall for Class II Hospital
(used to surgically correct visual Device Product
refractive error in corneal Correction
surgery)
25/10/2013 SynReam Medullary Reamer Medical Recall Class II Hospital
Head Ø 8.5 mm (part of the Device
Adolescent Lateral Femoral Nail
and SynReam Reaming System
Instrument Trays)
Na+ Slides and Calibrator Kit 2 Device
(used on VITROS 250/350/5, 1
FS, 4600 Chemistry Systems,
VITROS 5600 Integrated
24/10/2013 Basin Liner within Molnlycke Medical Recall for Class II Hospital
ProcedurePak (surgical Device Product
procedure packs) Correction
24/10/2013 CEDIA Tobramycin II Medical Recall for Class II Hospital
Assay(used for quantitative Device Product
determination of tobramycin in Correction
human serum or plasma) (an in
(IVD))
24/10/2013 Inzii 12/15mm Retrieval System Medical Recall for Class II Hospital
(used as a receptacle for the Device Product
collection and extraction of Correction
tissues, organs and calculi
during laparoscopic procedures)
24/10/2013 Novacell Battery Charger Medical Recall for Class II Hospital
supplied with the BLS-1000 Light Device Product
Source set (light source for Correction
endoscopic procedures)
24/10/2013 Trinica Ratchet Handles Medical Recall for Class II Hospital
(included in the Anterior Lumbar Device Product
Plate (ALP) Instrument Tray) Correction
24/10/2013 Vivid E9 with Software versions Medical Recall for Class I Hospital
112.1.0, 112.1.1, and 112.1.3 Device Product
Correction

Datei Levelvi
23/10/2013 Aequalis Reversed II and Medical Recall Class II Hospital
Reversed Fracture Impactors Device
(supplied as part of Aequalis
Reversed II and Reversed
Fracture Instrument sets,
YKAD83 &YKAD95)
23/10/2013 Brivo CT315/325, Brivo CT385, Medical Recall for Class II Hospital
Optima CT520 and Optima Device Product
CT540 (all configurations) Correction
22/10/2013 ATTAIN HYBRID Guide Wires Medical Recall Class I Hospital
(used to aid the placement of Device
Medtronic transvenous left
ventricular leads in the coronary
vasculature)
22/10/2013 EPIQ 7 Diagnostic Ultrasound Medical Recall for Class II Hospital
System (software version 1.0, Device Product
1.0.1) Correction
22/10/2013 OPTEASE Retrievable Vena Medical Recall Class I Hospital
Cava Filter Device
22/10/2013 Transradial Artery Access Kits Medical Recall Class II Hospital
Device
21/10/2013 Getinge 46-Series Washer Medical Recall for Class II Retail
Disinfector with PACS 300 Device Product
module Correction
21/10/2013 Straight Adjustable Gastric Band Medical Recall Class II Hospital
Device
17/10/2013 GSI Viewer, prior to version Medical Recall for Class I Hospital
2.00-0M on AW and prior to Device Product
version 2.20-0B in AW Server Correction
(Picture archiving and
communication system, PACS)
17/10/2013 IntelliSpace PACS 4.4 (Picture Medical Recall for Class I Hospital
archiving and communication Device Product
system) Correction
17/10/2013 IOLMaster (used for the Medical Recall for Class II Hospital
treatment of axial length, corneal Device Product
curvature, anterior chamber Correction
depth and for the determination
of the white-to-white distance
(WTW) of the human eye, as
well as for the calculation of the
required intraocular lens)
17/10/2013 Optimys Opening Broach Bent Medical Recall Class I Hospital
(Reusable surgical instrument Device
used for opening the medullary
canal)
16/10/2013 Crocodile Size 3 Walker (walking Medical Recall for Class II Consumer
aid) Device Product
Correction
16/10/2013 TDL6000MC Disposable Medical Recall Class II Hospital
Diathermy - Spatula tip with Device
handle (Electrosurgical
electrode)
15/10/2013 da Vinci S Surgical System, Medical Recall for Class II Hospital
IS2000; da Vinci Si Surgical Device Product
System IS3000 Correction

Datei Levelvi
14/10/2013 Discovery NM/CT 670, Optima Medical Recall for Class II Hospital
NM/CT 640, Discovery NM630 Device Product
and Brivo NM615 (all Correction
configurations) (Nuclear
Medicine System)
14/10/2013 Single-Site Bipolar Maryland and Medical Recall for Class III Hospital
Single-Site Curved Needle Driver Device Product
(Reusable endotherapy device Correction
with an endoscope)
14/10/2013 TISSUE-GUARD Family of Medical Recall Class II Wholesale
Products - VASCU-GUARD, Device
DURA-GUARD, PERI-GUARD
and SUPPLE PERI GUARD
(Xenograft)
14/10/2013 Volumed VP7000 Premium, Medical Recall for Class II Hospital
Volumed VP7000 Classic Plus, Device Product
Syramed SP6000 Premium and Correction
Syramed SP6000 Classic Plus
14/10/2013 Vygon Purple Nutrisafe Feeding Medical Recall Class II Hospital
Tube 10 FR Device
11/10/2013 Philips Expression Information Medical Recall for Class I Hospital
Portal - IP5 (Multiparameter Device Product
patient monitor) Correction
11/10/2013 VITEK MS, firmware version Medical Recall for Class II Hospital
3.10 and 3.13 (bacterial and Device Product
fungal identification system Correction
which uses the matrix-assisted
laser desorption / ionization
(MALDI) mass spectrometry
method) (an in vitro diagnostic
10/10/2013 Lifestent Vascular Stent System Medical Recall Class I Hospital
(200 mm stent length) Device
10/10/2013 PEB01H Diathermy Pencil Medical Recall Class II Hospital
(Electrosurgical electrode) Device
10/10/2013 Sapphire Multi Therapy Pump Medical Recall for Class I Hospital
with software Rev09Ver07 Device Product
(Infusion Pump) Correction
10/10/2013 TPS MicroDriver (used for Medical Recall Class II Hospital
surgical procedures involving Device
drilling, reaming, driving wires or
pins, cutting bone and hard
tissue)
9/10/2013 Avance, Amingo, Aisys Medical Recall for Class I Hospital
Anaesthesia Devices (software Device Product
version 8.00) and Avance CS Correction
Anaesthesia Devices (with
software version 10.00)
9/10/2013 Contoura 1000 and 1080 Beds Medical Recall for Class II Hospital
(used to facilitate management Device Product
of very obese patients) Correction
9/10/2013 Ysio, Luminos Agile, Luminos Medical Recall for Class II Hospital
dRF and Uroskop Omnia Device Product
Systems with software Versions Correction
VB10 and VC10 (diagnostic
digital x-ray system)

Datei Levelvi
4/10/2013 ADM/MDM Ball Impactor Tip and Medical Recall for Class II Hospital
ADM Rim Impactor Tip (reusable Device Product
surgical instrument used to Correction
implant Stryker's Automatic Dual
Mobility (ADM) and/or the
Modular Dual Mobility (MDM)
Acetabular Systems)
4/10/2013 Invacare Power Wheelchairs Medical Recall for Class II Consumer
with affected SPJ+ Joysticks and Device Product
MK6i Driver Controls Correction
3/10/2013 BD SoloMed 3-piece syringe with Medical Recall for Class III Wholesale
breakable plunger. Device Product
Correction
3/10/2013 Carestream PACS Client Medical Recall for Class II Hospital
Workstation version 11.3.2.0 / Device Product
11.3.2.4 / 11.4 Correction
3/10/2013 Magstim 90mm High Power Coil Medical Recall Class II Hospital
(used for diagnostic and Device
therapeutic purposes by
stimulating the cortical and
peripheral nerves using the
magnetic field)
3/10/2013 Medtronic CareLink 2090 Medical Recall for Class III Hospital
Programmer (Implantable Device Product
pacemaker programmer) Correction
2/10/2013 B20, B30, B40 Patient Monitors Medical Recall for Class I Hospital
(used for ECG monitoring) Device Product
Correction
1/10/2013 ISE Reference Solenoid Valve Medical Recall for Class I Hospital
for AU400, AU480, AU640, Device Product
AU680, AU2700, AU5400 and Correction
AU5800 Chemistry Analysers.
device (IVD)
1/10/2013 TomoFix Plate Medial Tibia 4 Medical Recall for Class II Hospital
Hole Standard and TomoFix Device Product
Small Proximal Medial Tibia 4 Correction
Hole 112 mm Titanium Sterile
1/10/2013 UniCel DxH 800 and UniCel DxH Medical Recall for Class I Hospital
600 Coulter Cellular Analysis Device Product
1/10/2013 Xia 3 Titanium Torque Wrench & Medical Recall Class II Hospital
Xia 3 Titanium Torque Wrench Device
Short (used for final tightening of
the blocker on the head of the
pedicle screw during posterior
spinal fusion surgery)
27/09/2013 Beckman Coulter LH 750 & 780 Medical Recall for Class I Hospital
Hematology Analysers (An in Device Product
vitro diagnostic device (IVD)) Correction
27/09/2013 PICATO ingenol mebutate Medicine Recall for Class III Wholesale
0.015% / 0.05% (w/w) gel tube Product
Correction
25/09/2013 EPIQ 7 Ultrasound system Medical Recall for Class II Hospital
version 1.0 (Intended for Device Product
diagnostic ultrasound imaging Correction

Datei Levelvi
25/09/2013 HIV Ag/Ab Combo (CHIV) Assay Medical Recall for Class III Hospital
(used with ADVIA Centaur, Device Product
ADVIA Centaur XP and ADVIA Correction
Centaur CP) (an in vitro
diagnostic medical device (IVD))
25/09/2013 Muliple Zimmer Highly Polished Medical Recall for Class II Hospital
Implants (packaged in a Low Device Product
Density Polyethylene (LDPE) Correction
Bag)
25/09/2013 RAPIDPoint 400 Series, Medical Recall for Class II Hospital
RAPIDPoint 500, and RAPIDLab Device Product
1200 Series Analysers Correction
(diagnostic blood gas analyser)
20/09/2013 Stryker Standard Video Cart and Medical Recall for Class II Hospital
Vision Mounting Arm Device Product
Correction
18/09/2013 NX3 Try-In Gel Syringe Refills, Medical Recall Class II Retail
Bleach (dental material used to Device
preview the expected shade of a
tooth restoration before final
cementation)
18/09/2013 Sodium Iodide (I-131) Therapy Medicine Recall Class II Hospital
Capsule
17/09/2013 BBL MGIT Mycobacteria Growth Medical Recall Class II Hospital
Indicator Tube Device
16/09/2013 LOCI Cardiac Troponin I Medical Recall Class II Hospital
Calibrator (used with Dimension Device
EXL Clinical Chemistry Systems)
16/09/2013 NC Sprinter RX Balloon Medical Recall Class II Hospital
Dilatation Catheter ( Angioplasty Device
balloon dilatation catheter)
16/09/2013 VERSA-FX II Femoral Fixation Medical Recall Class II Hospital
System Device
13/09/2013 Argyle Single Lumen Medical Recall for Class II Hospital
Polyurethane Umbilical Vessel Device Product
Catheter Correction
13/09/2013 Artis Systems running Artis VC1x Medical Recall for Class II Hospital
software (Fluoroscopic Device Product
angiographic diagnostic x-ray Correction
system)
13/09/2013 Crocodile Size 3 Walker (walking Medical Recall for Class II Consumer
aid) Device Product
Correction
13/09/2013 DRX Revolution Mobile, DRX Medical Recall for Class II Hospital
Mobile Retrofit & DRX Device Product
Transportable X-ray Systems Correction
13/09/2013 Grifols Australia AHG Cards. An Medical Recall Class I Hospital
(IVD)
13/09/2013 Panbio Barmah Forest Virus IgM Medical Recall Class II Hospital
ELISA. An in vitro diagnostic Device
13/09/2013 Ureterorenoscope 8703-524 Medical Recall Class II Hospital
(rigid ureteroendoscope) Device

Datei Levelvi
12/09/2013 Thermocool SmartTouch Bi- Medical Recall Class I Hospital
Directional Navigation Catheter Device
and Thermocool SmartTouch
Uni-Directional Navigation
Catheter (used to facilitate
the heart and to undertake RF
ablations)
11/09/2013 Cobas b 101 HbA1c Test (used Medical Recall Class II Hospital
to test for diabetes) Device
11/09/2013 Engstrom Ventilator & Aespire Medical Recall for Class II Hospital
View, Aisys and Avance Device Product
Anaesthesia Machines Correction
11/09/2013 FMS Intermediary Tubing with Medical Recall Class I Hospital
One-Way Valve (used with FMS Device
Fluid Management Systems in a
surgical setting by personnel
trained in arthroscopy)
11/09/2013 Vented Spike Adaptor Medical Recall Class I Hospital
Device
10/09/2013 CARDIOHELP-I (Heart-lung Medical Recall for Class I Hospital
bypass system) Device Product
Correction
9/09/2013 Bellatek Zirconia Abutments Medical Recall Class II Retail
Device
9/09/2013 Biomet 3i Dental Implants Medical Recall Class II Retail
Device
9/09/2013 Standard SlingBar 450 Medical Recall for Class II Consumer
Device Product
Correction
6/09/2013 BD Epilor Plastic BD Luer-Lok Medical Recall for Class II Hospital
Loss of Resistance (LOR) Device Product
Syringe (7mL) (Used in Correction
conjunction with an epidural
needle for identifying epidural
space)
6/09/2013 BrightView XCT Medical Recall for Class I Hospital
Device Product
Correction
6/09/2013 Brilliance CT Big Bore Oncology, Medical Recall for Class II Hospital
Brilliance CT Big Bore Radiology Device Product
and Brilliance CT 16 (Air), Correction
software version 3.6.0
6/09/2013 Howard Wright Limited Hospital Medical Recall for Class II Hospital
Beds and Stretchers Device Product
Correction
6/09/2013 Leica Ceiling Mounts MSF-1, Medical Recall for Class II Hospital
MS-1F and MC-1F (Used for Device Product
mounting surgical microscopes) Correction
5/09/2013 ADVIA 1200, 1650, 1800 and Medical Recall for Class I Hospital
2400 Clinical Chemistry Device Product
5/09/2013 Paclitaxel suspension Medicine Recall Class I Hospital
(Abraxane) 150mg in Bag Viaflex

Datei Levelvi
5/09/2013 Robicomb Liceguard Comb Medical Recall Class III Retail
Device
4/09/2013 COBAS INTEGRA 800 Software Medical Recall for Class I Hospital
Version 9864.C2. An in vitro Device Product
4/09/2013 Easypod Auto Injector, model 5.1 Medical Recall Class II Consumer
(Used to inject SAIZEN growth Device
hormone under the skin)
3/09/2013 Application Instrument for Medical Recall Class I Hospital
Sternal ZipFix Device
2/09/2013 Inspira Air Balloon Dilation Medical Recall for Class I Hospital
System (Bronchial balloon Device Product
catheter) Correction
30/08/2013 BacT/ALERT PF Plus Culture Medical Recall Class III Hospital
Bottle. An in vitro diagnostic Device
30/08/2013 Free T3 Assays for use on the Medical Recall Class II Hospital
IMMULITE, IMMULITE 1000, Device
IMMULITE 2000 and IMMULITE
2000 XPi analysers. An in vitro
30/08/2013 Little Coughs Medicine Recall for Class II Retail
Product
Correction
29/08/2013 COGNIS Implantable Cardiac Medical Hazard Alert Class I Hospital
Resynchronization Therapy Device
Defibrillators (CRT-Ds) and
TELIGEN DR & VR Implantable
Cardioveter-Defibrillators (ICDs)
29/08/2013 GENESIS II PS Articular Inserts Medical Recall Class II Hospital
(internal tibial component for Device
knee prosthesis)
28/08/2013 DigitalDiagnost - EasyUpgrade Medical Recall for Class II Hospital
DR (Diagnostic digital x-ray Device Product
system) Correction
28/08/2013 Gas/Water Feeding Valve – Medical Recall Class I Hospital
PTX-OF-B194 (Used with Device
PENTAX GI Video Endoscopes -
90i/90K series and i10/K10
series )
27/08/2013 Navigator Surgical Kit/Tray, Medical Recall for Class II Hospital
Tapered Navigator Surgical Device Product
Kit/Tray, Contra-Angle Torque Correction
Driver Kit, Prosthetic
Instrumentation Kit, Prosthetic
System Driver Tray (Instrument
kits which contains reusable
dental instruments/ trays used to
hold dental instruments during
lab sterilization)
26/08/2013 Berichrom Heparin (used in the Medical Recall Class I Hospital
quantitative and/or qualitative Device
determination of tests associated
with the coagulation cascade)
(An in vitro diagnostic medical
device (IVD))

Datei Levelvi
26/08/2013 Centricity PACS RA1000 Medical Recall for Class I Hospital
Workstation (Picture Archiving Device Product
and Communication System) Correction
26/08/2013 Zimmer Trabecular Metal Medical Recall Class II Hospital
Reverse Glenosphere Distractor Device
26/08/2013 Zimmer Trabecular Metal Medical Recall Class II Hospital
Reverse Glenosphere Helmet, Device
36mm/40mm
23/08/2013 Advantx, Innova 2000, Innova Medical Recall for Class II Hospital
2100 IQ, Innova 3100, Innova Device Product
3100 IQ, Innova 4100, Innova Correction
4100 IQ Cardiovascular X-ray
imaging systems equipped with
Video Monitor Suspension
(Fluoroscopic, angiographic x-
ray system)
23/08/2013 SLE 5000 Ventilator Medical Recall for Class I Hospital
Device Product
Correction
22/08/2013 Endowrist Instruments and Medical Recall for Class II Hospital
Accessories for the da Vinci Device Product
Surgical Systems (Used in Correction
22/08/2013 Sterile K-Wire and Steinmann Medical Recall Class I Hospital
Pin Products (Typically used for Device
temporary fixation of bones in
the extremities)
21/08/2013 Colleague P1.7 CXE Single Medical Recall for Class II Hospital
Channel Pump and Colleague Device Product
P1.7 CXE Triple Channel Pump Correction
(Infusion Pump)
21/08/2013 EasyLink Data Management Medical Recall for Class II Hospital
System, all versions (used for Device Product
connecting multiple IVD Correction
instruments to Laboratory
Information System (LMS))
21/08/2013 OtisMed ShapeMatch Cutting Medical Hazard Alert Class II Hospital
Guides (used to assist in the Device
positioning of knee arthroplasty
components and in guiding the
marking of bone before cutting)
21/08/2013 Sterile Chlorohexidine Medical Recall Class II Wholesale
Gluconate/Alcohol Swabs, Device
Sterile Alcohol Swabs and Sterile
Povidine Iodine Swabs
20/08/2013 Ingenuity TF PET/CT Medical Recall for Class II Hospital
Device Product
Correction
20/08/2013 Of Spiggle & Thesis PTFE Medical Recall Class II Hospital
Ventilation Tubes - Fluoroplastic Device
shepard button and Fluoroplastic
collar button (Tympanostomy
tubes used to ventilate the
middle ear subsequent to otitis
media)

Datei Levelvi
19/08/2013 Discovery MR450, MR750 and Medical Recall for Class II Hospital
Optima MR450w MRI System Device Product
Correction
19/08/2013 SIGMA Fixed Bearing Tibial Medical Recall for Class II Hospital
Inserts - PLI, Cruciate Retaining, Device Product
Posterior Stablised (used as part Correction
of SIGMA Knee System)
16/08/2013 Ceiling Supply Units (CSU) Medical Recall for Class II Hospital
80xx/CSU60xx (Used for Device Product
positioning of medical gas and Correction
vacuum systems)
16/08/2013 Phosphorus Reagent. An in vitro Medical Recall for Class II Hospital
(Used for the quantitation of Correction
phosphorus in human serum,
plasma or urine)
16/08/2013 Vitamin D3 Streuli 300,000IU/mL Medicine Recall Class I Hospital
Ampoules (pack of 10)
Discs with Augmentin Device
(Amoxycillin and Clavulanic acid
- AMC3). An in vitro diagnostic
14/08/2013 Tec 6 and Tec 6 Plus Vaporizers Medical Recall for Class II Hospital
(Used to vaporize anaethesic Device Product
agent Desflurane) Correction
software. An in vitro diagnostic Device Product
12/08/2013 3M Scotchcast Wet or Dry Cast Medical Recall Class II Hospital
Padding Device
12/08/2013 E-Z Clean, L-Wire Laparoscopic Medical Recall Class I Hospital
Electrode Split Stem, 45cm Device
(Single use electrosurgical
electrode)
12/08/2013 Liquichek Sedimentation Rate Medical Recall Class II Hospital
Control, Level 2. An in vitro Device
12/08/2013 MX 16-Slice (Full body CT Medical Recall for Class II Hospital
system) Device Product
Correction
9/08/2013 4.0mm x15mm Small Peripheral Medical Recall Class II Hospital
Cutting Balloon (Monorail & Device
Over-the-Wire ) Microsurgical
Dilatation Device (used for
Percutaneous Transluminal
Angioplasty of obstructive
lesions in peripheral vessels)
and 4.00mm x15mm Flextome
Cutting Balloon (Monorail &
Over-the-Wire) Microsurgical
Dilatation Device (used in
patients with coronary vessel
disease)
9/08/2013 Abraxane nanoparticle albumin- Medicine Recall Class I Hospital
bound paclitaxel 100 mg powder
for injection (suspension) vial

Datei Levelvi
9/08/2013 Fluoprep (Mounting medium for Medical Recall Class III Hospital
immunofluorescence Device
microscopy) - An in vitro
9/08/2013 Secondary 19" Touchscreen - Medical Recall for Class II Hospital
TEGRIS System (Operating Device Product
room device management Correction
system)
8/08/2013 Bio-Absorbable Suture Anchors Medical Recall Class I Hospital
(Soft tissue fixation device) Device
8/08/2013 Fabius Anaesthesia Machine Medical Recall for Class II Hospital
Device Product
Correction
8/08/2013 General Purpose 9 French Medical Recall for Class II Hospital
Temperature Probe, Disposable, Device Product
400 Series Correction
8/08/2013 HemoCue Hb 201 Microcuvettes Medical Recall for Class III Hospital
(an in vitro diagnostic medical Device Product
device (IVD)) Correction
8/08/2013 Portex Blue Line Disposable Medical Recall Class II Hospital
Inner Cannula, 7mm (Reusable Device
tracheostomy tube)
8/08/2013 PyroTITAN Humeral Resurfacing Medical Hazard Alert Class II Hospital
Arthroplasty (CHRA) Device
8/08/2013 Zoo Master Pouch 15 5H 3/8" Medical Recall Class III Retail
Heavy Elephant Elastics Device
(Elastomeric component used
with orthodontic brackets)
7/08/2013 8mm Vector TAS Screw and Medical Hazard Alert Class II Retail
Vector TAS Starter Kit Device
(Orthodontic anchoring screw)
6/08/2013 ORTHO BioVue System Medical Recall for Class I Hospital
Cassettes (blood typing and Device Product
compatibility tests). An in vitro Correction
5/08/2013 Allura Xper FD10 F and Allura Medical Recall for Class II Hospital
FD10/10 (diagnostic, Device Product
5/08/2013 Bond Polymer Refine Red Medical Recall Class II Hospital
Detection System. An in vitro Device
diagnostic medical device
(Immunohisto chemical staining
kit)
5/08/2013 HemoCue Glucose 201 RT Medical Recall Class I Hospital
Microcuvettes, single pack. An in Device
(IVD)
5/08/2013 Phenocell C 0.8% and Phenocell Medical Recall for Class II Hospital
C 3%. An in vitro diagnostic Device Product
2/08/2013 STERRAD 100NX Cassette Medical Recall for Class II Hospital
(Used to provide hydrogen Device Product
peroxide sterilant used in the Correction
STERRAD NX Steriliser)

Datei Levelvi
2/08/2013 ViewPoint 6 Versions 6.2, 6.2.1, Medical Recall for Class II Hospital
6.3 and 6.31 including OB Pro- Device Product
Expert Reporting (Ultrasound Correction
image management software)
1/08/2013 Anastaflo Intravascular Shunt ( Medical Recall Class I Hospital
Carotid artery shunt) Device
1/08/2013 Medtronic Xomed Instrument Medical Recall Class II Hospital
Trays Device
31/07/2013 ACL Top Family of analysers Medical Recall for Class II Hospital
used with HemosIL APTT Device Product
reagent (an in vitro diagnostic Correction
31/07/2013 Durolane 3ml (synovial fluid Medical Recall Class II Hospital
supplementation substance) Device
Testing Discs MEM10 Device
(Meropenem), CT0774B (An in
(IVD))
30/07/2013 ADVIA Centaur Folate Medical Recall for Class II Hospital
ReadyPack, Lot 071218 Kit Lots Device Product
(an in vitro diagnostic medical Correction
device (IVD))
30/07/2013 LPS (Limb Preservation System) Medical Hazard Alert Class I Hospital
Lower Extremity Dovetail Device
Intercalary Component (internal
femoral component)
MicroSlides (an in vitro Device Product
29/07/2013 Cell Marque CDX-2 Medical Recall Class I Hospital
(EPR2864Y*) antibody 7ml - an Device
(IVD)
29/07/2013 FujiFilm Digital Mammography Medical Recall for Class II Hospital
System AMULET (FDR MS- Device Product
1000) Correction
29/07/2013 HypoMon Alarm System (alarm Medical Recall Class II Consumer
for sleep time hypoglycemic Device
episodes)
29/07/2013 VariVac InLine Adjustable Medical Recall for Class II Hospital
Vacuum Wound Drainage Device Product
System with bottle Correction
26/07/2013 C-Qur, C-Qur TacShield and C- Medical Recall for Class II Hospital
Qur V-Patch (used for tissue Device Product
reinforcement during surgery) Correction
26/07/2013 Octagam 5% 10g/200mL Medicine Recall Class II Hospital
24/07/2013 Brilliance iCT and iCT SP up to Medical Recall for Class I Hospital
and including Software Version Device Product
3.2.5 Correction
24/07/2013 Compat Nasogastric Feeding Medical Recall Class II Hospital
Tube 8Fr, 10Fr and 12Fr Device

Datei Levelvi
24/07/2013 Contoura 380 and 480 Bed Medical Recall for Class II Hospital
Device Product
Correction
24/07/2013 Fluorocore 2+ Fast Set Core Medical Recall Class III Retail
Build Up Dental Material, Device
Syringe- Blue Coloured
24/07/2013 HemoCue Urine Albumin Medical Recall Class II Hospital
Microcuvettes (an in vitro Device
24/07/2013 Optimark (gadoversetamide) Medicine Recall for Class III Hospital
Injection bottle 5mL (Used in Product
magnetic resonance imaging) Correction
24/07/2013 Sterile Disposable Syringe 3mL - Medical Recall Class II Retail
Luer Slip Device
23/07/2013 Cobas 4800 HPV Medical Recall Class III Hospital
Amplification/Detection Device
Reagents, 240 tests and 960
tests
23/07/2013 Dimension Vista RF Flex Medical Recall for Class II Hospital
Reagent Cartridge (an in vitro Device Product
22/07/2013 MX8000 IDT 16 Slice CT Medical Recall for Class II Hospital
Scanner Device Product
Correction
22/07/2013 PROMUS Element Plus Medical Hazard Alert Class I Hospital
MONORAIL Everolimus-Eluting Device
Coronary Stent System
19/07/2013 Clearlink System Solution Set Medical Recall Class I Hospital
(Infusion administration set) Device
19/07/2013 D788 pCO2 Membrane Medical Recall for Class I Hospital
(catalogue number 942-063) Device Product
used with Radiometer ABL700 Correction
and ABL800 series analysers
(An in vitro diagnostic medical
device (IVD)
19/07/2013 Medtronic Navigation Framelink Medical Recall for Class I Hospital
(used with Medtronic Navigation Device Product
StealthStation S7 and i7 systems Correction
or a Medtronic Planning Station
for image guided surgery)
19/07/2013 Normal Saline with Phenol (NSP) Medicine Recall Class II Hospital
in 4.5mL fill
19/07/2013 PTFE GRAFTS – ADVANT VXT, Medical Recall for Class II Hospital
FLIXENE, FLIXENE w/IFG, Device Product
ADVANTA SST with expiration Correction
between April 2017 and May
2018
19/07/2013 RaySearch RayStation 3.0 and Medical Recall for Class I Hospital
3.5 (software versions 3.0.0.251, Device Product
3.5.0.16, 3.5.1.6) (Radiation Correction
treatment planning and analysis
software)
18/07/2013 Air Liquide Medical Oxygen Medicine Recall Class III Retail

Datei Levelvi
18/07/2013 Febridol Paracetamol 500mg, Medicine Recall Class I Consumer
100 tablet bottle
17/07/2013 Disposable Breathing Circuit Kit Medical Recall Class II Hospital
Device
17/07/2013 Frameless SRS QA Target Medical Recall Class I Hospital
Pointer (Component of Brainlab Device
Stereotactic System used for
patient positioning during
stereotactic radiosurgery or
radiotherapy procedures using a
linear accelerator)
16/07/2013 Active Care 1015-1 Swivel Medical Recall for Class II Hospital
Sliding Transfer Bench Device Product
Correction
16/07/2013 Fine-Medium Buchanan Medical Recall for Class III Retail
Pluggers (Dental instrument Device Product
used during endodontic Correction
procedures)
16/07/2013 Monaco RTP System (Radiation Medical Recall for Class I Hospital
Treatment Planning System Device Product
Software) Correction
16/07/2013 Mullins Transseptal Catheter Medical Recall Class II Hospital
Introducer 7 French Sheath Device
15/07/2013 Life Standard Package Cavity Medical Recall Class III Retail
Liner (Calcium Hydroxide) Device
15/07/2013 Medrad Hand Controller Sheaths Medical Recall Class II Hospital
(used with Avanta Pedestal Device
Mount Injection System and
Avanta Table Mount Injection
System)
12/07/2013 Alaris System PC Unit (PCU) Medical Recall for Class I Hospital
model 8015, software version Device Product
9.12 Correction
11/07/2013 Medline Cardiac Pack (which Medical Recall Class I Hospital
includes Edwards LifeSciences Device
Suction Wand)
11/07/2013 Olympus OFP-2 Flushing Pump Medical Recall for Class II Hospital
(used with endoscopic irrigation) Device Product
Correction
10/07/2013 Locking Screw Stardrive 2.4mm Medical Recall Class II Hospital
and 2.7mm (self-tapping, 12 mm Device
length, stainless steel.
Orthopaedic bone screw)
10/07/2013 Triathlon Tibial Alignment Ankle Medical Recall for Class III Hospital
Camp Extramedullary Device Product
(Referencing Instrument supplied Correction
with Triathlon Total Knee
Arthroplasty procedure kit)
10/07/2013 Zimmer NexGen Micro Knee Medical Recall Class II Hospital
Implants (Femur, Patella, Device
Articular Surface) and
Provisionals
9/07/2013 ADVIA Chemistry Systems, Medical Recall Class III Hospital
Alkaline Phosphate (ALPAMP) Device
Reagent Kits

Datei Levelvi
9/07/2013 CT0003B AMP10 Ampicillin Medical Recall Class II Hospital
Antimicrobial Susceptibility Device
Testing Discs (An in vitro
9/07/2013 HemoCue Glucose 201 Medical Recall Class II Hospital
Microcuvettes, single packed (an Device
(IVD))
9/07/2013 Liaison Control Mumps IgG (an Medical Recall Class II Hospital
(IVD))
5/07/2013 AirSep Impulse Elite OCD Medical Recall Class II Consumer
(oxygen conserving device) Device
5/07/2013 Infinia Nuclear Medicine Medical Recall for Class I Hospital
Systems, VG and VG Hawkeye Device Product
Nuclear Medicine systems, Helix Correction
nuclear medicine systems, Brivo
NM615, Discovery NM630,
Optima NM/CT640, Discovery
NM/CT670
5/07/2013 Medtronic MiniMed Insulin Medical Recall Class I Consumer
Reservoirs Device
5/07/2013 Riata and Riata ST Silicone Medical Hazard Alert Class I Hospital
Endocardial Defibrillation Leads Device
4/07/2013 iPlan CMF 3.0, iPlan Cranial 3.0, Medical Recall for Class I Hospital
iPlan ENT 3.0, iPlan Flow 3.0, Device Product
iPlan spine 3.0, iPlan Stereotaxy Correction
3.0 (including all subversions)
4/07/2013 NordiPen used with 5mg, 10mg Medical Recall for Class II Consumer
and 15mg Norditropin SimpleXx Device Product
cartridges Correction
4/07/2013 SynchroMed II and SynchroMed Medical Hazard Alert Class I Hospital
EL Implanted Infusion Pump Device
4/07/2013 SynchroMed II and SynchroMed Medical Recall for Class I Hospital
EL Implanted Infusion Pump Device Product
Correction
4/07/2013 SynchroMed II and SynchroMed Medical Hazard Alert Class I Hospital
EL Implanted Infusion Pump Device
human thymocyte
immunoglobulin) 25 mg powder
for infusion vial
3/07/2013 ADVIA Centaur Homocysteine Medical Recall for Class III Hospital
(HCY) Assay used with the Device Product
ADVIA Centaur, Centaur XP, Correction
and Centaur CP systems
3/07/2013 Aliquot Syringe Delivery System Medical Recall for Class II Hospital
Kits (orthopaedic surgical kit, Device Product
used to place injectable synthetic Correction
cortical bone void filler in weak or
diminished bone)
3/07/2013 All Digital Accelerators with Medical Recall for Class I Hospital
Electrons and Beam Modulator, Device Product
MLCi/MLCi2, Agility or Correction
Asymmetric Heads

Datei Levelvi
3/07/2013 GEHC Discovery NM/CT 670 Medical Recall for Class I Hospital
Nuclear Medicine System Device Product
Correction
3/07/2013 GNY Slimming Pills - MSV Medicine Recall Class I Consumer
Strong Version Capsules, ESV
Extra Strong Capsules & RL
Rapid Loss Capsules
3/07/2013 Medisafe Scope Pre-Clean Medical Recall Class III Hospital
Sponge Kit Device
3/07/2013 OASYS Midline Occipital Medical Hazard Alert Class II Hospital
Plate(Intended to promote fusion Device
of the cervical spine and
occipito-cervico-thoracic junction
(Occiput –T3))
2/07/2013 Edwards Lifesciences Suction Medical Recall Class I Hospital
Wand (Used during cardiac Device
surgery for the suction of
excessive fluid from the
pericardium)
28/06/2013 BD MAX Instruments. An in vitro Medical Recall for Class II Hospital
Correction
28/06/2013 Dimension Vista 500 and Medical Recall for Class II Hospital
Dimension Vista 1500 using Device Product
software versions 3.5.1 and 3.6 - Correction
Clinical chemistry analyser. An in
(IVD)
28/06/2013 PSA Assays for use on Immulite, Medical Recall Class II Hospital
Immulite 1000, Immulite 2000 Device
and Immulite 2000 XPi analysers
(an in vitro diagnostic medical
device)
28/06/2013 Red Blood Cell Antibody Medical Recall for Class III Hospital
Identification Reagent - Device Product
Phenocell C 0.8% and Phenocell Correction
C 3%. An in vitro diagnostic
27/06/2013 Cementless Columbus Knee Medical Hazard Alert Class II Hospital
System Device
27/06/2013 Niti-S Biliary Covered Stent Medical Recall Class II Hospital
(Flare-Type) Nagi/Pseudocyst Device
10mm x 3cm
26/06/2013 Consulta CRT-P (Implantable Medical Hazard Alert Class I Hospital
cardiac pacemaker) Device
26/06/2013 Herbs of Gold Olive Leaf Oral Medicine Recall Class II Wholesale
Liquid
26/06/2013 Liposomal Amphotericin Medicine Recall Class I Hospital
(AMBISOME) 50mg in 50ml 5%
glucose infuser device
26/06/2013 Maquet Heater Unit Medical Recall for Class II Hospital
Device Product
Correction
26/06/2013 OSSEOTITE Certain PREVAIL 2 Medical Recall Class II Hospital
Implant 5/4 x 11.5mm Device

Datei Levelvi
25/06/2013 Aquarius GEF08200 Device, V4 Medical Recall Class I Hospital
Software Device
25/06/2013 Mini RPE Screw Assembly Medical Recall Class II Retail
(Orthodontic Appliance System) Device
25/06/2013 Morphine Sulphate solution, Medicine Recall Class II Hospital
50mg in 50mL 039% Sodium
Chloride Syringe (Compounded
patient specific medicine)
25/06/2013 Reduction Instrument for Medical Recall Class II Hospital
Spondylolisthesis, standard, for Device
Matrix 5.5
24/06/2013 Cholestahealth Powder Medicine Recall Class II Consumer
21/06/2013 BD Stem Cell Control Kit (used Medical Recall Class I Hospital
with BD FACSCanto flow Device
cytometers). An in vitro
20/06/2013 Infinia, VG, VG Hawkeye and Medical Recall for Class I Hospital
Helix nuclear medical systems Device Product
Correction
20/06/2013 Perfect Pool 10x10ml, an in vitro Medical Recall Class III Hospital
19/06/2013 AMBISOME (amphotericin B) 50 Medicine Recall Class I Hospital
mg powder for injection vial
19/06/2013 AMH Gen II ELISA Kit. An in Medical Recall Class II Hospital
(IVD).
19/06/2013 Biograph mCT systems running Medical Recall for Class II Hospital
the VG40A or VG40B software Device Product
Correction
19/06/2013 Transpedicular Schanz Screw Medical Recall Class II Hospital
(Bone screw for internal spinal Device
fixation system)
18/06/2013 Dynamic Locking Screw Medical Hazard Alert Class II Hospital
Stardrive 3.7mm self tapping, Device
length 22-70mm and 5.0mm,
length 32-90 mm, Cobalt
Chrome (CoCrMo) sterile
18/06/2013 HeartStart MRx Monitor / Medical Recall for Class I Hospital
Defibrillator Device Product
Correction
18/06/2013 V60 Non-invasive Ventilators Medical Recall for Class I Hospital
Device Product
Correction
17/06/2013 Ceftriaxone (as Sodium) Powder Medicine Recall Class I Hospital
for Injection 1g
17/06/2013 Deep Brain Stimulation (DBS) Medical Recall Class I Hospital
Leads (implantable, neurological Device
electrode stimulator)
14/06/2013 Abbott Medical Optics (AMO) Medical Recall for Class II Hospital
STAR Excimer Laser System Device Product
Correction

Datei Levelvi
14/06/2013 Alaris GP, GP Guardrails, GP Medical Recall for Class I Hospital
Plus & GP Plus Guardrails Device Product
Infusion Pumps Correction
14/06/2013 EZTest steam and Smart-Read Medical Recall Class II Retail
EZTest steam Biological Device
Indicators
14/06/2013 Medtronic Consulta CRT-P Medical Recall Class I Hospital
(Implantable cardiac pacemaker) Device
13/06/2013 5L and 10L Prolystica Ultra Medical Recall for Class II Hospital
Concentrate Alkaline Detergent Device Product
Correction
13/06/2013 IH-1000. An in vitro diagnostic Medical Recall for Class I Hospital
medical device (IVD) Device Product
Correction
13/06/2013 INFUSE/LT Cage Bone Graft Kit Medical Hazard Alert Class I Hospital
(Used for spinal fusion Device
procedures)
13/06/2013 Intuitive Surgical 5mm Cannula Medical Recall for Class II Hospital
and 5mm Flared Cannula Device Product
(Reusable endotherapy cannula) Correction
12/06/2013 Allura Systems: FD10, FD20, Medical Recall for Class II Hospital
FD10/10, Allura Systems with Device Product
OR table: FD10, FD10/10, Correction
FD20/20 (Fluoroscopic x-ray
systems used for
diagnostic/interventional
procedures in cardiovascular and
vascular imaging applications)
12/06/2013 Diclocil (dicloxacillin sodium) Medicine Recall Class II Retail
500mg capsules
12/06/2013 Elements Motor and TF Adaptive Medical Recall for Class III Retail
Starter Kit (Dental motor used Device Product
with endodontic rotary Correction
instruments)
12/06/2013 Medtronic Paradigm Insulin Medical Recall for Class I Consumer
Infusion Sets Device Product
Correction
6/06/2013 APEX Arthroscopy Tubing Set, Medical Recall Class II Hospital
One Connection Device
6/06/2013 CAPD Solution Transfer Set with Medical Recall for Class II Hospital
Locking Connector, Minicap Device Product
Extended Life PD Transfer Set Correction
with Twist Clamp, Minicap
Extended Life PD Transfer Set
with Twist Clamp (Extra Short
and Extra Long)
6/06/2013 Coiled Tube Baxter Infusors Medical Recall Class I Hospital
(Portable Elastomeric Infusion Device
Systems)
6/06/2013 MEVATRON, PRIMUS, ONCOR Medical Recall for Class I Hospital
and ARTISTE Digital Linear Device Product
Accelerators Correction
6/06/2013 Sonopet Console (Ultrasonic Medical Recall for Class I Hospital
Surgical Aspirator System) Device Product
Correction

Datei Levelvi
4/06/2013 DePuy ReClaim Reamer Medical Recall for Class II Hospital
Extension (Supplied as part of Device Product
the ReClaim modular revision hip Correction
system kit)
4/06/2013 DX-D 100 (Mobile diagnostic x- Medical Recall for Class II Hospital
ray generator) Device Product
Correction
3/06/2013 Elekta XVI X-Ray Volume Medical Recall for Class I Hospital
Imager (Electronic Portal Device Product
Imaging Device (EPID) used with Correction
3/06/2013 SYNCHRON Systems Lactate Medical Recall Class I Hospital
(LACT). An in vitro diagnostic Device
3/06/2013 Vitamin A Ampoules Medicine Recall Class II Retail
31/05/2013 Bone Fragments - Milled Biological Hazard Alert Class II Hospital
irradiated femoral head
31/05/2013 Brilliance CT Systems and Medical Recall for Class II Hospital
Gemini & Precedence Systems Device Product
utilising Brilliance CT Correction
31/05/2013 Monaco RTP System (Radiation Medical Recall for Class I Hospital
Treatment Planning System Device Product
Software) Correction
30/05/2013 Glenosphere Orientation Guide Medical Hazard Alert Class II Hospital
Instrument used with the Delta Device
EXTEND Reverse Shoulder
System.
30/05/2013 Medrad Veris MR Vital Signs Medical Recall for Class II Hospital
Monitor - Power cable Device Product
Correction
30/05/2013 Neptune 2 Rover Ultra and Medical Recall for Class I Hospital
Neptune Bronze Rover (Mobile Device Product
unit used as surgical fluid/smoke Correction
waste management system)
29/05/2013 8 mm Fenestrated Bipolar Medical Recall Class II Hospital
Forceps used with da Vinci Device
Standard System (IS1200)
29/05/2013 ECHELON 60mm Endoscopic Medical Recall Class I Hospital
Linear Cutter Reloads, Black Device
(Reload cartridge with two 60mm
long triple-staggered lines of
staples)
29/05/2013 Edwards Lifesciences Medical Recall Class I Hospital
QuickDraw Venous Cannula Device
29/05/2013 G-6-PDH Control Kits, Normal. Medical Recall Class II Hospital
device (IVD)
29/05/2013 Intuitive Surgical EndoWrist Medical Recall Class II Hospital
Instrument Hot Shears Device
Monopolar Curved Scissors
29/05/2013 MIA16 Minimally Invasive Medical Recall for Class II Hospital
Attachment used with the Device Product
Anspach Correction

Datei Levelvi
28/05/2013 Medacta Femoral Stems Medical Recall for Class II Hospital
Device Product
Correction
24/05/2013 Checking Dilator 24-492-15-01 Medical Recall Class II Hospital
(Dilator, De Bakey, 0 1.5mm, Device
19cm)
24/05/2013 DBL Metronidazole Intravenous Medicine Recall Class II Hospital
Infusion, Infusion bag 500mg in
100mL
24/05/2013 Dimension Vista 500 & Medical Recall for Class II Hospital
Dimension Vista 1500 Analysers Device Product
with Software versions 3.4 or Correction
3.5.1 ( An in vitro diagnostic
24/05/2013 GlideScope Video Laryngoscope Medical Recall Class I Hospital
Blades GVL3, GVL4 and GVL5 Device
24/05/2013 MammoDiagnost DR with Medical Recall for Class III Hospital
software release 2.1 Device Product
(mammography system) Correction
24/05/2013 PET VCAR Application Software Medical Recall for Class I Hospital
(installed on Advantage Device Product
Workstation and AW Server Correction
versions: Advantage Workstation
4.6, Volume Share 5 enhanced -
vxtl.11.3, vxtl.11.3 ext1, or
vxtl.11.3 ext2 AW Server 2.0,
Volume Share 5 enhanced -
vxtl.11.3, vxtl.11.3 ext1, or
vxtl.11.3 ext2 )
24/05/2013 PYRENEES Constrained plate 2 Medical Recall Class II Wholesale
Level 36mm Device
22/05/2013 ADVIA Chemistry Total Medical Recall Class II Hospital
Protein_2 reagent (Urine) Device
(UPRO_2). An in vitro diagnostic
22/05/2013 Alere DDS2 Test Kits (Drug Medical Recall Class III Hospital
screening test system). An in Device
(IVD)
22/05/2013 syngo Lab Data Manager Medical Recall for Class II Hospital
Version VA11B and VA12A. An Device Product
(IVD)
21/05/2013 CT0003B AMP10 Ampicillin Medical Recall Class III Hospital
Antimicrobial Susceptibility Device
Testing Discs. An in vitro
20/05/2013 Blackmax, Micromax, Xmax Medical Recall for Class I Hospital
Anspach Pneumatic Drill Device Product
Systems / Hoses without a Correction
pressure relief valve (PRV)
20/05/2013 GAMMA3 Long Nail Kit R2.0 Medical Recall Class II Hospital
LEFT (Intramedullary Nail for Device
fracture fixation)

Datei Levelvi
20/05/2013 Zimmer Air Dermatome (Air Medical Recall for Class II Hospital
powered surgical skin grafting Device Product
device) Correction
17/05/2013 Access 2 Immunoassay System Medical Recall for Class I Hospital
with Software Version 3.4. An in Device Product
(IVD)
17/05/2013 ARCHITECT STAT High Medical Recall for Class III Hospital
Sensitive Troponin-I Calibrators Device Product
and Controls Correction
17/05/2013 Codman Certas Programmable Medical Hazard Alert Class I Hospital
Valves (Hydrocephalic valve) Device
17/05/2013 Dimension Chemistry Wash Medical Recall Class II Hospital
Device
17/05/2013 Integra Ojemann Cortical Medical Recall for Class II Hospital
Stimulator (Electrical antiseizure Device Product
brain stimulator) Correction
17/05/2013 Receptal 1000 mL liner and Medical Recall for Class II Hospital
canister used with the Laerdal Device Product
Suction Unit Correction
16/05/2013 1.5T Signa HDxt, 3.0T Signa Medical Recall for Class II Hospital
HDxt, Signa Vibrant MR Systems Device Product
(Magnetic Resonance Imaging Correction
Systems)
16/05/2013 Berichrom PAI (Plasmin activator Medical Recall for Class III Hospital
inhibitors). An in vitro diagnostic Device Product
16/05/2013 Carbon dioxide absorbent Medical Recall for Class II Hospital
canister for use with the Aespire, Device Product
Aespire View, Avance, Avance Correction
CS2, Aisys, ADU, 9100, M900,
M904, 9300 anaesthesia
systems
16/05/2013 IH-1000 Immunohaemotology Medical Recall for Class I Hospital
Analyser. An in vitro Diagnostic Device Product
Medical Device (IVD) Correction
16/05/2013 LifeCare P5 Premium Bed with Medical Recall for Class II Hospital
side rails Device Product
Correction
15/05/2013 HeartWare Controller Medical Recall for Class I Hospital
Device Product
Correction
15/05/2013 Viper & Viper Plus Powerchairs Medical Recall for Class III Hospital
Device Product
Correction
13/05/2013 BrightView SPECT (single Medical Recall for Class I Hospital
photon emission computed Device Product
tomography system) Correction
13/05/2013 Epix and Direct Drive Medical Recall Class II Hospital
Laparoscopic Grasper Device
10/05/2013 1000mL Receptal System (waste Medical Recall Class II Hospital
disposable suction system) Device

Datei Levelvi
10/05/2013 BioMend Absorbable Collagen Medical Recall Class II Retail
Membrane/Wound Dressing Device
10/05/2013 Medtronic NIM Flex EMG Medical Recall Class I Hospital
Endotracheal Tube Device
10/05/2013 Sterile Adapter for use with the Medical Recall for Class II Hospital
da Vinci S, da Vinci Si, da Vinci Device Product
Si-e (robotic surgical system) Correction
10/05/2013 Versaport Bladeless Optical Medical Recall Class II Hospital
5mm Trocar with Fixation Device
Cannula (Abdominal and
thoracic trocar)
9/05/2013 Brilliance CT 64, Ingenuity Core, Medical Recall for Class II Hospital
Ingenuity Core 128 systems Device Product
using software versions 2.6.1 or Correction
3.5.4 (Computed tomography
full-body x-ray system)
9/05/2013 CoaguChek XS, CoaguChek XS Medical Recall for Class II Consumer
Plus and CoaguChek XS Pro. An Device Product
(IVD)
9/05/2013 Cortex Screw 3.5mm, self- Medical Recall Class III Hospital
tapping, length 60mm, Stainless Device
Steel, sterile (Orthopaedic non-
biodegradable bone screw)
9/05/2013 Guide Wire 2.5mm, with drill tip, Medical Recall Class II Hospital
length 300mm Cobalt-Chrome Device
Alloy (Orthopaedic fixation nail
guidewire)
9/05/2013 Soft Tissue Retractor, small, Medical Recall Class II Hospital
extendible Device
9/05/2013 STF Load Check Indicators Medical Recall Class II Hospital
(ultrasonic bath efficacy Device
indicator)
9/05/2013 T4 Zipper Toga (XL - Tall) Medical Recall Class II Hospital
(Operating room gown) Device
7/05/2013 A-dec 311 Chair and A-dec 361 Medical Recall for Class II Retail
Support Centre Device Product
Correction
7/05/2013 AU2700/AU2700 Plus and Medical Recall for Class II Hospital
AU5400 Clinical Chemistry Device Product
Analysers, an in vitro diagnostic Correction
7/05/2013 Aurum Amiodarone 30mg/mL Medicine Recall Class II Hospital
Pre-Filled Syringe
7/05/2013 Cautery Pen Push Button PTFE Medical Recall Class III Hospital
Coated blade Device
7/05/2013 ProcedurePak - Mater Day Hip Medical Recall Class II Hospital
Arthroscopy Pack Device
6/05/2013 Hill-Rom VersaCare VC 755 Bed Medical Recall for Class II Hospital
Device Product
Correction

Datei Levelvi
3/05/2013 BariAir Therapy System Medical Recall for Class II Hospital
(Provides low air-loss pressure Device Product
management therapy, pulsation, Correction
percussion, turn-assist, flexible
patient positioning capabilities
and built-in scales for large
patients)
3/05/2013 Brainlab Cranial Navigation Medical Recall for Class I Hospital
System, all versions Device Product
Correction
3/05/2013 Elecsys Beta-CrossLaps. An in Medical Recall for Class II Hospital
(IVD) Correction
3/05/2013 Mini C-arm, models InSight and Medical Recall for Class II Hospital
InSight 2 (Fluoroscopic x-ray Device Product
system) Correction
2/05/2013 Dimension TACR (Tacrolimus) Medical Recall Class I Hospital
Flex Reagent Cartridge (DF107), Device
device (IVD)
1/05/2013 LIGACLIP 10mm M/L Medical Recall Class I Hospital
Endoscopic Rotating Multiple Device
Clip Applier (metal ligating clip
applier)
30/04/2013 Elekta Integrity R3.0 Digital Medical Recall for Class II Hospital
Linear Accelerator Device Product
Correction
30/04/2013 Masimo Rad-8 Pulse Oximeters Medical Recall for Class II Hospital
Device Product
Correction
30/04/2013 PANTA Arthrodesis Nail & Medical Recall for Class II Hospital
PANTA XL Arthrodesis Nail Device Product
(Intramedullary tibial nail) Correction
30/04/2013 Tensioner (Instrument used for Medical Recall for Class II Hospital
general orthopaedic repairs Device Product
using implants like cerclage Correction
wires, cables and crimps/clamps)
30/04/2013 VIDAS D-Dimer Exclusion II (An Medical Recall for Class I Hospital
in vitro medical device (IVD)) Device Product
Correction
29/04/2013 Discovery MR450, MR750, Medical Recall for Class II Hospital
MR750w and Optima MR450w Device Product
products, running software Correction
versions DV22.0_V02,
DV22.1_V01, DV23.0_V01 (MRI
System)
29/04/2013 Electrosurgery Probe Plus II Medical Recall Class II Hospital
(Electrosurgical electrodes) & Device
Laparoscopic Banding Kit
29/04/2013 Trima Accel Automated System Medical Recall for Class I Hospital
(Apheresis unit) Device Product
Correction
26/04/2013 Zilver PTX Drug-Eluting Medical Recall Class I Hospital
Peripheral Stent Device

Datei Levelvi
24/04/2013 ACUSON SC2000 System Medical Recall for Class II Hospital
(Ultrasound cardiovascular Device Product
imaging system) when used with Correction
V5M Transducer (which includes
revision 4 of the MPI board)
24/04/2013 LOGIQ S8 with software Medical Recall Class II Hospital
revisions R1.1.1 and R1.5.1, and Device
LOGIQ S7 with software
revisions R1.0.1, R1.0.2 and
R1.0.3 (Diagnostic ultrasound
system)
24/04/2013 RPM Respiratory Gating System, Medical Recall for Class II Hospital
version v1.7.5 with 3D Option Device Product
(Patient respiratory monitoring Correction
system used with radiation
therapy systems)
23/04/2013 BBL DrySlide Oxidase Kit. An in Medical Recall Class II Hospital
(IVD)
23/04/2013 BD Vacutainer Multiple Sample Medical Recall for Class II Hospital
Luer Adapter Device Product
Correction
23/04/2013 Flexible Handle for Simplified Medical Recall Class I Hospital
Universal Nail System (SUN) Device
and the Universal Nail System
(UNI) (Re-usable surgical
instrument supplied as part of
internal fixation system
implantation kit)
23/04/2013 LCP Distal Femoral Plate Medical Recall Class III Hospital
4.5/5.0, right, 19 holes, length Device
436 mm, Titanium Alloy (TAN),
sterile (Orthopaedic fixation
plate)
Products CK-MB Calibrators. An Device Product
(IVD)
22/04/2013 Biograph mCT Systems with Medical Recall for Class II Hospital
VG40 Software (Diagnostic Device Product
imaging system) Correction
22/04/2013 Confidence Spinal Cement Medical Recall Class II Hospital
System Kit Device
22/04/2013 Constellation Pneumatic Medical Recall Class II Hospital
Handpiece, DSP (Ophthalmic Device
surgical instrument handle)
22/04/2013 DuraGen Dural Graft Matrix, Medical Recall Class I Hospital
DuraGen Plus Dural Device
Regeneration Matrix & DuraGen
Suturable Dural Regeneration
Matrix (Dura mater grafts
indicated for the repair or primary
closure of dura (brain and spinal
chord) for regeneration)

Datei Levelvi
22/04/2013 NeuraGen Nerve Guide Medical Recall Class I Hospital
(Indicated for the repair of Device
peripheral nerve discontinuities);
NeuraWrap Nerve Protector
(Indicated to provide nerve
protection following peripheral
nerve surgery)
22/04/2013 OxyCap Adult CO2 Sampling Medical Recall Class II Hospital
Oxygen Mask Device
22/04/2013 Panbio Dengue IgM Capture Medical Recall for Class II Hospital
ELISA, An in vitro diagnostic Device Product
22/04/2013 SYNCHRON Systems Lactate Medical Recall Class II Hospital
(LACT), An in vitro diagnostic Device
19/04/2013 iPlan RT Dose version 4.0 and Medical Recall for Class II Hospital
4.1 (including all subversions) Device Product
(Radiation therapy treatment Correction
planning system)
19/04/2013 Liquichek ToRCH Plus IgM Medical Recall Class I Hospital
Control - Positive (An in vitro Device
19/04/2013 MatrixORTHOGNATHIC Screws; Medical Recall Class I Hospital
MatrixMANDIBLE Screws; Device
MatrixMIDFACE; MatrixNEURO
Screws (Non-sterile and sterile
screws supplied as part of a
craniofacial fixation plate kit)
19/04/2013 Nicolet EEG Wireless Amplifier Medical Recall Class II Hospital
Device
19/04/2013 PCA LifeCare Infusion System Medical Recall Class I Hospital
Device
19/04/2013 Respond Wires (Orthodontic Medical Recall for Class III Retail
wire) Device Product
Correction
19/04/2013 Streptex Group D Latex Medical Recall Class II Hospital
agglutination reagent Device
R30950901, An in vitro
19/04/2013 Tissue Liberator Blade Up Medical Recall Class II Hospital
(Forceps) Device
18/04/2013 IMPAX 5.2 DB Server, version Medical Recall for Class I Hospital
5.2 (Picture archiving and Device Product
communication system, PACS) Correction
18/04/2013 Optima MR430s and MSK 1.5T Medical Recall for Class II Hospital
Extreme (MRI System) Device Product
Correction
Correction
18/04/2013 YUNO Table Extension device Medical Recall for Class II Hospital
Device Product
Correction

Datei Levelvi
17/04/2013 Dimension Tacrolimus (TACR) Medical Recall Class I Hospital
Flex Reagent Cartridge (An in Device
used with Dimension Clinical
Chemistry Systems)
17/04/2013 Elekta Integrity Digital Linear Medical Recall for Class II Hospital
Accelerator, version 1.1 Device Product
Correction
17/04/2013 EnSeal G2 SuperJaw (Used for Medical Recall for Class I Hospital
bipolar coagulation and Device Product
mechanical transection of tissue Correction
during laparoscopic and open
procedures)
17/04/2013 Pulmonary Valve Transplant Biological Hazard Alert Class I Hospital
17/04/2013 SAFETY Blood Collection Sets Medical Recall Class II Hospital
Device
16/04/2013 Optima CT660, Brivo CT385, Medical Recall for Class II Hospital
Discovery PET/CT 610 and Device Product
Discovery PET/CT 710 Systems Correction
16/04/2013 Torix Disposable Toric IOL Medical Recall Class III Hospital
Marking and Alignment System Device
15/04/2013 ADVIA Chemistry Systems Medical Recall for Class III Hospital
Liquid Specific Protein Calibrator Device Product
(an in vitro diagnostic medical Correction
device (IVD))
15/04/2013 Dimension Clinical Chemistry Medical Recall Class II Hospital
Systems HB1C Flex Reagent Device
Cartridge (An in vitro diagnostic
15/04/2013 SJM Confirm External Patient Medical Recall Class III Consumer
Activator Model DM2100A Device
12/04/2013 All GemStar Family of Infusers: Medical Recall for Class I Consumer
GemStar Infusion System - Device Product
Single Therapy, GemStar 7 Correction
Therapy Infusion System
12/04/2013 All GEMSTAR Family of Medical Recall for Class II Hospital
Infusers; GemStar Infusion Device Product
System - Single Therapy; Correction
GemStar 7 Therapy Infusion
System
12/04/2013 All GEMSTAR Family of Medical Recall for Class II Consumer
Infusers; GemStar Infusion Device Product
System - Single Therapy; Correction
GemStar 7 Therapy Infusion
System
12/04/2013 DHS/DCS Screw, sterile Medical Recall Class II Hospital
(Orthopaedic bone screw, non Device
bio-degradable)
12/04/2013 EVOTECH Endoscope Cleaner Medical Recall for Class II Hospital
and Reprocessor (ECR) System Device Product
(Endoscope disinfecting unit) Correction
12/04/2013 EVOTECH Endoscope Cleaner Medical Recall for Class III Hospital
and Reprocessor (ECR) System Device Product
(Endoscope disinfecting unit) Correction

Datei Levelvi
12/04/2013 FreeStyle InsuLinx Blood Medical Recall for Class I Consumer
Glucose Meter (An in vitro Device Product
11/04/2013 All GemStar Family of Infusers: Medical Recall for Class II Consumer
GemStar Infusion System - Device Product
Single Therapy, GemStar 7 Correction
Therapy Infusion System
9/04/2013 ExacTrac (Image guided Medical Recall for Class I Hospital
radiation treatment therapy Device Product
patient positioning system) Correction
9/04/2013 HbA1c Flex Reagent Cartridge Medical Recall Class II Hospital
device (IVD) used with
Dimension Vista Systems)
8/04/2013 Newport HT70 and HT70 Plus Medical Recall for Class II Hospital
Ventilator Device Product
Correction
8/04/2013 PSV Sets (Scalp Vein), Hard, Medical Recall Class II Wholesale
27Gx 3/4" ISO CE Device
5/04/2013 AcrySof CACHET Phakic Lens Medical Recall for Class I Hospital
(Used for the reduction or Device Product
elimination of myopia) Correction
5/04/2013 Imagine Instant Pregnancy Test Medical Recall Class II Retail
Device
5/04/2013 syngo WorkFlow MLR with Medical Recall for Class II Hospital
version VB30C_FP1, VB30E, Device Product
VB35A, VB36A and "Portal Correction
Radiologist" license (radiology
information system used to
process data)
4/04/2013 cobas 8000 modular analyser Medical Recall for Class II Hospital
series, control unit software Device Product
version 03-03 (An in vitro Correction
4/04/2013 DASH, PDM and Tram models Medical Recall for Class II Hospital
(Multiparameter patient monitor) Device Product
Correction
4/04/2013 Locking screw 3.5mm, self Medical Recall Class II Hospital
tapping, length 55mm, stainless Device
steel, sterile (Orthopaedic bone
screw, non-biodegradable)
4/04/2013 STERRAD 100NX and Medical Recall for Class II Hospital
STERRAD 200 Sterilisation Device Product
Systems Correction
4/04/2013 Stryker Suction Irrigation Tips Medical Recall for Class II Hospital
(general purpose Device Product
irrigation/aspiration units) Correction
3/04/2013 epoc BGEM Test Card (blood Medical Recall Class II Hospital
gas, electrolyte and metabolite Device
test card panel), An in vitro
28/03/2013 AQURE POC Management Medical Recall for Class II Hospital
System, software versions 1.4.0 Device Product
to 1.5.3 (An in vitro diagnostic Correction

Datei Levelvi
Analyser; all instrument serial Device Product
numbers with software version Correction
4.11 and prior (An in vitro
28/03/2013 Biomet Oxford Uni Toffee Medical Recall Class II Hospital
Hammer (Reusable surgical Device
instrument used to insert or
remove pins, nails etc)
28/03/2013 Blue Free Strand ORTHOCORD Medical Recall for Class III Hospital
Sutures: Orthocord Blue without Device Product
needles; Orthocord Blue & Violet Correction
without needles; Orthocord Blue
& Violet with needles; Orthocord
Violet/Blue W/ MO 06 NDLE
PK12; Orthocord Violet/Blue W/
OS 06 NDLE PK12 (Sutures
used in general soft Tissue
approximation and or ligation,
including orthopeadic procedures
28/03/2013 CARDIOHELP-1, software Medical Recall for Class I Hospital
version 3.3.0 (Heart-lung bypass Device Product
system) Correction
28/03/2013 cobas 4800 - z 480 (Real time Medical Recall for Class II Hospital
PCR sample preparation, Device Product
amplification and detection Correction
instrument). An in vitro
28/03/2013 Fluoron Gas Tamponades Medical Recall Class II Hospital
(Intraocular injection of Device
ophthalmic gases)
28/03/2013 HemoCue Glucose 201 RT and Medical Recall for Class I Hospital
Glucose 201 DM RT Systems Device Product
(An in vitro diagnostic medical Correction
device (IVD) for the quantitative
detection of blood glucose)
28/03/2013 PROSTIVA RF Model 8930 Medical Recall for Class II Hospital
Generator (Used for minimally Device Product
invasive treatment for patients Correction
with lower urinary tract
symptoms due to benign
prostatic hyperplasia (BPH))
28/03/2013 Pulp Canal Sealer EWT Medical Recall Class III Retail
Standard, Pulp Canal Sealer Device
EWT Bulk Powder Refill (Root
canal sealing material)
27/03/2013 Advantx, Innova 2000, Innova Medical Recall for Class I Hospital
2100 IQ, Innova 3100, Innova Device Product
3100 IQ, Innova 4100, Innova Correction
4100 IQ Cardiovascular X-ray
Imaging Systems equipped with
Video monitor Suspension model
numbers 2236709, 2353620,
2223039-2 and 2270677-2
27/03/2013 Medtronic Paradigm Insulin Medical Recall for Class I Consumer
Pump Device Product
Correction
27/03/2013 One Touch Verio IQ Blood Medical Recall Class I Consumer
Glucose Monitoring System Device

Datei Levelvi
25/03/2013 CentraLink Database Medical Recall for Class II Hospital
Management System, version Device Product
14.0.4 (An in vitro diagnostic Correction
Testing discs for Ampicillin Device
(AMP10). An in vitro diagnostic
Testing discs for Ertapenem Device
(ETP10). An in vitro diagnostic
25/03/2013 Reinforced Endotracheal Tubes - Medical Recall Class I Hospital
Murphy, Magill, Murphy with Device
stylet & Magill with stylet
22/03/2013 Elekta PreciseTreatment Table Medical Recall for Class I Hospital
(Intended as a universal patient Device Product
treatment support and Correction
positioning table for radiation
therapy and simulation use)
22/03/2013 Take 1 Advanced Medium Medical Recall Class III Retail
SuperFast (Dental silicone Device
impression material)
21/03/2013 Kimguard Container Filters 7.5in Medical Recall Class II Hospital
(19cm) round & 9x9in (23x23cm) Device
square (Used for wrapping
medical devices prior to
sterilisation)
Center iX (PIIC iX) software Device Product
release A.01.XX (Central patient Correction
monitoring station)
20/03/2013 ML 301 Examination Lamp Medical Recall for Class II Hospital
Device Product
Correction
19/03/2013 BD HLA-B27 Kit (An in vitro Medical Recall Class II Hospital
diagnostic medical device (IVD)) Device
19/03/2013 FEMME-TAB ED 20/100 Medicine Recall Class II Wholesale
levonorgestrel 100mcg
ethinylestradiol 20mcg film-
coated blister pack (Oral
contraception)
19/03/2013 MX PGE2 3/4 Gellhorn Pessary Medical Recall Class III Retail
Device
19/03/2013 RegenerOss Allograft Block Biological Hazard Alert Class II Hospital
Max/Mand Blocks
PHBR Slides (An in vitro Device
for the quantitative measure of
phenobarbital)
15/03/2013 AMS 800 Artificial Urinary Medical Hazard Alert Class I Hospital
Sphincter Control Pumps Device

Datei Levelvi
15/03/2013 Avance CS2 Anesthesia Medical Recall for Class I Hospital
Carestation Device Product
Correction
15/03/2013 MAQUET QUADROX-i Medical Recall for Class I Hospital
Oxygenators (excluding HLS) Device Product
and Blood Outlet Connectors Correction
15/03/2013 Medtronic NIM TriVantage EMG Medical Recall Class I Hospital
Endotracheal Tube Device
14/03/2013 Alere Cholestech LDX ALT-AST Medical Recall Class II Hospital
Cassette (An in vitro medical Device
device (IVD) used for the
quantitative determination of
alanine aminotransferase (ALT)
and aspartate aminotransferase
(AST) in whole blood)
14/03/2013 Alere Cholestech LDX Medical Recall Class II Hospital
Multianalyte Control (An in vitro Device
diagnostic medical device used
to monitor the performance of
total cholesterol (TC), high
density lipoprotein (HDL),
triglycerides (TRG), glucose
(GLU), alanine aminotransferase
(ALT), and aspartate
aminotransferase (AST) test
procedures on the Alere
Cholestech LDX System)
14/03/2013 IMMULITE 2500 IGF-I (An in Medical Recall for Class II Hospital
(IVD)) Correction
14/03/2013 ML 301 Examination Lamp Medical Recall Class II Retail
Device
13/03/2013 Alere Cholestech LDX hsCRP Medical Recall Class II Hospital
Cassette (An in vitro medical Device
device (IVD) used in the
quantitative determination of C-
reactive protein in whole blood or
serum )
13/03/2013 Archer 0.035 inch (0.89mm) Medical Recall Class I Hospital
Super Stiff Guidewire Device
13/03/2013 D-dimer Test kit for AQT90 Flex Medical Recall Class I Hospital
device (IVD) used as an aid in
the diagnosis of venous
thromboembolism)
12/03/2013 ConMed Linvatec VP1600 HD Medical Recall for Class III Hospital
Still Capture Image System Device Product
(Endoscopic video imaging Correction
system)
12/03/2013 IntelliSpace Portal software Medical Recall for Class I Hospital
version 4.0.2 (Used to remotely Device Product
access data from networked Correction
computers for diagnostic
viewing) used with URL PACS
integration
8/03/2013 Aquae Dry Mouth Gel Medical Recall Class III Wholesale
Hypromellose Oral gel 20mg/g Device

Datei Levelvi
8/03/2013 Artis Zeego systems Medical Recall for Class I Hospital
(Angiographic fluoroscopic digital Device Product
diagnostic x-ray system) with Correction
software Artis
VC20x/VC21A/VD10x that have
a DSA license installed
8/03/2013 Columbia Ultima Bath Chair Medical Recall for Class II Consumer
Device Product
Correction
8/03/2013 ExacTrac versions 6.0.1 and Medical Recall for Class I Hospital
6.0.2 only (Image Guided Device Product
RadiationTherapy Patient Correction
Positioning System)
8/03/2013 ISKD – Intramedullary Skeletal Medical Recall Class II Hospital
Kinetic Distractor (Limb Device
Lengthener)
8/03/2013 LIFEPAK CR Plus and LIFEPAK Medical Recall Class I Retail
EXPRESS Automated External Device
Defibrillators (AED)
7/03/2013 Switch Point Infinity 3 (SPI3) Medical Recall for Class III Hospital
(Computer Interface) Device Product
Correction
6/03/2013 Technetium-99mm Technescan Medicine Recall Class II Hospital
Sestamibi (Compounded
radioactive dose prepared from a
kit as a solution in a syringe for
diagnostic imaging)
6/03/2013 TRIATHLON Baseplate Medical Recall Class III Hospital
Impactor/Extractor (Included in Device
the reusable Triathlon primary or
revision knee implantation kits)
5/03/2013 Artis Zeego Systems Medical Recall for Class III Hospital
(Fluoroscopic angiographic x-ray Device Product
system) Correction
5/03/2013 Transpedicular Schanz Screw, Medical Recall Class II Hospital
6.2mm with dual core, length Device
190/45mm. Titanium alloy (TAN),
dark blue (Bone screw for
internal spinal fixation system)
4/03/2013 Brilliance 64, software version Medical Recall for Class II Hospital
4.0.0.22621 and Ingenuity CT, Device Product
(Whole body computed
tomography x-Ray systems)
4/03/2013 Maxcem Elite (Dental cement) Medical Recall Class II Retail
Device
1/03/2013 Bone Fragments - Milled Biological Hazard Alert Class II Hospital
irradiated femoral head
28/02/2013 BiCision (electrosurgical Medical Recall Class II Hospital
thermofusion and dissection Device
system)
28/02/2013 Chlorhexidine 0.5% in Alcohol Medical Recall Class III Wholesale
70% Device

Datei Levelvi
28/02/2013 Dash 3000/4000/5000 Medical Recall for Class II Hospital
(multiparameter patient monitor) Device Product
& Dash Port 2 (docking station Correction
for Dash 3000/4000/5000)
27/02/2013 All Plum A+ Family of Infusers: Medical Recall for Class I Hospital
Plum A+Single Channel Infusion Device Product
Pump, Plum A+ and A+3 Correction
Infusion Pumps with MedNet
Software
Software
Software
Software
26/02/2013 RaySearch RayStation 3.0 Medical Recall for Class I Hospital
(Radiation treatment planning Device Product
and analysis software) Correction
25/02/2013 Abbott Molecular m 2000sp Medical Recall for Class II Hospital
instrument. An in vitro diagnostic Device Product
25/02/2013 ADEPT 12/14 Modular Head Medical Hazard Alert Class II Hospital
(Used as femoral head Device
component in metal on metal
(MoM) total hip arthroplasty)
25/02/2013 TREPANOSTIKA TP Medical Recall Class I Hospital
Recombinant Kit (An in vitro Device
used for the qualitative
determination of specific
antibodies to Syphilis
(treponema pallidum) in human
serum or plasma)
22/02/2013 Dade Actin FSL Activated Pro Medical Recall Class II Hospital
Thromboplastin Time (APTT) Device
22/02/2013 Drug 4 Cal (KC460) & Drug 4 Medical Recall Class II Hospital
Cal (KC460A) for use with the Device
Dimension Vista System. In vitro
diagnostic medical devices
(IVD).
22/02/2013 HOYA One-Piece Intraocular Medical Recall Class I Hospital
Lenses (IOL) Device
22/02/2013 IPAD Defib Pad, CU-CUA0512F Medical Recall for Class III Retail
(used with I-PAD NF 1200 Device Product
Defibrillator) Correction

Datei Levelvi
Testing Discs for Gentamicin Device
(CN10). An in vitro diagnostic
Testing Discs for Norfloxacin Device
(NOR10). An in vitro diagnostic
22/02/2013 Restylane SubQ Lidocaine Medical Recall Class II Retail
(Used for facial tissue Device
augmentation)
22/02/2013 VITEK 2 60/XL and VITEK 2 Medical Recall for Class I Hospital
Compact systems (In vitro Device Product
diagnostic medical devices (IVD) Correction
used Bacterial identification and
antibiotic sensitivity system)
22/02/2013 Z Hyalin Multipack and Z Hyalin Medical Recall Class II Retail
Plus Multipack Device
21/02/2013 FIAB Ultrasound Transmission Medical Recall Class II Retail
and IPL Transparent Gel Device
21/02/2013 Vitrea Enterprise Suite: Vitrea, Medical Recall for Class I Hospital
Vitrea fX and VitreaCore (Tool Device Product
for analysis of diagnostic Correction
images)
20/02/2013 DLP Single Stage Venous Medical Recall Class I Hospital
Cannula with Metal Tip (Intended Device
for the collection of
deoxygenated blood from the
superior and/or inferior vena
cava during cardiopulmonary
bypass)
20/02/2013 MuscleBack Energy Magnesium Medicine Recall Class II Consumer
Complex 150 g Powder
20/02/2013 Oxoid Xpect Legionella Test Kit Medical Recall Class II Hospital
(R24680), an in vitro diagnostic Device
Defibrillator / Monitor (manual Device Product
defibrillator) Correction
18/02/2013 Enzymatic Creatinine (EZCR) Medical Recall for Class II Hospital
Flex Reagent Cartridge & Device Product
Phosphorus (PHOS) Flex Correction
Reagent Cartridge for use on the
Dimension Clinical Chemistry
System. In vitro diagnostic
medical devices (IVDs)
18/02/2013 Kinevac (sincalide for injection) Medicine Recall Class III Retail
5mcg (5mL vial)
15/02/2013 Bone Unprocessed - Whole Biological Hazard Alert Class II Hospital
femoral head non-irradiated
allograft
15/02/2013 KWIK-QC Acid Fast Stain Slides Medical Recall Class II Hospital
(Microbiology quality control Device
slides). An in vitro diagnostic

Datei Levelvi
15/02/2013 Thromborel S for use with the Medical Recall for Class II Hospital
Sysmex CS-2000i or Sysmex Device Product
CS-2100i analysers (Used for Correction
the determination of prothrombin
time). An in vitro diagnostic
15/02/2013 Vitrea Enterprise Suite : Vitrea, Medical Recall for Class I Hospital
VitreaAdvanced, VitreaCore Device Product
(VitalConnect) and Vitrea fX Correction
(Tool for analysis of diagnostic
images)
14/02/2013 CLOPIDOGREL RBX clopidogrel Medicine Recall Class III Consumer
(as hydrogen sulfate) 75 mg
tablets
13/02/2013 LifeCycle for Prenatal Screening, Medical Recall for Class II Retail
software versions V3.0, v3.1, Device Product
v3.2, v4.0. An in vitro diagnostic Correction
12/02/2013 Artis Zee/Zeego Systems Medical Recall for Class II Hospital
equipped with A 100 plus Device Product
generator (Fluoroscopic Correction
angiographic digital x-ray
system)
12/02/2013 Monaco, Release 3.20.00 - Medical Recall for Class I Hospital
3.20.01 (Radiation Treatment Device Product
Planning System) Correction
11/02/2013 Deep Brain Stimulation (DBS) Medical Recall for Class I Hospital
Leads (implantable, neurological Device Product
electrode stimulator) Correction
11/02/2013 SureSigns Patient Monitors, Medical Recall for Class I Hospital
Model VS2+ Device Product
Correction
System (intended for use as a Device Product
bridge to cardiac transplantation Correction
in patients who are at risk of
death from refractory end stage
heart failure)
8/02/2013 Iconos R200 C20, Iconos R200 Medical Recall for Class I Hospital
T20, Iconos R100, Iconos RHD, Device Product
Luminos RF Classic, Luminos Correction
Fusion, Luminos Select
(Fluoroscopic diagnostic x-ray
systems)
7/02/2013 Allura Xper FD20 Biplane / FD20 Medical Recall for Class I Hospital
Biplane OR table (Flouroscopic Device Product
angiographic digital x-ray Correction
system)
7/02/2013 Ceramic Insertion Tool Assembly Medical Recall Class I Hospital
(Supplied as part of the reusable Device
orthopaedic surgical procedure
kit)
6/02/2013 Reflotron Hb Test Strips, an in Medical Recall for Class II Hospital
(IVD) intended for the Correction
quantitative measurement of
haemoglobin in venous blood
samples

Datei Levelvi
6/02/2013 UniCel DxI 800 Access Medical Recall for Class II Hospital
Immunoassay Systems, Unicel Device Product
DxI 600 Access Immunoassay Correction
Systems, UniCel DxC 660i, 680i,
860i, 880i SYNCHRON Access
Clinical System. In vitro
(IVDs)
5/02/2013 MAQUET Heart Lung Machine - Medical Recall for Class II Hospital
HL30 (Heart-lung bypass Device Product
system) Correction
5/02/2013 Medtronic Navigation O-Arm Medical Recall for Class I Hospital
Imaging System (Digital Device Product
fluoroscopic diagnostic portable Correction
x-ray system)
System, (Radiation therapy Device Product
treatment planning system), Correction
version 11
1/02/2013 Berman Angiographic Balloon Medical Recall for Class II Hospital
Catheters Device Product
Correction
1/02/2013 FCR Go 2 (FCR-MB201) X-Ray Medical Recall for Class II Hospital
System (Digital general purpose Device Product
mobile diagnostic x-ray system) Correction
1/02/2013 Fenwal Transfer Pack 150ml Medical Recall for Class II Hospital
with spike coupler (Blood Device Product
collection/cell-culture container) Correction
1/02/2013 Gambro Conventional Medical Recall for Class II Hospital
Bloodlines; BL200 BD Pre Post, Device Product
BL208 BD & BL223PB Correction
(dialysis/haemodialysis tubing
set)
31/01/2013 Artis Zee Systems equipped with Medical Recall for Class II Hospital
a card collimator Device Product
Correction
31/01/2013 HeartStart Automated External Medical Recall for Class I Retail
Defibrillator (AED) Device Product
Correction
31/01/2013 ISOLINE 2CR6 and 2CT6 Medical Hazard Alert Class I Hospital
Implantable Defibrillation Leads Device
31/01/2013 Level 1 Fast Flow Fluid Warmers Medical Recall for Class I Hospital
with and without Air Detection Device Product
Correction
30/01/2013 AcroMetrix PeliSpy Sero Control Medical Recall Class II Hospital
Type 36 and Type 38. An in vitro Device
30/01/2013 Apex (Multileaf collimator used Medical Recall for Class I Hospital
with Elekta linear accelerators) Device Product
Correction
29/01/2013 ACUSON S2000 Automated Medical Recall for Class II Hospital
Breast Volume Scanner (ABVS) Device Product
Correction

Datei Levelvi
29/01/2013 Correct Quick: Refill - Correct Medical Recall Class III Retail
Quick Light Body 4pk, Refill - Device
Correct Quick Light Body 32pk,
Refill - Correct Quick Medium
Body 4pk, Refill - Correct Quick
Medium Body 32pk, Refill -
Correct Quick Heavy Body 4pk,
Refill - Correct Quick Heavy
Body 32pk (dental impression
material)
25/01/2013 Clopine Suspension - Clozapine Medicine Recall Class II Retail
50mg/ml 100ml bottle
25/01/2013 Hand Switch for Electric Pen Medical Recall Class II Hospital
Drive (electrical drive for use with Device
a range of surgical attachments)
25/01/2013 Razit 20 rabeprazole sodium Medicine Recall Class III Retail
20mg enteric coated tablets
blister pack of 28's
25/01/2013 Ventri and Discovery NM 530c Medical Recall for Class II Hospital
(Full body computed tomography Device Product
(CT) system) Correction
25/01/2013 XVI R3.5, R4.0, R4.2 and R4.5 Medical Recall for Class I Hospital
(X-ray volume imager intended Device Product
to confirm patient positioning and Correction
support decision making in
response to target displacement
resulting from organ deformation
and anatomical movement
during radiation therapy)
22/01/2013 Confidence Spinal Cement Medical Recall Class II Hospital
System 11cc Plus Kit, Device
Confidence Spinal Cement
System Kit
22/01/2013 Corneal Grafts Biological Hazard Alert Class II Hospital
22/01/2013 Medtronic Ardian Symplicity Medical Recall Class II Hospital
Catheter System Device
22/01/2013 Mizuho OSI 5855 Orthopedic Medical Recall for Class II Hospital
Table Top Device Product
Correction
22/01/2013 VITROS Vapor Adsorption Medical Recall Class I Hospital
Cartridge. An in vitro diagnostic Device
21/01/2013 A52103 Navios 10 Colours/3 Medical Recall for Class I Hospital
Lasers, A52102 Navios 8 Device Product
Colours/2 Lasers, A52101 Correction
Navios 6 Colours/2 Lasers
(Navios Flow Cytometers). In
vitro diagnostic medical devices
(IVD)
21/01/2013 XVI R3.5.1, R4.2.1 and R4.5.1 Medical Recall for Class I Hospital
(X-ray volume imager intended Device Product
to confirm patient positioning and Correction
support decision making in
response to target displacement
resulting from organ deformation
and anatomical movement
during radiation therapy)

Datei Levelvi
18/01/2013 Albuterex Xtreme, Albutarex Medicine Recall Class I Consumer
Xtreme and Albutarex Femme
(promoted as fat-loss product)
18/01/2013 Alkaline Phosphatase (ALPAMP Medical Recall Class II Hospital
and ALPDEA), An in vitro Device
18/01/2013 Dimension Tacrolimus (TACR) Medical Recall Class I Hospital
Flex Reagent Cartridge, An in Device
(IVD)
18/01/2013 Fentanyl Intranasal Solution 600 Medicine Recall Class II Hospital
Microgram/2mL (Non sterile
aqueous solution)
18/01/2013 Sofia Influenza A+B FIA Kit. An Medical Recall Class II Hospital
(IVD)
17/01/2013 CEM Nosecone for use with Medical Recall for Class II Hospital
CUSA Excel/Excel+ Ultrasonic Device Product
Aspirator Correction
17/01/2013 MobileDiagnost wDR (mobile x- Medical Recall for Class II Hospital
ray unit) Device Product
Correction
17/01/2013 STA - Liatest vWF: Ag assay Medical Recall for Class II Hospital
used with the STA-R/STA-R Device Product
EVOLUTION analyser. An in Correction
(IVD) for the measurement of
von Willebrand factor.
17/01/2013 Swift Mobile Shower Chair Medical Recall for Class II Retail
(includes Swift Mobile 160 Device Product
shower chair, Swift Mobile 24" Correction
shower chair, Swift Mobile Tilt
shower chair, Swift Mobile Tilt
160 shower chair).
16/01/2013 BM Lactate Test Strips for use Medical Recall Class II Hospital
with the Accutrend Plus, Device
Accutrend GC/GCT/Lactate. An
(IVD)
15/01/2013 Brilliance CT series (6, 10, 16, Medical Recall for Class II Hospital
16 Power, 40, 64, CT Big Bore Device Product
and CT Big Bore Oncology), iCT, Correction
iCT SP, Ingenuity Core,
Ingenuity CT and
15/01/2013 Tracheal tube Medical Recall Class II Hospital
Device
10/01/2013 HAMILTON-T1 Transport Medical Recall for Class I Hospital
Ventilator, Software version 1.1.2 Device Product
Correction
10/01/2013 TempSpan CMT Dental Cement Medical Recall Class III Retail
(used to take dental impressions) Device
9/01/2013 MX 16-Slice CT scanner Medical Recall for Class II Hospital
Device Product
Correction

Datei Levelvi
8/01/2013 ARCHITECT Testosterone Medical Recall for Class II Hospital
Reagent, ARCHITECT Device Product
Testosterone Calibrators and Correction
ARCHITECT Testosterone
Controls. An in vitro diagnostic
8/01/2013 BBL Crystal Enteric/Non- Medical Recall Class II Hospital
fermenter ID Kit, An in vitro Device
8/01/2013 Giraffe Incubator and Giraffe Medical Recall for Class I Hospital
OmniBed with Servo Oxygen Device Product
Control System Correction
8/01/2013 QHVB Pulmonary Allograft Biological Hazard Alert Class I Hospital
Conduit (Human cardiovascular
tissue)
8/01/2013 SOMATOM CTs: Definition Medical Recall for Class II Hospital
Flash, Definition Edge, Definition Device Product
AS and Definition (full body CT Correction
diagnostic x-ray systems)
equipped with software syngo
CT2010A, CT2010B, CT2011A
and CT2012B
7/01/2013 Quadra Trial Broach size 0 Medical Recall Class II Hospital
Device
4/01/2013 Bunnell Life Pulse Patient Medical Recall Class I Hospital
Circuits (Used with Life Pulse Device
High Frequency Ventilator)
4/01/2013 Plum A+ Infusion Pump; Plum Medical Recall Class I Hospital
A+ Infusion Pump with Hospital Device
MedNet Software; Plum A+3
Infusion Pump with Hospital
MedNet Software
2/01/2013 4" Goldvac UltraClean Blade, Medical Recall Class II Hospital
Single Use ABC Needle, 1" Device
UltraClean Needle & Blade with
extended insulation and 6"
UltraClean Blade (Electrosurgical
system electrodes &
accessories)
2/01/2013 A.5650.5 LEM non-sterile Medical Recall for Class II Retail
haemorrhoid suction bander and Device Product
Latex gravorings Correction
Centaur XP HBsAg II Assay. An Device Product
(IVD)
24/12/2012 AutoTac Delivery Handle 400- Medical Recall for Class II Retail
200 and AutoTac Titanium Tack Device Product
Starter Kit 400-270 (Dental Correction
membrane fixation kit)
24/12/2012 cobas IT 1000, version Medical Recall for Class II Hospital
2.00.00.02 to current, ESX 4.1 Device Product
platform virtual server (Analyser Correction
software). An in vitro diagnostic
24/12/2012 ELS Cannulae (Part of Medical Recall Class I Hospital
intravenous catheterisation kit) Device

Datei Levelvi
24/12/2012 Fill-In Refill A1 and A2 Medical Recall Class III Retail
(temporary crown/bridge) Device
24/12/2012 Lumenis VersaCut Tissue Medical Recall for Class I Hospital
Morcellator (soft tissue Device Product
extraction) Correction
24/12/2012 Nobel Replace CC NP 3.5 x Medical Recall Class II Retail
10mm implant (Dental Implant Device
Endosseous)
24/12/2012 Urinary Catecholamines by Medical Recall for Class II Hospital
HPLC Reagent Kits, Automated Device Product
Method on Gilson ASPEC. An in Correction
(IVD)
21/12/2012 A3/A5 Anesthesia Delivery Medical Recall for Class II Hospital
Correction
21/12/2012 Cook Medical Zilver PTX Drug- Medical Recall for Class I Hospital
Eluting Peripheral Stent Device Product
(peripheral artery stent) Correction
21/12/2012 Ventolin Inhaler CFC-free Medicine Recall Class I Retail
Salbutamol 100 microgram (as
sulphate) pressurised inhaler
metered dose, 200 doses, and
ASMOL CFC-FREE Inhaler
Salbutamol 100 microgram (as
sulfate) pressurised inhaler
metered dose, 200 doses.
20/12/2012 Dimension Clinical Chemistry Medical Recall for Class III Hospital
System, Total Iron Binding Device Product
Capacity. An in vitro diagnostic Correction
19/12/2012 Animas 2020 Insulin Infusion Medical Recall for Class I Consumer
Pumps (ambulatory infusion Device Product
pump) Correction
19/12/2012 cobas Product System Manager Medical Recall for Class II Hospital
(PSM) (Analyser software), all Device Product
versions. An in vitro diagnostic Correction
19/12/2012 Liaison Biotrin Parvovirus B19 Medical Recall for Class II Hospital
IgM (testing kit), An in vitro Device Product
18/12/2012 MobileDiagnost wDR (digital Medical Recall for Class II Hospital
diagnostic X-ray imaging system) Device Product
Correction
18/12/2012 SYNCHRON Systems Glucose Medical Recall for Class II Hospital
(GLU) cartridge Reagent. An in Device Product
(IVD)
Analyzer, software versions 4.05 Device Product
and prior. An in vitro diagnostic Correction
17/12/2012 LSX Files, 25mm (Powered Medical Recall Class III Retail
endodontic rasp) Device

Datei Levelvi
14/12/2012 Belmont Instrument Corporation Medical Recall for Class I Hospital
Rapid Infuser (high flow, Device Product
warming infusion pump). Correction
14/12/2012 NARDIL phenelzine 15mg (as Medicine Recall Class III Wholesale
sulphate) 100 tablet bottle
14/12/2012 UCFP Flex Reagent Cartridge Medical Recall Class III Hospital
(Urinary / Cerebrospinal fluid Device
protein assay) used with
Dimension Vista Systems. An in
(IVD)
Centre and Philips IntelliVue Device Product
Information Centre iX (Central Correction
patient monitor unit)
10/12/2012 ARCHITECT Active-B12 Medical Recall for Class II Hospital
(Holotranscobalamin). An in vitro Device Product
10/12/2012 Oxoid Anti-microbial Medical Recall Class II Hospital
Susceptibility Testing Disc for Device
Nitrofurantoin. An in vitro
7/12/2012 ARIA Radiation Oncology Medical Recall for Class I Hospital
System (information system), Device Product
versions: 11.0 below 11.0.55, Correction
Build 11.02.28 and 11.0.34
7/12/2012 Corpuls Defibrillator (Automated Medical Recall for Class I Retail
defibrillator). Software version Device Product
2.0.0 and 2.0.2 Correction
7/12/2012 DigitalDiagnost (Digital Medical Recall for Class II Hospital
diagnostic X-Ray System). All Device Product
systems with Eleva software Correction
version 3.0.x
7/12/2012 Radiometer TCM4 series Medical Recall for Class I Hospital
analyser base units Device Product
(Transcutaneous and non Correction
invasive blood gas analysers)
7/12/2012 X-Ray detectable tracer thread Medical Recall Class II Hospital
included on patient swab / Device
bandage (swabs are included in
Sterile Suture, Catheter and
Lumbar Puncture Kits)
6/12/2012 DBB-06, DBB-07 Haemodialysis Medical Recall for Class I Hospital
Device (haemofiltration dialysis Device Product
unit) Correction
diagnostic X-Ray System) with Device Product
software version 2.0.2 and Correction
2.0.2SP1
6/12/2012 MagNA Pure 96. An in vitro Medical Recall for Class II Hospital
Correction

Datei Levelvi
5/12/2012 AMH Gen II ELISA (clinical Medical Recall for Class II Hospital
chemistry substrate, Anti- Device Product
Mullerian Hormone assay). An in Correction
(IVD).
5/12/2012 Crutches - Forearm Ergo Grip Medical Recall Class II Consumer
Tall and Forearm Ergo Grip Adult Device
(one arm, walking aid crutch)
5/12/2012 DualHemo Mcable for use with Medical Recall for Class II Hospital
the Infinity Acute Care System Device Product
(IACS) (Patient monitoring Correction
system)
5/12/2012 Siroclave Dental Sterilisers Medical Recall Class II Retail
(moist heat autoclave) Device
4/12/2012 TumorLOC (intensity projection Medical Recall for Class I Hospital
dataset software) use with: Device Product
Brilliance CT Big Bore, EBW, Correction
GEMINI LXL, GEMINI TF 16,
GEMINI TF 64 & GEMINI TF Big
Bore (radiology systems)
4/12/2012 Vatech X-Ray System, models: Medical Recall for Class II Retail
Pax-500, Pax-Uni3D, pax- Device Product
Reve3D and Duo3D and Picasso Correction
3D (Dental x-ray system)
4/12/2012 Z Hyalin Multipacks and Z Hyalin Medical Recall Class II Retail
Plus Multipacks Device
(aqueous/vitreous (eye) humour
replacement medium kit)
3/12/2012 Coverstainer Slide Rack Medical Recall Class II Hospital
(automated staining instrument). Device
device (IVD)
3/12/2012 Liko Sabina and Capella Sit-to- Medical Recall for Class II Hospital
Stand Mobile Lifts Device Product
Correction
30/11/2012 Artis Zeego Systems Medical Recall for Class II Hospital
(Fluoroscopic diagnostic x-ray Device Product
system for angiographic Correction
procedures) with SW revision
VC14, VC20 & VC21 in
conjunction with a specific
technical configuration
30/11/2012 IH-Com Kit Full version (Data Medical Recall for Class I Hospital
management and Result Device Product
Interpretation Software for ABO Correction
blood grouping). An in vitro
30/11/2012 Velcade 1mg powder for Medicine Recall for Class II Hospital
injection (VELCADE bortezomib Product
1mg powder for injection vial) Correction
29/11/2012 Advanced Perfusion System 1 Medical Recall for Class I Hospital
(heart-lung bypass machine) Device Product
Correction
29/11/2012 Welch Allyn Schiller AG 1500 Medical Recall for Class III Hospital
Monitor (multi parameter patient Device Product
monitor) Correction

Datei Levelvi
28/11/2012 Clinical Chemistry Phenobarbital Medical Recall Class II Hospital
diagnostic X-Ray System) All Device Product
systems with Eleva software Correction
version 2.1.3
28/11/2012 ENSEAL G2 Curved and Straight Medical Recall Class II Hospital
Tissue Sealer Devices (used in Device
28/11/2012 Phenobarbitol Reagent (used Medical Recall Class II Hospital
with ADVIA Chemistry System). Device
device (IVD)
27/11/2012 2.7mm Self-Tapping Cortex Medical Recall Class II Hospital
Screw (internal fixation device) Device
27/11/2012 Active Knee System - Patella Medical Hazard Alert Class II Hospital
Insert (Used as a component in Device
total knee replacement)
27/11/2012 DR0850M, Oxoid Staphytect Medical Recall Class II Hospital
plus 100 tests (used for the Device
identification of Staphlococcus
aureus). An in vitro diagnostic
26/11/2012 Ardis Inserter (intended for Medical Recall for Class I Hospital
delivery of the Ardis interbody Device Product
spacer into the prepared disc Correction
space)
23/11/2012 Brilliance 64 system with Medical Recall for Class II Hospital
software version 4.00xx516 and Device Product
Ingenuity CT system running Correction
software version 4.00xx518 (full
body CT systems)
23/11/2012 CLINITEK Atlas and Chek-Stix Medical Recall for Class III Hospital
Positive Urinalysis Control Device Product
Solutions. An in vitro diagnostic Correction
23/11/2012 GlideScope Video Laryngoscope Medical Recall Class I Hospital
Blades GVL3, GVL4 and GVL5 Device
(used for intubation)
23/11/2012 Replace Select Tapered TiU RP Medical Recall Class III Retail
4.6x16mm (fully imbedded dental Device
implant)
23/11/2012 Table pallet for use with Medical Recall for Class II Hospital
Discovery NM/CT 670 & Device Product
Discovery NM630 (Diagnostic full Correction
body CT X-ray system)
22/11/2012 Alaris GP Large Volumetric Medical Recall for Class II Hospital
Pump (general purpose infusion Device Product
pump) Correction
22/11/2012 Biomet 2.5MM offset tibial tray Medical Hazard Alert Class II Hospital
adaptor (tibial component of Device
knee joint prosthesis)
22/11/2012 Coffee Shape Slimming Green Medicine Recall Class II Retail
Coffee

Datei Levelvi
22/11/2012 MEDRAD Avanta Hand Medical Recall Class II Hospital
Controller Sheath (multi-phase Device
contrast medium injection
system)
22/11/2012 Steris Reliance 130L Cart Medical Recall for Class II Hospital
Washer (decontamination Device Product
washer utensil) Correction
21/11/2012 Access Immunoassay System, Medical Recall for Class II Hospital
Access 2 Immunoassay System, Device Product
Synchron LXi 725 Clinical Correction
System, UniCel 600i Synchron
Access Clinical System. In vitro
diagnostic medical devices (IVD)
21/11/2012 Amvisc Plus 0.8mL (Aqueous/ Medical Recall Class II Hospital
vitreous humour replacement Device
medium (eye))
21/11/2012 Automatic Quality Control (AQC) Medical Recall for Class III Hospital
Cartridge for use with the Device Product
RAPIDLab 1200 Series, Correction
RAPIDPoint 400 Series and
RAPIDPoint 500 Analysers. In
(IVD)
21/11/2012 Immulite / Immulite 1000 XPi Medical Recall for Class II Hospital
IGF-1 and Immulite 2000 / Device Product
Immulite 2000 XPi IGF-1. An in Correction
(IVD)
21/11/2012 MOBICATH Bi-Directional Medical Recall Class I Hospital
Guiding Sheath, small curve Device
(used to introduce cardiovascular
catheters)
21/11/2012 Nihon Kohden Defibrillator (semi- Medical Recall for Class I Hospital
automated defibrillator) Device Product
Correction
16/11/2012 Adult Circuit Tubing (Oxygen Medical Recall Class II Hospital
therapy delivery system) Device
15/11/2012 "PROFEMUR R" PROX BODY Medical Hazard Alert Class II Hospital
PLASMA SPRAYSTD3 (femoral Device
component of a hip joint
prosthesis)
15/11/2012 ACL ELITE, ACL ELITE PRO, Medical Recall for Class II Hospital
ACL 8000, ACL 9000 and ACL Device Product
10000 (coagulation analysers) Correction
15/11/2012 A-dec 200 Dental Chair Medical Recall for Class II Retail
(examination chair) Device Product
Correction
15/11/2012 SonoSite NanoMaxx Ultrasound Medical Recall for Class II Hospital
System, version 60.80.101.025 Device Product
Correction
14/11/2012 ADVIA Centaur and Centaur XP Medical Recall for Class II Hospital
Instrument Systems (immuno- Device Product
assay analysers). An in vitro Correction

Datei Levelvi
14/11/2012 Rayner T-Flex Aspheric 623T Medical Recall Class I Wholesale
Intraocular Lens (Posterior Device
chamber intraocular lenses)
14/11/2012 YUNO Extension Device (used Medical Recall for Class II Hospital
to support and stabilise the Device Product
patient's body during a surgical Correction
procedure)
13/11/2012 DRX-1 System Console Medical Recall for Class I Hospital
(radiation therapy digital imager) Device Product
Correction
13/11/2012 VIPER 8, 9 & 10mm Large Medical Recall Class II Hospital
Diameter Polyaxial Screws, Device
Lengths 70, 80 & 100 mm (To
provide immobilisation and
stabilisation of spinal segments
in the treatment of instabilities or
deformities of the thoracic,
lumbar, and sacral spine)
HPT Reagent. An in vitro Device
12/11/2012 Access hLH Calibrators used Medical Recall Class II Hospital
with Access Immunoassay Device
12/11/2012 Mammomat Inspiration Medical Recall for Class II Hospital
(diagnostic mammography X- Device Product
Ray system) Correction
9/11/2012 AU5800 diluted detergent tank Medical Recall for Class II Hospital
used with AU5800 Clinical Device Product
Chemistry Analyser. An in vitro Correction
8/11/2012 ADVIA Centaur/Centaur XP/ Medical Recall Class II Hospital
Centaur CP HBcTotal (HBcT) Device
Kits. An in vitro diagnostic
8/11/2012 Micro Curved Attachment (MCA) Medical Recall Class II Hospital
and MCA Cutting Burrs Device
(Intended for use in delicate
bone in otologic (ear) procedures
such as cochleostomy)
8/11/2012 Multiple assays used with ADVIA Medical Recall for Class II Hospital
Centaur, ADVIA Centaur XP, Device Product
ADVIA Centaur CP Systems: Correction
Theophylline 2, Procalcitonin,
Folate, DHEA-SO4, CA 19-9, BR
Assay for CA 15-3, BR Assay for
CA 27.29, BNP (B-type
Natriuretic Peptide), In vitro
(IVDs)
8/11/2012 Spacelabs Healthcare Qube Medical Recall for Class II Hospital
Compact Monitor (Multi Device Product
parameter transportable patient Correction
monitor)
8/11/2012 STERRAD CYCLESURE 24 Medical Recall Class II Hospital
Biological Indicators (sterilisation Device
process indicator)

Datei Levelvi
6/11/2012 Haag-Streit International - Medical Recall for Class II Retail
Tonometer Measuring Prisms Device Product
(an ophthalmic device used to Correction
measure eye ocular
pressure/tension).
5/11/2012 BioPlant Curved Syringe, Medical Recall for Class II Retail
multiple doses, BioPlant Intro Device Product
Pack (synthetic dental bone Correction
grafts)
2/11/2012 PAD 300/PAD 300P Public Medical Recall for Class I Retail
Access Defibrillators (PAD) Device Product
(Semi-automated defibrillator) Correction
1/11/2012 Cobas 8000 Patient sample and Medical Recall for Class II Hospital
control recovery on Cobas c Device Product
701/702 modules (clinical Correction
chemistry analyser). An in vitro
1/11/2012 Cobas IT 3000 version 2.03.04 Medical Recall for Class II Hospital
to 2.04.00, Cobas 8000 Data Device Product
Manager version 1.02.02 to Correction
1.02.05, Cobas INTEGRA 400
and Cobas INTEGRA 400 Plus.
In vitro diagnostic medical
devices (IVD).
1/11/2012 Dimension Vista ALP Calibrator Medical Recall Class III Hospital
(clinical chemistry enzyme). An Device
in vtiro diagnostic medical device
(IVD)
1/11/2012 Lactate membrane for ABL700 Medical Recall for Class II Hospital
series and ABL800 series blood Device Product
gas analysers (Part 942-066, Correction
D7077) . An in vitro diagnostic
31/10/2012 Cordis ExoSeal Vascular Medical Recall Class II Hospital
Closure Device (femoral artery Device
compression device)
31/10/2012 FlexiView 8800 Mobile C-Arms Medical Recall for Class II Hospital
(Mobile, general-purpose, Device Product
system)
31/10/2012 HeartWare Sterile Surgical Tool Medical Recall Class III Hospital
Sets (Supplied as part of the Device
HeartWare Ventricular Assist
System, artifical heart (HVAS))
31/10/2012 OEC 6800 MiniView C-arms Medical Recall for Class II Hospital
(Mobile, general-purpose, Device Product
system)
31/10/2012 SureSafe Wraps and Drapes Medical Recall Class II Hospital
Device
30/10/2012 Extended Brilliance Workstation Medical Recall for Class I Hospital
with running software versions Device Product
4.0.2, V4.5.2 or V4.5.3 (To Correction
perform offline measurement and
manipulation of CT images,
diagnostic X-ray system)

Datei Levelvi
30/10/2012 Liquid Assayed Multiqual Medical Recall for Class III Hospital
Premium (multi analyte control Device Product
material). An in vitro diagnostic Correction
30/10/2012 OriGen Syringe DMSO (Used for Medical Recall Class II Hospital
Research Use Only) Device
29/10/2012 Encore 26 Advantage Kit & Medical Recall for Class II Hospital
Encore 26 Advantage Kit, 5 pack Device Product
(Used to perform general Correction
intravascular procedures)
29/10/2012 Essenta DR Compact (Digital Medical Recall for Class II Hospital
diagnostic X-Ray system) Device Product
Correction
29/10/2012 Monitors B20 or B40 Software Medical Recall for Class I Hospital
version VSP-A_1.10 (or earlier) Device Product
(Multiparameter Patient Monitor) Correction
29/10/2012 Muscletech Hydroxystim 3s, 18s, Medicine Recall Class I Consumer
110s and 200s Capsules
29/10/2012 Nihon Kohden Defibrillator Medical Recall for Class I Hospital
CardioLife, Model Number: TEC Device Product
5521 & 5531 (Semi-automated Correction
defibrillator)
26/10/2012 Jurlique Grapefruit Essential Oil Medicine Recall Class III Retail
10mL
26/10/2012 S500 Hi-Lo Bed (General Medical Recall Class III Retail
Purpose Bed) Device
24/10/2012 ARIA Oncology Information Medical Recall for Class I Hospital
System, version 11 (A suite of Device Product
software modules designed to Correction
manage the entire process of a
patient's course of treatment
including treatment plans and
image management)
24/10/2012 CD7 Mouse Monoclonal Medical Recall Class II Hospital
Antibody (MRQ-12) 1ml Device
concentrate and CD7 Mouse
Monoclonal Antibody (MRQ-12)
0.5ml concentrate (T-cell
markers used in
immunohistochemistry). An in
(IVD)
24/10/2012 CT0034B Nitrofurantoin 100ug Medical Recall Class II Hospital
F100 Antimicrobial Susceptibility Device
Discs. An in vitro diagnostic
23/10/2012 Bio-Rad Multispot HIV-1 / HIV-2 Medical Recall Class I Hospital
Rapid Test. An in vitro diagnostic Device
23/10/2012 GE Corometrics Qwik Connect Medical Recall Class II Hospital
Plus Spiral Electrodes (single Device
use electrodes used for
electrocardiographs)
23/10/2012 ORT100 Neurosurgical Table Medical Recall for Class II Hospital
(for Intra-operative MRI Suites) Device Product
Correction

Datei Levelvi
23/10/2012 PSX Proximate Skin Staple Medical Recall Class II Hospital
Extractor (staple remover) Device
23/10/2012 Resuscitation Systems with Medical Recall for Class I Hospital
blender field upgrade installed in Device Product
GE Giraffe and Panda Warmers Correction
(infant radiant warmer)
23/10/2012 syngo WorkFlow SLR (Radiology Medical Recall for Class II Hospital
workflow software). Product Device Product
versions: VA31A SP1, VA31A Correction
SP2 & VA31A SP3
22/10/2012 BacT/ALERT 3D B.40.xx Medical Recall for Class II Hospital
Firmware (Automated blood Device Product
culture incubator/growth Correction
detector). An in vitro diagnostic
22/10/2012 Elecsys Thyroglobulin assay Medical Recall for Class II Hospital
used with the Elecsys Modular Device Product
Analytics analysers An in vitro Correction
22/10/2012 Quantiferon (QFT) Gold Tubes, Medical Recall Class II Hospital
QFT Gold Unitised Pack, TB Ag Device
Tubes 100ct, QFT Gold Tubes
(Nil & TB & Mitogen) High
Altitude. An in vitro diagnostic
22/10/2012 Various mass spectrometers - Medical Recall for Class II Hospital
Quattro micro, ACQUITY TQD, Device Product
Quattro Premier XE, Xevo TQ; In Correction
vitro diagnostic medical devices
(IVD's)
19/10/2012 Blooms Melt (weight loss Medicine Recall for Class III Retail
formula), 60 Vege Capsules Product
Correction
18/10/2012 Apex K2 Modular Hip Medical Hazard Alert Class II Hospital
Replacement System (total joint Device
prosthesis)
18/10/2012 MOSAIQ (Radiation Oncology Medical Recall for Class I Hospital
Information System). All releases Device Product
pre version 2.41 Correction
16/10/2012 ChromID Strepto B agar (Used Medical Recall Class II Hospital
for screening of S. agalactiae Device
carriage in pregnant women and
potential infections in newborns).
An in-vitro diagnostic medical
device (IVD)
16/10/2012 StreamLAB Automation Medical Recall for Class II Hospital
Solutions (Clinical Chemistry Device Product
Sample Processors). An in-vitro Correction
11/10/2012 Canon CXDI-70C Wireless and Medical Recall for Class III Hospital
CXDI-80C Wireless (Computed Device Product
Radiographic System) Correction
Diagnostic X-ray System) Device Product
Correction

Datei Levelvi
11/10/2012 Kryptonite Bone Cement / Medical Recall for Class III Wholesale
Kryptonite X-Radiopaque Bone Device Product
Cement (Intended for use as a Correction
self-setting bone void filler for
bony voids or gaps that are no
intrinsic to the stability of the
bony structure)
11/10/2012 Plum A+ Pump Version 11.6 and Medical Recall for Class II Hospital
Plum A+ Pump Version 13.4 Device Product
Med Net ABG Driver (general Correction
purpose infusion pump)
11/10/2012 Zoo Pack Elastics Master Pack Medical Recall Class III Retail
2E 3/16 Hvy Kangaroo Device
(Orthodontic elastic bands)
10/10/2012 IMMULITE 1000, 2000, 2000 XPi Medical Recall for Class III Hospital
- IGF-I Control Module (Used for Device Product
the detection of insulin like Correction
Growth Factor hormone). An in
(IVD)
10/10/2012 IMMULITE 2000 / IMMULITE Medical Recall for Class III Hospital
2000 XPi ACTH Control module Device Product
(Used for the detection of Correction
Adrenocorticotropic hormone).
device (IVD)
10/10/2012 INFANRIX HEXA injection Medicine Recall Class II Retail
composite pack (pre-filled
syringe and vial)
10/10/2012 Mobile Detector Holder for Medical Recall for Class III Hospital
DigitalDiagnost System (Digital Device Product
diagnostic x-ray System). Correction
Models: Single Detector, Dual
Detector, Release 3
10/10/2012 Siemens AX System (Digital Medical Recall for Class II Hospital
fluoroscopicc x-ray system) fitted Device Product
with MAVIG PORTEGRA 2 Correction
System (Radiation protection
system)
5/10/2012 Expert Tibial Nail PROtect Ø 8.0 Medical Recall Class II Hospital
– 13.0 mm, cannulated, length Device
255 – 465 mm, Gentamicin
Sulphate, Titanium Alloy (TAN),
dark blue, sterile, (Antibiotic
coated tibial nail)
4/10/2012 Cancellous Bone Impactor Medical Recall Class II Hospital
6.0mm, Flattened (Supplied as Device
part of the bone internal fixation
system implantation kit)
4/10/2012 Durom Acetabular Component Medical Hazard Alert Class II Hospital
(Used for metal on metal hip Device
replacements)
4/10/2012 Surecan Angled Needle (Non- Medical Recall Class II Hospital
coring needle for access ports) Device

Datei Levelvi
4/10/2012 Triathlon CR/PS Inserts & ASYM Medical Recall Class II Hospital
Patella, Brunswik Captive Device
Cemented Cup, Avon Patella
Medium & Patella Femoral Joint,
HMRS Humerus Bearing, MRH
Bumper Neutral/3 Degrees &
Tibial Inserts, Scorpio CR Tibial
Insert & Medialised Patella,
Duracon PCA Femoral, Patella &
Constrain Inserts, Scorpio PS
Tibial & Flex PS/+PS/+PCS
Inserts (total knee, hip, shoulder
components) and Artisan Bone
Plug
4/10/2012 Typhim Vi Vaccine 25ug/0.5mL Medicine Recall Class III Retail
Solution for Injection (Salmonella
typhi Vi polysaccharide)
3/10/2012 Brilliance CT Big Bore with Medical Recall for Class II Hospital
Software Versions 2.4.7 or 2.4.8 Device Product
(Full body CT system) Correction
3/10/2012 Dimension Vista IRON Flex Medical Recall for Class II Hospital
reagent cartridge. An in vitro Device Product
3/10/2012 Spring Arm (Intended for use as Medical Recall for Class I Hospital
a ceiling mounted device to Device Product
support or position equipment in Correction
the patient area)
(Used as part of a Total Device
Conventional Hip Replacement
system)
2/10/2012 HLS Cannulae (Used for the Medical Recall Class II Hospital
cannulation of suitable vessels Device
during extra corporeal circulation
as inflow or outflow cannula)
28/09/2012 Hospira LifeCare 4200 Patient- Medical Recall for Class I Hospital
Controlled Analgesia (PCA) Device Product
Infuser, PCA with MedNet Correction
Software Infusers (general
purpose infusion pump).
28/09/2012 PillCam Express Delivery Device Medical Recall Class I Hospital
(Indicated for the Device
transendoscopic delivery of the
PillCam SB video capsule in
patients who are unable to ingest
the PillCam capsule or are
known to have slow gastric
emptying time)
27/09/2012 MX 16-Slice (Full body CT Medical Recall for Class II Hospital
system) oil accumulator within Device Product
gantry Correction
27/09/2012 TempSpan CMT (Temporary Medical Recall for Class III Retail
composite dental cement) Device Product
Correction

Datei Levelvi
26/09/2012 ARCHITECT HAVAb-IgG Assay Medical Recall for Class II Hospital
(Indicated as an aid in the Device Product
diagnosis of hepatitis A viral Correction
infection or detection of IgG anti-
HAV ). An in-vitro diagnostic
medical device
26/09/2012 BD MAX (6 channel) Instruments Medical Recall for Class II Hospital
(Automated specimen Device Product
preparation and PCR Correction
amplification/detection
instrument). An in-vitro
26/09/2012 HeartStart XL Defibrillator Medical Recall for Class I Hospital
Battery / Monitor, model M3516A Device Product
(manual defibrillator). Correction
26/09/2012 IMMULITE /IMMULITE 1000 Medical Recall for Class II Hospital
Osteocalcin Control Module Device Product
(Clinical chemistry hormones). Correction
device (IVD)
26/09/2012 Spectra Optia Apheresis System Medical Recall for Class II Hospital
Device Product
Correction
25/09/2012 Osseotite NT Certain Implant Medical Recall Class II Retail
5mm x 10mm (endosseous Device
dental implant)
25/09/2012 VenoCath Drum Cartridge Medical Recall Class I Hospital
Catheter (intravascular catheter) Device
24/09/2012 Standard Cranial Reference Medical Recall Class II Hospital
Array (used with Vector Vision Device
Cranial Navigation System)
21/09/2012 Bolton Surgical - Sims Speculum Medical Recall Class II Hospital
D/E Insulated Large 33 x 38 mm Device
18.5cm
21/09/2012 Brilliance CT 6, 16, MX8000 v. Medical Recall for Class II Hospital
EXP and GEMINI Dual Oil Device Product
Accumulator within the Gantry Correction
(combination diagnostic imaging
system (PET/CT)
21/09/2012 Invacare I-Fit Shower Chair Medical Recall Class II Consumer
Device
21/09/2012 Sorin S5/C5 Perfusion System: Medical Recall for Class I Hospital
S5 Single Roller Pump 150 and Device Product
S5 Double Roller Pump 85 Correction
(Heart-lung Bypass System)
21/09/2012 Zimmer A.T.S. 3000 Automatic Medical Recall for Class II Hospital
Tourniquet System (used to Device Product
temporarily occlude blood flow Correction
during surgery)
20/09/2012 Patient Labels for Zimmer Medical Recall for Class III Hospital
orthopaedic implants Device Product
manufactured prior to March Correction
2010.

Datei Levelvi
20/09/2012 SIFROL (pramipexole HCl) Medicine Recall for Class II Retail
Tablets 0.125mg 30's, SIFROL Product
(pramipexole HCl) Tablets Correction
0.25mg 100's, SIFROL
(pramipexole HCl) Tablets 1mg
100's
20/09/2012 Soft-Core Obturators (Warm Medical Recall Class III Retail
bonded endodontic obturation Device
system obturator)
19/09/2012 Genscreen HIV Ag/Ab Ultra. An Medical Recall for Class II Hospital
(IVD) Correction
19/09/2012 Patient Specific Active Medicine Recall Class I Consumer
Medication Rolls containing
SERENACE 0.5mg Tablets
14/09/2012 Flex Large 4 Coil for Medical Recall for Class II Hospital
MAGNETOM Skyra, Verio, Device Product
Spectra and Biograph mMR (Full Correction
body MRI System)
14/09/2012 INHALO CD Cylinder (Medical Medicine Recall Class II Hospital
oxygen), Product Code: 400CD
14/09/2012 SPIRALOK Anchors (suture Medical Recall Class II Hospital
anchors used to reattach soft Device
tissue to bone in orthopaedic
surgery)
14/09/2012 Stellaris PC Vision Enhancement Medical Recall for Class II Hospital
System (Cataract Device Product
Extraction/Vitrectomy System) Correction
14/09/2012 SureSigns VSi/VS2 Patient Medical Recall for Class II Hospital
Monitors (mulitparameter patient Device Product
monitor) Correction
13/09/2012 B. Braun Infusomat Space Medical Recall for Class II Hospital
Infusion System (infusion pump) Device Product
Correction
13/09/2012 Serenace (haloperidol) 0.5mg Medicine Recall Class I Consumer
tablet bottle
12/09/2012 Arthrex and Andreas Hettich Medical Recall for Class III Hospital
Rotofix 32A Centrifuge, An in Device Product
(IVD)
12/09/2012 Immulite 2000, 2000 XPi EBV- Medical Recall for Class II Hospital
EBNA IgG Assay; An in vitro Device Product
11/09/2012 V60 Non Invasive Ventilators Medical Recall for Class I Hospital
(adult mechanical ventilator) Device Product
Correction
7/09/2012 ClearLink System BURETROL Medical Recall Class I Hospital
Solution Set with 150ml Device
ClearLink Burette (Ball-Valve
Drip Chamber) (Administration
sets for the infusion of
intravenous solutions and blood)

Datei Levelvi
7/09/2012 Eclipse Treatment Planning Medical Recall for Class II Hospital
System, (radiation therapy Device Product
treatment planning system). Correction
Versions: 8.9 and 10
7/09/2012 GH3 Lifting Hanger (patient lift) Medical Recall for Class II Retail
Device Product
Correction
6/09/2012 ADVIA Centaur BR Assay for CA Medical Recall Class II Hospital
27.29, ADVIA Centaur BR Assay Device
for CA 15-3. An in vitro
diagnostic devices (IVD)
6/09/2012 Mystic Pump with M-Style Medical Recall Class II Hospital
Mushroom Cup, Pack Size 1 Device
6/09/2012 Remel Xpect Clostridium difficile Medical Recall Class II Hospital
Toxin A/B. An vitro diagnostic Device
5/09/2012 Equinoxe Reverse Compression Medical Recall Class II Hospital
Screws, Replicator Plates, Device
Locking Screws, Compression
Screw Kit, Fracture Adapter Tray
Screws and Octane-C
Intervertebral fusion devices
(intended for Primary and
Reverse Total Shoulder joint
Arthroplasty)
5/09/2012 Multiple Topiramate Sandoz 60 Medicine Recall Class II Retail
HDPE tablet bottle, various
concentrations
5/09/2012 Octagam 10% 20g/200mL Medicine Recall Class II Hospital
Human Normal Immunoglobulin
(solution for intravenous infusion)
5/09/2012 Water Filters on Cavitron Scalers Medical Recall for Class III Retail
and Air Polishing Units Device Product
(ultrasonic peridontic scaler) Correction
4/09/2012 Brilliance 6, 10, 16, 40, 64 and Medical Recall for Class II Hospital
Brilliance CT Big Bore Systems Device Product
with a Multifunction Footswitch Correction
(Full body CT diagnostic system)
3/09/2012 DBL Irinotecan hydrochloride Medicine Recall Class II Hospital
injection vial 100mg/5ml
3/09/2012 Integra CT-compatible Intubation Medical Recall for Class II Hospital
Head Ring Assembly (HRAIM), Device Product
(used to stabilise the head during Correction
an imaging procedure)
Catalogue Number : HRAIM
3/09/2012 Mahurkar Acute Lumen Medical Recall for Class II Hospital
Catheters, labelled with Non- Device Product
DEHP Symbol. (Closed loop, Correction
haemaodialysis catheter)
3/09/2012 PREVI Isola System. An in vitro Medical Recall for Class II Hospital
Correction
3/09/2012 Timesco Laryngoscope Handle Medical Recall Class II Hospital
Contact Discs (used in intubation Device
procedures)

Datei Levelvi
31/08/2012 6.5 Cancellous Bone Screw Medical Recall Class II Hospital
35mm (Used in total hip joint Device
arthroplasty when the surgeon
elects to use a cluster/multi-hole
shell in the acetabulum
prosthetic component)
Centaur XP (Immuno-assay Device Product
analysers). An in vitro diagnostic Correction
30/08/2012 Affinity Four Birthing Bed Medical Recall for Class II Hospital
Device Product
Correction
30/08/2012 Clear Canal (ear wax removal Medical Recall Class III Retail
kit) Device
30/08/2012 Low Profile Abutment Hexed Medical Recall for Class II Hospital
Castable Cylinder, Model Device Product
LPCCC1 Correction
30/08/2012 Spacelabs Healthcare Integrated Medical Recall for Class II Hospital
Module Housing (Used for Device Product
accommodating additional Correction
modules to the patient monitor
whenever needed)
30/08/2012 Surecan Safety II (Needles with Medical Recall Class II Hospital
special bevel for implanatable Device
access ports).
29/08/2012 Sharpoint IQ Geometry Slit Medical Recall Class II Hospital
Knives (Ophthalmic surgical Device
implement intended to make
precise incisions in eye tissue)
28/08/2012 Protege EverFlex Self- Medical Recall Class II Hospital
Expanding Peripheral Stent Device
System containing all size
variants of 5mm diameter stent
in both 80cm and 120cm delivery
catheters. Protege EverFlex Self-
Expanding Peripheral Stent
System containing all size
variants of 200mm length stent in
6, 7, 8mm diameter stent in
120cm delivery catheters.
(Vascular prosthetic stent)
28/08/2012 Syntel Vascular Catheters and Medical Recall Class I Hospital
Syntel Biliary Catheters Device
(embolectomy catheter)
27/08/2012 Canon CXDA - 70C Wireless Medical Recall for Class II Hospital
Computed radiographic system Device Product
Correction
24/08/2012 BiCNU (Carmustine 100mg Medicine Recall Class I Hospital
powder vial for IV injection)
24/08/2012 Duet TRS Universal Straight and Medical Recall Class I Hospital
Articulating Single Use Loading Device
Units (Internal stapling device
used in abdominal,
gynaecologic, paediatric and
thoracic surgery for resection,
transection and creation of
anastomosis)

Datei Levelvi
23/08/2012 ACTIFUSE ABX Synthetic Bone Medical Recall for Class II Hospital
Substitute (artifical bone graft) Device Product
Correction
23/08/2012 DRX Evolution System (digital Medical Recall for Class III Hospital
Correction
23/08/2012 Intuitive Surgical Version 12 Tip Medical Recall Class II Hospital
Cover for 8mm Monopolar Device
Curved Scissors (endotherapy
scissors)
22/08/2012 GUIDELINER Intravascular Medical Recall Class II Hospital
Guiding Catheter Device
human thymocyte
immunoglobulin) 25mg Powder
for infusion vial
21/08/2012 AEZ Mini Distal Cutter w/ Hold Medical Recall Class III Retail
Short (Used to cut archwires Device
during orthodontic treatment)
21/08/2012 Armada 35 and Armada 35LL Medical Recall Class I Hospital
percutaneous transluminal Device
angioplasty (PTA) catheter
(balloon dilation catheter)
21/08/2012 CANESTEN clotrimazole thrush Medicine Recall Class III Wholesale
treatment 6 day cream 1% w/w
cream tube
21/08/2012 Clinac, Trilogy, Novalis Tx and Medical Recall for Class I Hospital
Unique linear accelerators Device Product
(Intended to provide stereotactic Correction
radiosurgery and precision
radiotherapy for lesions, tumours
and other conditions requiring
radiation therapy)
21/08/2012 Dimension Clinical Chemistry Medical Recall for Class II Hospital
System - Haemoglobin A1c Device Product
(HbA1c). An in vitro diagnostic Correction
16/08/2012 Cavitec (A dental material Medical Recall Class III Retail
indicated for use as a cavity Device
liner, eg. pulp capping.)
16/08/2012 Xia 3 Torque Wrench and Mantis Medical Recall Class II Hospital
Redux Torque Wrench (Supplied Device
as part of Xia 3 instrument tray)
14/08/2012 Digital Linear Accelerators fitted Medical Recall for Class II Hospital
with X-ray Volume Imaging (XVI) Device Product
Correction
14/08/2012 Halo Flex Energy Generators Medical Recall for Class II Hospital
(Endotherapy electrosurgical Device Product
unit) Correction
14/08/2012 Multiple Suture Anchors: Various Medical Recall Class I Hospital
models of HEALICOIL, Device
TWINFIX, BIORAPTOR,
FOOTPRINT Suture Anchors
(Used to attach the end of a
synthetic or natural ligament to
bone)

Datei Levelvi
14/08/2012 Welch Allyn KleenSpec Medical Recall for Class II Hospital
Disposable Vaginal Speculum Device Product
Correction
13/08/2012 Kidwalk Dynamic Mobility Medical Recall for Class II Consumer
System, model number: KW01 Device Product
(A wheeled support frame Correction
intended to assist a disabled
child in walking by providing a
means of support)
13/08/2012 Pentax PTX-EG-387UTK Medical Recall for Class II Hospital
Ultrasound Video Gastroscope Device Product
(flexible gastroduodenoscope) Correction
13/08/2012 Post Fuse Assembly with Power Medical Recall for Class II Consumer
Wheelchairs (electronic Device Product
wheelchair) Correction
10/08/2012 Calibrator B from ADVIA Centaur Medical Recall for Class II Hospital
FSH Assay (used with ADVIA Device Product
Centaur or ADVIA Centaur XP Correction
10/08/2012 Calibrator B from ADVIA Centaur Medical Recall for Class II Hospital
Prolactin Assay (used with Device Product
ADVIA Centaur CP System). An Correction
(IVD)
10/08/2012 Jenx Ltd Headrest Brackets (An Medical Recall for Class II Consumer
externally applied orthopaedic Device Product
frame for standing). Correction
10/08/2012 L-Gell Ultrasound Transmission Medical Recall Class II Retail
Gel – 5ltr & 250mls Device
10/08/2012 Lomb Scalpel Blade Medical Recall Class II Hospital
Device
10/08/2012 PCA Empty Sterile vials with Medical Recall for Class II Hospital
injector. (Intravenous fluid Device Product
container). Correction
10/08/2012 Vital Signs Disposable General Medical Recall Class I Hospital
Purpose 9 French Temperature Device
probes
9/08/2012 E1-Tapered 10 degree +3mm Medical Hazard Alert Class II Hospital
Liner 32/39 (hip joint prosthesis, Device
acetabular component)
9/08/2012 Eon, Eon Mini and Brio Medical Hazard Alert Class I Hospital
Implantable Pulse Generator Device
(IPG) (Implantable Spinal Cord
and Deep Brain Stimulators)
9/08/2012 NC and RC screw for Cares Medical Recall Class II Hospital
Abutment, Zr02 and IFU Device
9/08/2012 TempBond NE (temporary dental Medical Recall for Class III Retail
cement) Device Product
Correction
8/08/2012 Brilliance 64 and Ingenuity CT Medical Recall for Class I Hospital
4.0.0.xx379 (Full body diagnostic Correction
CT X-ray system)

Datei Levelvi
8/08/2012 Carescape Monitor B650 (Multi Medical Recall for Class II Hospital
parameter patient monitor) Device Product
Correction
8/08/2012 Carescape Monitor B850, all Medical Recall for Class II Hospital
software versions Device Product
(mutliparameter patient monitor) Correction
8/08/2012 Cobas IT 3000 Haematology Medical Recall for Class II Hospital
Performance Suite, keyboard Device Product
differential keyboard (with Cobas Correction
IT 3000 versions 2.03.08 to
2.04.00). An in vitro diagnostic
8/08/2012 Dash 3000/4000/5000 Patient Medical Recall for Class II Hospital
Monitor with software version 6.0 Device Product
and later (multiparameter patient Correction
monitor).
8/08/2012 DGPHP RFA High-Power single Medical Recall Class I Hospital
use grounding pads and Cool-tip Device
RFA Electrode Kits (containing
DGPHP RFA High-Power single
use grounding pads), Dispersive
electrode used during
radiofrequency lesioning
procedures)
8/08/2012 Substrate buffer used with Medical Recall for Class II Hospital
LIFECODES PAK12 and Device Product
LIFECODES PF4IgG Kits. An in Correction
(IVD)
6/08/2012 ADVIA Centaur HIV 1/O/2 Medical Recall for Class II Hospital
Enhanced (EHIV) reagent kit. An Device Product
(IVD)
6/08/2012 Agility (An integral beam limiting Medical Recall for Class I Hospital
device used with linear Device Product
accelerators) Correction
6/08/2012 Alaris LVP module (model 8100) Medical Recall for Class I Hospital
(General purpose infusion pump) Device Product
Correction
6/08/2012 Allersearch Economist Forte Medical Recall Class II Retail
Nebuliser (non heated nebuliser) Device
6/08/2012 Apex Modular Hip Stem Size Medical Recall Class II Hospital
4/11.5 (Internal joint prosthesis, Device
femoral component)
6/08/2012 ARCHITECT Toxo IgG; An in Medical Recall Class II Hospital
(IVD)
6/08/2012 Cobas 4800 BRAF V600 Medical Recall Class III Hospital
Mutation Test (acquired genetic Device
alteration IVD). An in vitro
6/08/2012 Cobas 8000 'v2' instrument Medical Recall for Class II Hospital
drivers for Cobas IT 3000 (Used Device Product
with Cobas IT 3000 versions Correction
2.03.08 to 2.04.00); An in vitro

Datei Levelvi
6/08/2012 Innova 2121IQ and Innova Medical Recall for Class II Hospital
3131IQ Cardiovascular X-Ray Device Product
Imaging Systems (diagnostic Correction
fluoroscopic angiography x-ray
system)
6/08/2012 Proximate PPH Hemorrhoidal Medical Recall Class II Hospital
Circular Stapler and Accessories Device
33mm, Product code PPH03 and
Proximate HCS Hemorrhoidal
Circular Stapler and Accessories
33mm, Product code PPH01
(Used for treatment of prolapse
and hemorrhoids)
6/08/2012 SMR L2 Metal Back Glenoid Medical Hazard Alert Class II Hospital
Component (part of the total Device
shoulder glenoid replacement)
3/08/2012 Captura Disposable Biopsy Medical Recall Class II Hospital
Forceps (endotherapy forceps, Device
flexible, single use)
3/08/2012 Eon Mini and Brio Implantable Medical Hazard Alert Class I Hospital
Pulse Generators (IPG) Device
(Implantable Spinal Cord and
Deep Brain Stimulators)
3/08/2012 Essenta DR Compact (General Medical Recall for Class II Hospital
purpose X-ray system) Device Product
Correction
2/08/2012 Access Immunoassay Systems Medical Recall Class II Hospital
Access Folate Calibrators, Part Device
numbers: A14207, A98033. An in
(IVD)
2/08/2012 Keypad of Alaris LVP module Medical Recall for Class II Hospital
(Component of a general Device Product
purpose infusion pump); Module Correction
Model: 8100
30/07/2012 ADVIA Centaur Multi-Diluent 1 Medical Recall Class II Hospital
supplied with ADVIA Centaur Device
BNP kit and ADVIA Centaur
TSH-3 Ultra kit; An in vitro
27/07/2012 Afinion AS100 Analyser, CRP Medical Recall for Class II Hospital
and CRP Control; An in vitro Device Product
27/07/2012 Extrude Wash (Dental Medical Recall for Class III Retail
impression material) Device Product
Correction
27/07/2012 Onyx Liquid Embolic System Medical Recall for Class I Hospital
(LES), (Used for embolization of Device Product
intracranial aneurysms and Correction
lesions in the peripheral and
neurovasculature).
27/07/2012 syngo Dynamics (Radiology Medical Recall for Class II Hospital
picture archiving and Device Product
communication system); Version Correction
9.5

Datei Levelvi
27/07/2012 syngo Imaging XS (Radiology Medical Recall for Class II Hospital
picture archiving and Device Product
communication system). Version Correction
VA70A or higher
27/07/2012 syngo Plaza (Radiology picture Medical Recall for Class II Hospital
archiving and communication Device Product
system) Correction
26/07/2012 GemStar Docking Station (Used Medical Recall Class I Hospital
as an alternate power source for Device
the GemStar pump and to
charge a GemStar battery pack)
26/07/2012 HemoCue Glucose 201 RT and Medical Recall Class I Hospital
201 DM RT Systems. A point of Device
care in vitro diagnostic medical
device (IVD).
24/07/2012 SAIZEN somatropin (rmc) Medicine Recall Class II Consumer
solution for injection multidose
cartridge
20/07/2012 44R82 Tube Clamp Adapter Medical Recall for Class II Retail
(Prosthetic component part) Device Product
Correction
20/07/2012 AEZ Mini Distal Cutters w/ Hold Medical Recall Class III Retail
Long (Used to cut archwires Device
during orthodontic treatment)
20/07/2012 Animas Insulin Infusion Pump Medical Recall Class I Consumer
(ambulatory insulin infusion Device
pump), models - IR 2020, 1200
20/07/2012 Birdie, Birdie Compact and Medical Recall for Class II Consumer
Flamingo Lifters (Patient Lifters) Device Product
Correction
19/07/2012 4.5mm Dyonics Bonecutter Medical Recall Class II Hospital
Electroblade (used during Device
arthroscopic procedures for
simultaneous soft and osseous
tissue resection using
mechanical action and
coagulation via RF energy)
19/07/2012 Brilliance series 6, 16, 40, 64, CT Medical Recall for Class II Hospital
Big Bore, iCT and iCT SP (CT Device Product
systems) Correction
19/07/2012 CSL Rh(D) IMMUNOGLOBULIN Medicine Recall Class II Sponsor
VF (human) 250 IU injection vial
19/07/2012 Discovery Tray - Child and Small Medical Recall Class III Retail
Sizes (A disposable foam tray Device
used for topical oral fluoride
applications)
19/07/2012 Philips HeartStart MRx cardiac Medical Recall for Class II Hospital
monitor / defibrillator, model Device Product
number: M3536A with R.03.03 Correction
software and 12 Lead option
(manual defibrillator)
19/07/2012 Philips HeartStart MRx cardiac Medical Recall for Class I Hospital
monitor / defibrillator, model Device Product
numbers: M3535A, M3536A, Correction
M3536M4, M3536M5, and
M3536M6 (manual defibrillator)

Datei Levelvi
19/07/2012 Philips HeartStart MRx cardiac Medical Recall for Class I Hospital
monitor / defibrillators, Device Product
models:M3535A, M3536A, Correction
M3536J, M3536M, M3536MC,
M3536M1, M3536M2, M3536M3,
M3536M4, M3536M5 and
M3536M6 (manual defibrillator)
19/07/2012 Shiley Reusable Cannula Cuffed Medical Recall Class I Hospital
Tracheostomy Tubes, Product Device
codes: 8FEN, 8LPC, 8LPC-S
19/07/2012 Sysmex CS-2100i/2000i Medical Recall for Class II Hospital
Systems (Coagulation Device Product
Analysers), Software Versions: Correction
up to and incl. SW 00-60 (CS-
2x00i). An in vitro diagnostic
16/07/2012 GENTECH molybdenum (99Mo) Medicine Recall Class II Hospital
/ technetium (99mTc) sterile
generator for production of
sodium pertechnetate (99mTc)
injection multi dose vial (Used to
produce metastable
isotope99mTc from a decaying
Molybdenum-99 bound onto a
generator column)
13/07/2012 Bowl Surgical Drape Medical Recall Class II Hospital
Device
13/07/2012 Leukine sargramostim (Liquid Medicine Recall Class II Hospital
Injection) 500mcg/mL vial
13/07/2012 Mirage, Silverspeed, X-celerator Medical Recall Class II Hospital
& X-pedion Guidewires, Device
Hyperform & Hyperglide
Occlusion Balloon Catheters and
Guidewires (Supplied in
Procedure Packs)
12/07/2012 Alaris PC Unit (General purpose Medical Recall for Class I Hospital
infusion pump) Device Product
Correction
12/07/2012 CT1133S Cephalexin 100ug Medical Recall Class II Hospital
CL100 Antimicrobial Device
Susceptibility Discs (Used for
antimicrobial susceptibility
testing), An in vitro diagnostic
12/07/2012 Dimension RxL Reagent Medical Recall for Class II Hospital
Management System (RMS) Device Product
Power Cord Plug; An in vitro Correction
12/07/2012 Portapres NiMh battery pack Medical Recall Class II Hospital
(Device to continuously measure Device
blood pressure)
12/07/2012 Premier C. difficile GDH - Medical Recall for Class III Hospital
Positive Control Lot 6088.011, Device Product
(Enzyme Immunoassay kit for Correction
the detection of C. difficile
antigen (GDH)); An in vitro

Datei Levelvi
11/07/2012 AcrySof CACHET Phakic Lens Medical Hazard Alert Class II Hospital
(Intraocular lens used for the Device
reduction or elimination of
myopia)
11/07/2012 STERRAD 100S System Medical Recall Class II Hospital
Cassettes (To provide the Device
hydrogen peroxide sterilant used
in the STERRAD Steriliser)
11/07/2012 ULTRA Fabric Reinforced Medical Recall Class II Hospital
Surgical Gown, X- Large; Device
MICROCOOL Breathable Gown,
with SECURE-FIT, with Towel,
X-Large
6/07/2012 ABGII Modular Stems and ABGII Medical Hazard Alert Class II Hospital
Modular Necks (An Device
exchangeable modular neck,
designed to allow intra-operative
flexibility for bio mechanical
adjustment of offset and
anteversion without affecting leg
length)
5/07/2012 Alginot (dental impression Medical Recall for Class III Retail
material); All product lots within Device Product
shelf life Correction
5/07/2012 Elekta Monaco rel. 3.10.00 Medical Recall for Class II Hospital
through 3.20.00 & Focal rel. Device Product
4.64.00 through 4.70.00 Correction
(Radiation Therapy Treatment
Planning System)
5/07/2012 Indirect (Closed-Tray) Transfer Medical Recall Class III Retail
for Internal Hexagon (Used to Device
create the necessary dental
suprastructure preparation
during the healing and
sculpturing period of the soft
tissue)
5/07/2012 STERRAD CYCLESURE 24 Medical Recall Class II Hospital
Biological Indicators within Device
Validation Kits - Product codes:
14324, 20253, 20228, 20232
(sterilisation process indicator)
5/07/2012 Twinfix Ultra Ti Suture Anchor, Medical Recall Class II Hospital
5.5mm (used to attach the end or Device
ends of a synthetic or natural
ligament to bone)
3/07/2012 Matrix Surgical Laparoscopic Medical Recall Class II Hospital
Spatula with cable (active Device
endotherapy device).
2/07/2012 Eclipse Treatment Planning Medical Recall Class II Hospital
System (Radiation treatment Device
planning system); Version 8.5,
8.6, 8.9, 10 & 11
2/07/2012 Laryngoscope Handles (LED) Medical Recall for Class II Hospital
(Item No 08-100) and Device Product
Laryngoscope Fibre Optic Correction
Blades (Item No 08-101)

Datei Levelvi
2/07/2012 SEBIFIN terbinafine (as Medicine Recall Class II Retail
hydrochloride) 250 mg tablet,
blister packs of 42 tablets
DGXN Slides; An in vitro Device Product
Footnotes
i Recall Action Commencement Date: The date the recall strategy and communication was agreed by the TGA.
ii Product Name/Description: Brand name (including active ingredient for medicines), and may include generic
reference for the kind of medical devices.
iii Type of Product: Medicine (including vaccines), Medical Device, or Biological.
iv Recall Action**: A Recall action is an action taken to resolve a problem with a therapeutic good already supplied in
the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or
presentation. There are four distinct recall actions – recall, product defect correction, hazard alert and product defect
alert:
• Recall - The permanent removal of an affected therapeutic good from supply or use in the market.
• Product defect correction - Repair, modification, adjustment or re-labelling of a therapeutic good. The
corrective action may take place at the user's premises or any other agreed location.
• Hazard alert - Information issued to healthcare professionals about issues or deficiencies relating to an
implanted medical device or biological product and advice about the ongoing management of patients.
• Product defect alert - Information issued to raise awareness about issues or deficiencies for a therapeutic
good where a recall action will result in interruption of patient treatment or a medicine shortage, including advice
to reduce potential risks of using affected goods.
v Recall Action Classification**: Recall actions of therapeutic goods are classified based on the potential risk the
deficiency poses to patients / consumers. They are classified as Class I, Class II or Class III.
• Class I - A situation in which there is a reasonable probability that the use of, or exposure to, the deficient
therapeutic good(s) will cause serious adverse health consequences or death.
• Class II - A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or
medically reversible adverse health consequences, or where the probability of serious adverse health
consequences is remote.
• Class III - A situation in which use of, or exposure to, the deficient therapeutic good(s) is not likely to cause
adverse health consequences.
vi Recall Action Level: The depth to which the recall action is to be undertaken. This is based on the assessment of the
risk to public health and safety, acknowledging the channels through which the goods have been supplied. The recall
action levels are given below and are cumulative, e.g. Retail Level, includes Hospital and Wholesale:
• Wholesale - includes wholesalers and state purchasing authorities.
• Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue
banks and laboratories as well as wholesale as appropriate.
• Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale
and hospital as appropriate.
• Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate.

** These definitions are applicable to the 2017 URPTG (Implemented from Jan 15 2018). Recall Action types and
Recall Action Classifications prior to 15 Jan 2018 can be found at https://www.tga.gov.au/sites/default/files/recalls-
urptg-170412.pdf


Arn Report List 20200505

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Arn Report List 20200505

Uploaded by

Copyright:

Available Formats

Recall Action Result Summary

You searched for recall action reports between 01/07/2012 – 03/05/2020:

© Commonwealth of Australia 2020.

Important information on the System for Australian Recall Actions

About the release of this information

Report generated 5/05/2020 9:36:56 PM Page 2 of 305

Recall Action Details

Report generated 5/05/2020 9:36:56 PM Page 3 of 305

Report generated 5/05/2020 9:36:56 PM Page 4 of 305

Report generated 5/05/2020 9:36:56 PM Page 5 of 305

Report generated 5/05/2020 9:36:56 PM Page 6 of 305

Report generated 5/05/2020 9:36:56 PM Page 7 of 305

Report generated 5/05/2020 9:36:56 PM Page 8 of 305

Report generated 5/05/2020 9:36:56 PM Page 9 of 305

Report generated 5/05/2020 9:36:56 PM Page 10 of 305

Report generated 5/05/2020 9:36:56 PM Page 11 of 305

Report generated 5/05/2020 9:36:56 PM Page 12 of 305

Report generated 5/05/2020 9:36:56 PM Page 13 of 305

Report generated 5/05/2020 9:36:56 PM Page 14 of 305

Report generated 5/05/2020 9:36:56 PM Page 15 of 305

Report generated 5/05/2020 9:36:56 PM Page 16 of 305

Report generated 5/05/2020 9:36:56 PM Page 17 of 305

Report generated 5/05/2020 9:36:56 PM Page 18 of 305

Report generated 5/05/2020 9:36:56 PM Page 19 of 305

Report generated 5/05/2020 9:36:56 PM Page 20 of 305

Report generated 5/05/2020 9:36:56 PM Page 21 of 305

Report generated 5/05/2020 9:36:56 PM Page 22 of 305

Report generated 5/05/2020 9:36:56 PM Page 23 of 305

Report generated 5/05/2020 9:36:56 PM Page 24 of 305

Report generated 5/05/2020 9:36:56 PM Page 25 of 305

Report generated 5/05/2020 9:36:56 PM Page 26 of 305

Report generated 5/05/2020 9:36:56 PM Page 27 of 305

Report generated 5/05/2020 9:36:56 PM Page 28 of 305

Report generated 5/05/2020 9:36:56 PM Page 29 of 305

Report generated 5/05/2020 9:36:56 PM Page 30 of 305

Report generated 5/05/2020 9:36:56 PM Page 31 of 305

Report generated 5/05/2020 9:36:56 PM Page 32 of 305

Report generated 5/05/2020 9:36:56 PM Page 33 of 305

Report generated 5/05/2020 9:36:56 PM Page 34 of 305

Report generated 5/05/2020 9:36:56 PM Page 35 of 305

Report generated 5/05/2020 9:36:56 PM Page 36 of 305

Report generated 5/05/2020 9:36:56 PM Page 37 of 305

Report generated 5/05/2020 9:36:56 PM Page 38 of 305

Report generated 5/05/2020 9:36:56 PM Page 39 of 305

Report generated 5/05/2020 9:36:56 PM Page 40 of 305

Report generated 5/05/2020 9:36:56 PM Page 41 of 305

Report generated 5/05/2020 9:36:56 PM Page 42 of 305

Report generated 5/05/2020 9:36:56 PM Page 43 of 305

Report generated 5/05/2020 9:36:56 PM Page 44 of 305

Report generated 5/05/2020 9:36:56 PM Page 45 of 305

Report generated 5/05/2020 9:36:56 PM Page 46 of 305

Report generated 5/05/2020 9:36:56 PM Page 47 of 305

Report generated 5/05/2020 9:36:56 PM Page 48 of 305

Report generated 5/05/2020 9:36:56 PM Page 49 of 305

Report generated 5/05/2020 9:36:56 PM Page 50 of 305

Report generated 5/05/2020 9:36:56 PM Page 51 of 305

Report generated 5/05/2020 9:36:56 PM Page 52 of 305

Report generated 5/05/2020 9:36:56 PM Page 53 of 305

Report generated 5/05/2020 9:36:56 PM Page 54 of 305

Report generated 5/05/2020 9:36:56 PM Page 55 of 305

Report generated 5/05/2020 9:36:56 PM Page 56 of 305

Report generated 5/05/2020 9:36:56 PM Page 57 of 305

Report generated 5/05/2020 9:36:56 PM Page 58 of 305

Report generated 5/05/2020 9:36:56 PM Page 59 of 305