Professional Documents
Culture Documents
FMI TYPE
☐Recall/Reportable
☐Business FMI – Mandatory
☒Business FMI - On Request
☒ Customer list is provided. If you identify additional units within effectivity range, but they are not
shown on customer list, contact the FMI Administrator.
☐ No customer list is provided. Each service location must identify affected units and place orders as
indicated in the special instructions section.
☒ Kit/Part(s) are required, contact you FMI Administrator.
RESOURCE PLANNING (Est.): One Field Engineer for 1 hour at field plus 1 hour travel time
TECHNICAL SUPPORT
APAC CHINA EAGM EUROPE
Please contact a support Please contact with Region GEMS- OLC EAGM GEMS – OLC EUROPE
engineer in your region. Support Engineer (RSE) in your Levent Ofis – Esentepe Mh, BP34 78533 BUC
region. Harman Sk. No :8 34394 CEDEX, FRANCE Tel: 33
Istanbul , Turkey (1) 30 83 13 00 Fax: 33
+90 212 398 0723 CT OLE (1) 30 70 99 70
Levent Barin
+971 50 1897074 CT OLE
Abdul Hannan
Field Modification
has been completed Field Modification has been completed on given serial In detail, state FMI was installed in accordance
1 Completed
on a given serial number. with FMI Instructions.
number.
Field Modification not required for one or more of the Provide specific scenario why the FMI is not
following: applicable to the given unit or provide
1. Original consignee list was incorrect. Current documentation from consignee indicating
unit/system configuration or type is not affected by disposition of the unit.
field action.
2. Other field action (i.e. later version SW) was
Field Modification
2 Not Required
not required.
previously installed, invalidating the field action
being tracked (i.e. earlier version SW).
3. Affected unit/system/equipment altered by
customer, field action no longer applies.
4. Affected unit/system/equipment scrapped or
destroyed.
Consignee/Customer or Field Engineer cannot find Document and archive communication and
device. actions taken to locate the unit. (See
Refusal/Location Unknown document)
Location The location of the
5 Unknown unit is unknown.
Documented attempts must be made to locate the
medical device.
City/State/Country:__________________________________________________________________
Country Code: _____________
Comments:_________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
________________________________________________________
Enter required data into Service System and/or attach documentation into Service System, if feasible and/or send to local FMI Administrator
System ID or Device Serial Number and description of Medical Device(s) transferred or sold to
Consignee/Customer:
We, < >, have elected to postpone the updates required by the Medical Device
Correction referenced above because one of the following conditions exist (Check that which applies).
Device has been deinstalled and a return to service date is unknown at this time
Device cannot be taken out of service at this time, future availability is not known
Device has been damaged or modified, such that the updates cannot be made. The schedule for
repairs to the device is not known.
OTHER:_________________________________________________________________
Disposition of associated Medical Device Correction Kit. (Check that which applies).
We, < >, understand the purpose of the correction and associated risk, and
will notify GEHC when the device is available for updates, or when the updates have been completed.
Please provide the signature of an individual with responsibility for risk and compliance.
Signature: _____________________________________________
Title: __________________________________________________
Enter required data into Service System and/or attach documentation into Service System, if feasible and/or send to local FMI Administrator
GE Healthcare
Copyright 2015 by GE Company Inc. All Rights Reserved. Page 4 of 20
Doc# < DOC1777601> Rev. <1> FMI < 22843>
FMI FIELD MODIFICATION INSTRUCTION FMI
GE Healthcare
GE Hangwei Medical Systems
2 Yongchang North Road
Beijing China
System ID or Device Serial Number and description of Medical Device(s) transferred or sold to
Consignee/Customer:
We, < >, have elected not to accept the updates required by the Medical
Device Correction referenced above.
Please provide the signature of an individual with responsibility for risk and compliance .
Signature: ________________________________________________________________
Title: _____________________________________________________________________
Address: _________________________________________________________________
City/State/Country: ________________________________________________________
Enter required data into Service System and/or attach documentation into Service System, if feasible and/or send to local FMI Administrator
Attempt 1
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name:________________________________________________________________________________
Contact’s Title/Position:__________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response:_______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone)________________________________________________________
***NOTE: 2nd and 3rd attempts may be more appropriately made by the FMI program team. ***
Attempt 2
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name:________________________________________________________________________________
Contact’s Title/Position:__________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response:_______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone)________________________________________________________
Attempt 3
Device Name and Serial/ID Number: ______________________________________________________________
Name of the person making the contact (SSO# if applicable): _________________________________________
Date of the Contact (dd/mmm/yyyy): ______________________________________________________________
Contact’s Name:________________________________________________________________________________
Contact’s Title/Position:__________________________________________________________________________
Contact's Facility Name: _________________________________________________________________________
Response:_______________________ ______________________________________________________________
Contact Method (i.e.; email address, phone)________________________________________________________
Enter required data (For each attempt) into Service System and/or attach documentation into Service System, if feasible or send to local FMI Administrator
The following Gantry model numbers are affected by this field action:
Model or Part
Description Date* / SN Range
#
5405619 Brivo CT385 Gantry for Hino MFG date from 2012/04/17 to 2015/01/18
5402412 Brivo CT385 Gantry for GEHW MFG date from 2012/05/21 to 2014/12/10
5402412-100 Brivo CT385 Gantry for SKD MFG date from 2014/10/15 to 2015/10/29
PURPOSE (DETAILED):
The purpose of FMI22843 is to deliver service pack 2.5 to Brivo CT385 running with SW v/r
11BW49.17 to fix known issues:
The detail fixes in Service packs SP2.5 and previous Service pack release can refer to Appendix B.
RELATED FMI’S:
N/A
1. Functionality Test
The SP2.5 CD provided in the FMI kits includes SP1.3, SP2.0, SP2.1, SP2.2, SP2.3,
SP2.4 and SP2.5. So other CDs existing at the customer sites are not needed after
NOTE:
installing SP2.5 CD.
2.1 The operator console front cover will need to be removed to gain access to the host
computer DVD Drive.
2.2 Open a Unix Shell.
2.3 If application software is up, type:
{ctuser@hostname}# cleanMon <enter>.
2.4 After App shutdown, in the Unix shell, type the command:
{ctuser@hostname}# swhwinfo.
2.5 Confirm SW 11BW49.17 was installed in the site.
- If the site SW version is not 11BW49.17, stop and close this FMI as a code 2. This Site is
not affected by this field action.
- If the site is running with 11BW49.17. Continue the following steps.
2.6 Insert the Service Pack 2.5 CD into DVD drive.
There are seven files in the SP2.5 CD (includes SP1.3, SP2.0, SP2.1, SP2.2, SP2.3, SP2.4 and
SP2.5).
2.7 In the Unix shell, type the command below to become root:
{ctuser@hotname} su –
And enter root password
2.8 Type command to install the Service Pack and then reboot system:
{root@hostname}# patch_install -c
The Flash Download takes 5-30 minutes, depending on which subsystems need
NOTE:
firmware updating.
3. Functionality Test
Brivo CT385
Bug Fixes in 11BW49.17 SP1.3 release
1 HCSDM00136011 [tigre]scan aborted when performing scan protocol with auto voice
2 HCSDM00135327 scan analysis z-ratio issue(tracking blocked channel)
3 HCSDM00136048 [Tigre] DT Abort could not be combined togeter.
4 HCSDM00137048 update the filament protocol.
5 HCSDM00137041 Tigre KV/MA pipeline delay
6 HCSDM00135881 [Tigre]TGP update for heater/blower failure error report.
7 HCSDM00136015 Update spec for tigre HHS
8 HCSDM00135876 Tigre: Heater and Blower error tip on Host.
9 HCSDM00136306 CT# for 16x1.25 slice thickness need to be improved
10 HCSDM00136038 [Tigre]GSPS object cannot be reviewed in imagework desktop
[Tigre]Service protocols 50.3 should use Head SFOV instead of Small
11 HCSDM00137054
SFOV
12 HCSDM00138154 [Tigre] Operation panel alignment can't work
13 HCSDM00137980 [Tigre] Reformat IQ of full mode is not as good as KL
14 HCSDM00138284 [Tigre]DT total offset after pause/resume is wrong
15 HCSDM00140334 Cradle auto-move issue we found recently
16 HCSDM00140396 Add DCB loopback function
17 HCSDM00140436 Solving Alpha error by updating IFB FPGA
18 HCSDM00147251 [Tigre] mylar windows check failed
Change 1x image spec for 35 PP phantom uniformity test and cold
19 HCSDM00142252
12.5 water scan condition
20 HCSDM00142752 [Tigre]To clear "table touch sensor error" need long time.
21 HCSDM00140432 [Tigre]protocols need to update
22 HCSDM00141537 [Tigre]Biopsy Attention shows ASiR level wordings w/o ASiR installed
23 HCSDM00143470 Wrong Japanese translation
24 HCSDM00145229 [Tigre] saveState does not work
[Tigre]New requirement to add table extender. Firmware need
25 HCSDM00142751
update.
Can not scan with "Not enough image space exists. Please remove
26 HCSDM00145915
images" message
Copyright 2015 by GE Company Inc. All Rights Reserved. Page 13 of 20
Doc# < DOC1777601> Rev. <1> FMI < 22843>
FMI FIELD MODIFICATION INSTRUCTION FMI
[Tigre]An attention popup is needed as DT makes PMR off
27 HCSDM00143570
automatically
28 HCSDM00142976 [Tigre] FRDM failed to show module alignment result
Nominal Total Collimation Width in Dose SR is not correct for Helical
29 HCSDM00140451
- Spiral Acquisition.
[Tigre] Manual Film Composer - Double click on a series makes all
30 HCSDM00146718
images in the composer on Exam Rx
31 HCSDM00143815 [Tigre] SW display wrong information about DAS&DET auxiliary data
32 HCSDM00145540 [Tigre]AutomA gives higher mA than CJ with same scan technique
33 HCSDM00142697 [Tigre]IFB power spec is incorrect
34 HCSDM00142560 bjcl-[RT]The negative mA value show in mA table.
35 HCSDM00146670 [Tigre]Trim table invalid
36 HCSDM00143452 [Tigre]IFB intermittent bad data issue
[Tigre]Cross Reference lines are not filmed on Manual Film
37 HCSDM00142978
Composer
When do Helical multi recon , and enable R2/R3 ... AutoFilm, scanRx
38 HCSDM00141633
crash when repeat this series.
39 HCSDM00143151 [Tigre] Channel map is wrong for map between IFB and module
40 HCSDM00143153 [Tigre] Retrorecon failed on DT and caused to recon shutdown
41 HCSDM00145153 No display to indicate energy saving mode
42 HCSDM00142802 [Tigre] Drift check errors in system logs during Fast Calibration
43 HCSDM00141521 [Tigre] Japanese characters are garbled on Auto Exam Description
Tigre [Cloned from TW 8344507 Cj2.0]: Paging key can not use in
44 HCSDM00141782
graphic retro for Optima660
45 HCSDM00144941 Scan abort after press start scan button for 4s
[Tigre]magenta lines and scan range line are not matched on
46 HCSDM00141518
BiopsyRx mode
47 HCSDM00147194 Add the additional mode for patch install funciton
PR 5590914 BSD Meri: On trying to film 5x5 format in DMPR it is
48 HCSDM00143468
defaulting to a 3x3 layout on the printer
49 HCSDM00148680 [Tigre]Dark bands on Head Digital Images
[Tigre] Manual Film Composer - selected layout not remembered
50 HCSDM00146723
after reboot
Bug Fixes in 11BW49.17 SP2.0 release
The spec for 35pp phantom should change to 6.0.
The scan condition for cold 12.5 water scan for 1.25x16i mode
1 HCSDM00142252
should be changed from 2.0s to 4.0s to keep consistent with hot
scan.