Urgent Field Action Notice for the Cryostat Devices ‘tention: Lab Manager, Crostat Users Marehr2019 Dear tad, Leica Biosystems Is issuing this Field Acton Notice (FAN) to inform you about a Field Action Involving the cryostat. You have received this notifcation as our records inlcate that you have ‘eceved one or more of he instuments conosrmed Affected devices: {Leica Cu1960:"" All devices with sail number 8092; 6091; 8080 to 8087; 8081; 8078; ‘8077; 8073; 8071 to 8067; 8064 to 8062: 8058 to 8053; 8051 to B04; £047; ‘8043 8040; 8038 to 8033; 8031 to 8026; 8023 to 8004; 8002 o 7040; "793607892: 7890 to 7489; 7405; and al vices wih serialnumber lower than 7486 Lelea CMI860/UV: All devices with serial number: 4201; 4200; 4196; 4189; 4192; 4188; 4188 to 4tb4; 4180; 4170, 4173 to 4170; 4168; 4188 o 4180; 4188; 4157; 4184 fo 4182; 4149, 4147; 4145 to 4135, 4193 to 4082; 4080; ‘and al dviess with serial number lower than 4090 Leica CM1820: All devices with sail umber: 1450; 1448; 1446 to 1444; 1442; 1430; “437, and all devices with serl number lower than 1437 Leica C§3050°S: All devices with seat number: 7398; 7396 to 7304; 7992; 7398 to 7387; "730507381; 7378, ad all doves wth serial number lower than 7379 Leica CwN@50UV: 2622 anda devas with sail number lowoc han 2622 Leica C1860: 7206 anda devies with serial number ower han 7265 Lelea Cw1610'S: 6600 anda dvies with soil number lower than 6800 Leica CM1100; 1418 and al devices wth serial umber lower than 1418 To eae eh 8 Fe) AE Rae ep BLaeptmcom se Boon eb Gna Hosenoge Sine 748 25 aso: Ragemap eam Re 205 ‘esouasine ash: er Rae on StataPage 218 Description ofthe problem: ‘As part of cur post market surveillance, we recogolzad that some customers are using famable ‘reezing spraye within the eyostat chamber, Al flammable freezing sprays can potential Ignite ‘and therefor can cause sarious injuries. Tho rik should be indicated on the labeling of these ‘sprays. The curentcryost: aboling, however, doesnot include any specie waring about usage ‘of lammable freezing spray. AS part of ths Field Action we ae going to Improve the labeling on the affected devices. ‘Advice on immediate actions to be taken: ‘As an immediate action, we ask you to Improve the labeling with the attached adhesve label 6s ‘shown below ‘on the devices, as well as acing a supplemental sheet to the curent Instruction for Use (FU). 4.Anpllaton ofthe adhesive abel First clean the surface sround the area where the adhesive label shall be paced (grease free) “Thon remove the provided adhesive label rom the fl and pace fon the surface as ehown inthe Pictures below. Positioning Symbol Davies ,Flammable freezing sprays prohibited" ‘Leica C1960 | 2) | | 68! a | aalmaaldadal a la Symbol anmble testo ses y s Toes ex tae Fe 0213, Re epee com nop Mash Gnah Henge Sine 7495 asc: Regge Maa 2505 ‘schtabie ais hao oar Rae| on Semana aeolen CMTB60UV Tica GHT207 Colea GM 1860 Teiea CM9060 5 SymetFarsmabig Pte /haseg snap ro ®. Tela OMT880 UV eat pp AAA Mang CHL Benne Toes peza 10 2t- Fve 2H TSE be GopBscaBrenens con eben ls nh: Henge Sab 18 8 Nach Rep ann SE ‘hehe Ago Par Ramat al eranPage 418 ‘Symbol Pammable F soa sas oie” ]elea cutaso———] Teica OMTST0S ir moe |’ Symbol Hommable oon mene | eica CmtT00 ‘Symbol "Flammable 7 Seog sprays proiited” ‘Ada te eaalyarnonament a atachod to th Fold Acton Not, tothe Cryostat inetruton for Use. “Toba 6 -F es 0) ta Rte SaptePage sie ‘Your prompt assistance to ylace the provided adhesive label nearby the erystat chamber ofthe instrument and to ad the seety amendment inthe IFU Is appreciated and necessary to prevent @ possible serous adverse event ‘Transmission of this Feld Action Noti “This Field Action Notte nesds to be passed onto all those who need to be aware within your cxganisation o to any organisation whore the affected device have been transferred. tease meiniain awareness ofthis Field Action Notice and resulting action to ensure effectiveness, ofthe corrective action. Contact reference person: {Should you have any questions, please contact Robert Gropp Lica Biosystems Nussloch GmbH Heidelberger St. 17-19 (69226 Nussloch- Garmany Tel: 00497 (6224 149 348 robert gropp@leicabiosystons.com Please sign the enclosed Fld Action Notice Return Response Form to confem that you have received and understood ths Feld Acton Note, \We are sincerely sory fr any inconvenience caused by this issue, Best ne Ebr a RAGA Manager Lelea Biosystems Nussloch GmbH ‘tne ndersion cnt ta to FAN is being made wih he kaowedpe of th elvan an Autres) abt opp ACA CHL Bans vse Thasaze nase (962416. epee com ‘ie eeynees skh GH ee a 179,625 Nau Aaa Mn i ES ‘Stacantoe a qe ln Cat Somtry LesBan cmPage 66 FIELD ACTION NOTICE RETURN RESPONSE FORM lease recrd the serial numbers) of your devica(): (Itean be found on the ideation plato on the rear ste) Lotea cto Leica comta600V sion ene20| ieica cma, ‘een cwi960__— Ca ct 60 sien cwre50uv_—_Leica cmisi0. ‘etea Gwai00. Please acknowledge by checking the boxes below. {have read end understood the Field Action Notice. Ihave paced the provided label near the cryostat chamber as mentioned in the “Advlos on inmediat action tobe taken" Ihave adie he safety amendment provided tothe IFU as mentioned inthe “Advice on inmediate action tobe taken” Ciyistate: Signature: Pease complete and return the Feld Action Notice Retum Response Form within § days after receipt o your local Leica contact person Contact Actress and ax uber / eal mus be entered bythe Reglonal SU Managors themselves abet gy RAR ng CHE Lae Donne wa ‘Team et 4 (3024 SUS, ete eae sex pa an Gn Hoonone Sine 170205 ml Rogge ram HR 8 ‘eve Mo Aq: rR Cot unt oan in