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U.S. Department of Health and Human Services

Class 2 Device Recall GSI Viewer

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 Class 2 Recall
GSI Viewer
see related information
Date Posted March 06, 2014
Recall Status1 Terminated on March 13, 2014
Recall Number Z-1148-2014
Recall Event ID 66119
Premarket Notification
510(K) Number
K081105 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare 3 (AW4.4). Computed Tomography X-Ray system
Code Information Mfg Lot or Serial # 00000218194GE9 00000175340GE9 00000208598GE3 00000187433GE8 00000187429GE6 00000173818GE6 00000186994GE0 00000187437GE9 00000186992GE4 00000187432GE0 00000172803GE9 00000213684GE4 00000169498GE3 00000172802GE1 00000171126GE6 00000213683GE6 00000171114GE2 00000171115GE9 00000171507GE7 00000171940GE0 00000171508GE5 00000171116GE7 00000171642GE2 00000171509GE3 00000171510GE1 00000171117GE5 00000175341GE7 00000180599GE3 00000218195GE6 00000212000GE4 00000207770GE9 00000171128GE2 00000175338GE3 00000194707GE6 00000180600GE9 00000207771GE7 00000171119GE1 00000180601GE7 00000171506GE9 00000172678GE5 00000171941GE8 00000171123GE3 00000171122GE5 00000171125GE8 00000186993GE2 00000171121GE7 00000171120GE9 00000186991GE6 00000186695GE7 00000171129GE0 00000207772GE5 00000211999GE8 00000194705GE0 00000175339GE1 00000171944GE2 00000198439GE2 00000187430GE4 00000183133HP8 00000171643GE0 00000L10106002 00000N10127001 00000V10334001 000000Z9309005 000000Z9309002 00000F10090001 00000H10153001 00000K10130001 000000G9337003 000000G9337002 00000W10230001 00000W10230002 00000H11083001 00000Y10245001 00000G10161002 00000M10162001 000000G9337001 00000180602GE5 00000187436GE1 00000171943GE4 00000194704GE3 00000194703GE5 00000194702GE7 00000175342GE5 00000187435GE3 00000172680GE1 00000171127GE4 00002UAO430KJL 00002UA04307KD 0000CZC9450FKS 0000CZC944B57J 0000CZC9385MCH 0000CZC94602P9 0000CZC94583RB 0000CZC1128HGN 0000CZC1128HGR 0000CZC1100YF8 0000CZC1128HGJ 00002UA04307L2 00002UA0430KL4 00002UA04307KV 00002UA04211JK 00002UA04307K5 0000CZC942647P 0000CZC9441VF1 00000V10245007 00000D10252002 0000CZC94602PY 0000CZC94602PC 00000185759HP8 0000CZC9406S71 0000CZC9412L3G 00000185734HP1 00000018579HP0 0000AB10235005 0000CZC9445HLZ 0000CZC9425PPQ 00000E10011004 00000E10011005 00000S11019009 00000S11019010 00000H11027003 00000Q11060006 000000G9337004 0000AB10126002 00000T10123004 00000E10336009 00000E10336005 00000E10336006 00000E10336008 00000E10011001 00000E10011002 00000T10123002 00000T10123001 00000H10028003 00000J10208004 00000M10189002 00000M10189003 00000F10229001 000000G9337012 00000S11019008 00000S11019007 00000N10337001 000000G9337015 000000G9337020 00000T10071001 00000ZA9324001 000000L9343005 00000E10336001 00000E10336002 00000S11019005 00000N10337005 00000N10337006 00000N10337015 00000N10337016 00000N10337017 00000S11019004 00000S11019006 00000S11019003 00000R11020006 00000R11020004 00000R11020003 00000C10256001 00000C10256002 00000C10256003 00000S11019001 000000G9337013 00000M10146001 000000L9343004 00000U10258003 00000U10259002 00000L10286003 00000U10258002 00000N10337008 00000N10337009 00000N10337010 00000Q11075001 0000CZC7435R7N 0000CZC743632K 00000V10334002 00000V10334003 000000G9337008 00000J10215003 00000J10215002 000000G9337017 00000H10131002 000000G9337018 00000G10161001 000000Z9356001 00000W10125001 00000T10109001 00000H10028002 00000L10106001 00000W10250001 000000M9322001 00000N10337007 00000A10194001 000000G9337009 000000G9337010 0000AD10244001 0000CZC9180HH9 000000L9343002 00000J10293001 00000T10294001 00000R10105001 00000L10333003 00000L10333002 000000L9343008 00000P10008001 00000H10028001 00000F10173001 00000J10113001 000000L9343006 000000G9337014 00000N10337011 00000U10061002 00000G10161003 00000M10162002 000000G9337005 000000L9343007 00000J10208003 000000L9343009 00000F10229003 00000F10229004 00000A10299001 000000L9343003 000000G9337019 000000G9337006 00000U10258001 00000U10251001 00000F10229005 00000E10083001 00000E10083002 00000E10083003 00000U10042001 00000T10123003 00000P10159001 00000400402179 00000G10271002 00000F10281001 00000G10271001 00000H10098001 000000Z9350001 00000A10194003 00000A10194002 00000L10286001 00000L10286002 00000N10337018 000000Z9309003 00000D10232002 00000E10336003 000000W9351002 0000AB10126001 00000G10312002 00000C11087001 00000X11076003 00000G10271003 000000L9343010 00000H10085001 00000D10232001 00000V10243002 00000V10243001 00000Q10188001 00000N10337004 00000N10337013 00000Q11060001 00000N10337012 00000400400243 00000400400244 0000AD10244002 00000F10229008 00000U10251002 00000AE9295001 00000D10308001 00000D10308002 00000G10312001 00000G10312003 00000G10312004 000000Z9309001 00000U10246001 000000W9351001 00000Q11070001 000000L9343001 00000D11066001
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. However, when changing the ROI (region of interest) and zooming in, the DICOM header does not change to reflect the new image, thus the line measurements may be inaccurate.
FDA Determined
Cause 2
DESIGN: Software Design
Action No consignee letter was sent out. FMI No. 25431 shows where the Field Engineer had to communicate with the hospital (Instead of them sending a letter). GE Healthcare has updated all of the affected Advantage Workstation systems affected by the GSI viewer issue. At this time, deployment of the recall is considered complete. As an effectiveness check, they have tracked all service requests for the field action to completion. These service requests record the repair of the affected units. Exceptions to completion of the service request have been recorded as well. Records of field action completion will be retained per their processes and procedures.
Quantity in Commerce 283 (59 US, 224 OUS)
Distribution US: AL, AZ, CA, CT, FL, IL, IN, IA, KY, MD, MA, MI, MS, NV, NH, NJ, NY, PA, WA, WI. OUS: AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KUWAIT, LATVIA, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWEDEN,, SWITZERLAND, TAIWAN, UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = GE HEALTHCARE
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