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U.S. Department of Health and Human Services

Class 2 Device Recall ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION

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  Class 2 Device Recall ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION see related information
Date Initiated by Firm August 18, 2011
Date Posted September 27, 2011
Recall Status1 Terminated 3 on August 09, 2012
Recall Number Z-3282-2011
Recall Event ID 59527
510(K)Number K960265  
Product Classification Radiological Image Processing System - Product Code LLZ
Product ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION
GE Medical Systems, SCS.

A software module that provides supplemental information to those images extracted from CT and MR temporal datasets.
Code Information Serial 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 00000T10152001, 00000T11116001, 00000T11117001, 00000U11028002, 00000V10130001, 00000W11027002, 00000X11031004, 00000X11049001, 00000X11108001, 00000X11108002, 00000X11108003, 00000Z10067004, 000000E9111001, 000000J9313002, 000000K9104001, 000000L9282002, 000000N9314001, 000000P9307003, 000000Q9246002, 000000Q9302001, 000000R6169001, 000000R6169002, 000000R9159001, 000000R9323001, 000000T9105001, 000000T9321001, 000000ZD906801, 000000Z9331001, 0000AA11069001, 0000AA11069002, 0000AB11118001, 0000AC11175001, 0000AD11124001, 0000AT11167001, 0000AT11167002, 0000AT11167003, 0000AT11167004, 0000AT11167005, 0000BA11122001, 00000B11161001, 00000B11161003, 00000C11167001, 00000M11171001, 00000S11159002, 00000S11159003, 00000S11159004, 00000S11159005, 00000U11032001, 00000W11172001, 00000X11158001, 00000L11180001, 00000Z11181001, 0000AM10244002, 0000AM10244003, 00000168484GE4, 00000E10069005, 000000W9334002, 0000AD11053001, 00000D10210003, 00000F10249002, 00000K10140001, 00000K10338004, 00000N10309003, 00000P10215001, 00000V10328001, 000000M9212001, 0000ZE10051001, 00000F10249007, 00000F10249008, 00000H10309001, 00000N10309005, 00000N10309007, 00000Q10267003, 00000Q10267004, 00000S11045003, 000000L9211001, 000000Y9253004, 00000173048GE0, 00000178186GE3, 0000AJ11061001, 0000AG11040001, 00000163511GE9, 00000163514GE3, 00000168486GE9, 00000168487GE7, 00000172010GE1, 00000172012GE7, 00000173046GE4, 00000181682GE6, 00000188461GE8, 00000193323GE3, 00000199302GE1, 00000176919GE9, 00000176920GE7, 00000176921GE5, 00000193328GE2, 00000207413GE6, 00000227622GE8, 00000B10109002, 00000W10167003, 00000Z10264002, 000000J9313001, 00000D10071002, 00000F10126003, 0000AD10230001, 00000Z11052001, 0000AD10245002, 00000S10165002, 000000V9289001, 000000V9289002, 000000W9329002, 000000Y9253001, 0000AT11167007, 0000AD10245003, 0000AD10327001, 0000AG10307002, 00000E10069004, 00000E10069006, 00000E10260001, 00000E10364001, 00000F10249006, 00000G11006002, 00000G11006003, 00000H10258001, 00000H10258002, 00000H10309009, 00000K10020001, 00000K10338002, 00000M11034001, 00000N10005001, 00000N10309004, 00000N10309008, 00000Q10056001, 00000Q10056002, 00000S10145001, 00000S10349003, 00000T10033003, 00000V11010002, 00000W11047001, 00000X10054001, 00000Y11012002, 00000Z10264006, 000000P9280001, 000000P9344001, 000000P9344002, 000000P9355001, 000000Q9349001, 000000R9250002, 000000V9166003, 000000V9288001, 000000W9329001, 000000Y9253002, 000000Y9253003, 000000Z9331003, 0000AB11055001, 0000AD10327003, 00000B10232003, 00000E10344009, 00000F10249003, 00000H10309007, 00000H10309008, 00000N10012002, 00000R10131001, 00000R10131003, 00000R11033001, 00000S11004003, 00000S11011005, 00000U10350002, 00000U10350003, 00000U11028001, 00000U11028005, 00000Z11052002, 000000W9257002, 0000AA11144001, 0000AA11144002, 0000AH11152001, 0000AH11152004, 0000AJ11140001, 0000AJ11140002, 0000AJ11145001, 00000S11159006, 00000T11186001, 0000AT11167006, 00000N11185001, 0000AA10141001, 00000B10109001, 00000Y10242001, 000000K9201001, 000000N9174001, 000000P9205002, 000000R6169003, 000000V9100001, 000000V9254001, 000000W9257001, 0000AD11053002, 0000AE11101001, 0000AM10244004, 00000H10309002, 00000K10020010, 00000W11027001, 00000Y10242002, 000000K9082001, 000000K9181001, 000000U9107001, 00000P10137004, 00000T10033002, 000000K9082006, 0000AE10155003, 00000L10334005, 00000U10062003, 000000F9146005, 00000E10069002, 00000N10309006, 000000L9196001, 000000Q9246001, 000000Y9231001, 00000D10071003, 00000L10334004 00000V11077001, 000000T9245003, 000000W9287001, 0000AE11139001, 0000AQ11137001, 000000R6169005, 000000W9257005, 000000N9314002, 00000X11131001, 00000Y11130001, 000000M9218001, 00000S10349001, 00000Z10067008, 000000P9132001, 00000K10020006, 00000M10169001, 000000P9328001, 000000R6169004, 000000X9293001, 00000R10119001, 00000D10210006, 00000D10210007, 00000F10126002, 00000K10118001, 00000Q10285002, 00000R10117002, 00000S10104001, 00000S11045001, 00000X10159003, 00000Z10067006, 00000Z10067007, 000000J9208001, 000000P9132002, 000000P9132003, 000000Y9231002, 000000Y9231003, 000000Z9133002, 000000Z9331002, 0000AE10155004, 0000AG11102001, 00000A10222001, 00000D10071004, 00000D10218001, 00000D10218002, 00000D10218003, 00000E10069007, 00000F10249004, 00000G11006004, 00000J10180002, 00000J10252002, 00000K10020007, 00000K10118002, 00000P10137003, 00000Q10202001, 00000R10181002, 00000U10062001, 00000U10187001, 00000V10208001, 00000W10064001, 00000X10061001, 00000Z10067011, 000000F9146001, 000000F9146002, 000000F9146003, 000000K9082003, 000000L9209001, 000000S9135001, 000000Z9148001, 00000W10355001, 00000Z10228002, 00000Z10228003, 000000L9282001, 00000178187GE1, 00000G11006001, 00000G11006005, 00000Z10264005, 000000S9219001, 00000188462GE6, 00000B10190001, 000000L9299002, 00000Q10267002, 00000R10168001, 00000227624GE4, 00000199303GE9, 00000224813GE6, 00000226749GE0, 00000239640GE6, 00000235770GE5, 00000181680GE0, 00000211309GE0, 00000224812GE8, 00000186713GE4, 000000T9327002, 00000156055GE6, 00000156056GE4, 00000156058GE0, 00000156059GE8, 00000160139GE2, 00000163512GE7, 00000163513GE5, 00000172011GE9, 00000172013GE5, 00000173045GE6, 00000173047GE2, 00000174342GE6, 00000178182GE2, 00000181681GE8, 00000181684GE2, 00000188463GE4, 00000188464GE2, 00000190788GE0, 00000190789GE8, 00000190790GE6, 00000190792GE2, 00000193325GE8, 00000193326GE6, 00000193327GE4, 00000197291GE8, 00000199299GE9, 00000199301GE3, 00000199304GE7, 00000202802GE5, 00000202803GE3, 00000202805GE8, 00000213648GE9, 00000160137GE6, 00000160140GE0, 00000168485GE1, 00000177461GE1, 00000178183GE0, 00000178184GE8, 00000188459GE2, 00000197288GE4, 00000202807GE4, 00000207408GE6, 00000207409GE4, 00000207410GE2, 00000207411GE0, 00000207412GE8, 00000211313GE2, 00000226751GE6, 00000227620GE2, 00000227623GE6, 00000227625GE1, 00000230388GE1, 00000230392GE3, 00000235767GE1, 00000235768GE9, 00000235771GE3, 00000239641GE4, 00000239643GE0, 00000P10256001, 0000AA10243002, 00000E10069008, 00000X10054002, 0000AE11063001, 00000T10033004, 00000S10165001, 0000AD10230002, 000000Q9330001, 00000U11028003, 00000197287GE6, 00000213649GE7, 00000226748GE2, 00000227621GE0, 00000230393GE1, and 00000Y11109001.
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall		 GE Healthcare has become aware that image orientation of reference series displayed in Functool Diffusion Tensor/FiberTrak protocol on Advantage Workstation may not match with the orientation annotations displayed in the viewport. This issue may impact patient safety.
FDA Determined
Cause 2		 Software design
Action GE Healthcare sent "Urgent Medical Device Correction" letters dated August 18, 2011 to all affected customers. The letter included name of product affected and described problem. Recommended actions where provided to customers and they were notified a GE Healthcare representative will contact them for a software system upgrade. For question of this recall contact the GE Service Representative at (800) 437-1171.
Quantity in Commerce 697
Distribution Worldwide Distribution: Nationwide distribution including the states of AZ, CA, CT, DC, FL, ID, IL, KY, LA, MD, MI, MN, NJ, NY, OR, PA, PR, TN, TX, VA, WA, and WI; and the countries of VIETNAM, MEXICO, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SWITZERLAND, SWEDEN, ST HELENA, SPAIN, SLOVENIA, SINGAPORE, SAUDI ARABIA, RUSSIAN F¿D¿RATION, ROMANIA, REUNION, REPUBLIC OF CHINA, QATAR, PORTUGAL POLAND, PARAGUAY, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LUXEMBOURG, LIBYA, KUWAIT, KOREA, JAPAN, ITALY, ISRAEL, INDONESIA, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, CZECH REPUBLIC, CROATIA, COSTA RICA, COLOMBIA, CHILE, CANADA, BELARUS, BRAZIL, BOSNIA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA, and ARGENTINA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS
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