Events

Recall of ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59527
  • Event Risk Class
    Class 2
  • Event Number
    Z-3282-2011
  • Event Initiated Date
    2011-08-18
  • Event Date Posted
    2011-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103023
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Radiological Image Processing System - Product Code LLZ
  • Reason
    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.
  • 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.

Device

ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION
  • Model / Serial
    Serial Numbers: 00000156053GE1, 00000156054GE9, 00000160141GE8, 00000160142GE6, 00000163510GE1, 00000177462GE9, 00000177463GE7, 00000178185GE5, 00000181683GE4, 00000188460GE0, 00000190791GE4, 00000193324GE1, 00000197286GE8, 00000197290GE0, 00000199300GE5, 00000211314GE0, 00000213647GE1, 00000224809GE4, 00000224810GE2, 00000235766GE3, 00000154900GE5, 00000156057GE2, 00000163515GE0, 00000174344GE2, 00000176430GE7, 00000177464GE5, 00000183715GE2, 00000190793GE0, 00000197289GE2, 00000202806GE6, 00000211312GE4, 00000224811GE0, 00000230390GE7, 00000230391GE5, 00000235769GE7, 00000239644GE8, 00000B10232002, 00000R10048002, 00000S10145004, 00000Z11048001, 00000P10256003, 00000S10349006, 00000Y11012001, 000000U9229001, 0000AD11124002, 0000AH11070001, 00000E10344008, 000000F9146004, 000000F9146006, 000000R9210001, 000000R9250003, 0000AG11102002, 0000ZD10349001, 00000F10186001, 00000R11013001, 00000S11004001, 00000T11062001, 00000U11056001, 000000L9299001, 000000Q9349002, 000000T9285001, 00000C11167002, 00000P10137001, 00000R10117001, 00000H10158001, 00000K10140002, 00000X10159002, 00000Z10067005, 00000E10344005, 00000AB9251002, 00000D10210004, 00000K10020008, 00000T10224001, 000000V9254002, 0000AG11073001, 0000AB10071002, 00000F10249005, 00000L10334006, 00000X10159001, 000000Q9302002, 000000R9323002, 0000AD10327005, 0000AD10327006, 00000Z10333001, 0000AE10155002, 00000D10071005, 00000K10020005, 00000T10033007, 000000L9299003, 0000AD10245001, 0000AD11096001, 00000S11011001, 00000E10069003, 00000L10334003, 00000R10168002, 000000F9175001, 0000AP11119001, 00000D10210002, 00000E10344010, 00000K10020003, 00000L10334001, 00000N10116001, 00000P10050001, 00000P10356001, 00000P10357002, 00000Q10285001, 00000S10349005, 00000S11004002, 00000S11011006, 00000S11011007, 00000U10350001, 00000W10167002, 000000Q9281002, 000000U9204001, 000000W9257004, 000000Z9191001, 00000S11150001, 000000Z9202001, 00000AB9251001, 00000AB9251003, 00000S11011003, 000000K9082005, 00000L11132001, 00000M10057002, 00000V10055001, 0000AG10307003, 00000T11038001, 00000T11038002, 00000X11031002, 00000X11031003, 0000AH11152002, 0000AH11152003, 00000A10222002, 00000V10130002, 00000Z10264001, 0000AD10245006, 00000Z11111001, 000000S9217001, 00000X11125001, 000000P9307004, 00000H10309005, 00000S11060001, 000000X9131001, 0000AA10182001, 0000AA10243001, 0000AA10330001, 0000AD10230003, 0000AD10245004, 0000AD10245005, 0000AD10250001, 0000AD10327002, 0000AD10327004, 0000AE10155001, 0000AG10307001, 0000AG10307004, 0000AH10126001, 0000AM10244001, 0000ZF10239001, 00000AB9244001, 00000B10232001, 00000B10232004, 00000B10232005, 00000D10071001, 00000E10069001, 00000E10139001, 00000E10139002, 00000E10344006, 00000E10344007, 00000E10344011, 00000E10344012, 00000F10249001, 00000F10249009, 00000H10309003, 00000H10309004, 00000H10309010, 00000J10180001, 00000J10252001, 00000K10020009, 00000K10118003, 00000K10147001, 00000K10338003, 00000K10338005, 00000K10338006, 00000K10338007, 00000K10338008, 00000L10015002, 00000L10334002, 00000L10334008, 00000M10057001, 00000M10169002, 00000N10012001, 00000N10161001, 00000N10203002, 00000N10309002, 00000N10309009, 00000N10309010, 00000N10309011, 00000N10309012, 00000P10112001, 00000P10137002, 00000P10137005, 00000P10256002, 00000Q10267001, 00000Q10267005, 00000Q10267006, 00000Q10267007, 00000Q10299001, 00000R10048001, 00000R10049001, 00000R10131002, 00000R11033002, 00000R11033003, 00000S10111001, 00000S10145002, 00000S10145003, 00000S10145005, 00000S10349004, 00000S11011002, 00000S11011004, 00000T10033001, 00000T10033005, 00000T10033006, 00000T10033008, 00000T10152002, 00000T10224002, 00000T10238001, 00000T10238002, 00000U10062002, 00000U10127001, 00000U10187003, 00000U11028004, 00000U11067001, 00000V10043001, 00000V10298001, 00000V10328002, 00000V11010001, 00000W10167001, 00000X10159004, 00000X10162001, 00000ZB9348001, 00000Z10067001, 00000Z10067002, 00000Z10067003, 00000Z10067010, 00000Z10067012, 00000Z10228001, 000000D9145001, 000000F9146007, 000000J9336001, 000000J9352001, 000000K9082002, 000000K9082004, 000000K9082007, 000000K9139001, 000000K9139002, 000000K9335001, 000000P9205001, 000000P9307001, 000000P9307002, 000000P9317001, 000000P9317002, 000000Q9239001, 000000Q9337001, 000000Q9345001, 000000R9159002, 000000R9198001, 000000R9198002, 000000R9250001, 000000S9117001, 000000T9105002, 000000T9245001, 000000T9245002, 000000T9327001, 000000T9327003, 000000V9100002, 000000V9100003, 000000V9138001, 000000V9138002, 000000V9166001, 000000V9166002, 000000W9257003, 000000W9334001, 000000Y9253005, 000000Z9133001, 000000Z9202002, 000000Z9203001, 0000AC11059001, 0000AE11101002, 0000AG11040002, 0000AH11070002, 0000AJ10214001, 00000D10210001, 00000D10210005, 00000E10139003, 00000E10344001, 00000E10344002, 00000E10344003, 00000E10344004, 00000E10364002, 00000F10126001, 00000G10148001, 00000K10020002, 00000K10147002, 00000K10338001, 00000K11095001, 00000L10334007, 00000N10309001, 00000P10018001, 00000R10181001, 00000R10181003, 00000S11045002, 00000S11087001, 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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA