Rappel de ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par GE Healthcare, LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    59527
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3282-2011
  • Date de mise en oeuvre de l'événement
    2011-08-18
  • Date de publication de l'événement
    2011-09-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-08-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Radiological Image Processing System - Product Code LLZ
  • Cause
    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

  • Modèle / numéro de série
    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.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Manufacturer

  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
  • Source
    USFDA