Retiro De Equipo (Recall) de ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    59527
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3282-2011
  • Fecha de inicio del evento
    2011-08-18
  • Fecha de publicación del evento
    2011-09-27
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-08-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Radiological Image Processing System - Product Code LLZ
  • Causa
    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.
  • Acción
    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

  • Modelo / 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.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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

  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA