ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare, LLC 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    59527
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3282-2011
  • 사례 시작날짜
    2011-08-18
  • 사례 출판 날짜
    2011-09-27
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-08-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Radiological Image Processing System - Product Code LLZ
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA