Device Recall GE Healthcare Advantage Workstations 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
    61614
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2203-2012
  • 사례 시작날짜
    2012-05-24
  • 사례 출판 날짜
    2012-08-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-12-11
  • 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
    System, image processing, radiological - Product Code LLZ
  • 원인
    Ge healthcare is informing you of incorrect measurements when using the aorta analysis protocol or customized protocols. until a new software version is installed they are asking you not to use the aorta analysis protocol or the customized protocols for an aneurysm. a second issue was also discovered internally. when loading pet data into the volume viewer, if slices are missing in a pet serie.
  • 조치
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated May 23, 2012 to consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers & Radiologists. The letter described the affected product details, safety issue, safety instructions and product correction. For more information on this topic, contact a GE Application Specialist or your GE Field Service representative. For questions or concerns regarding this notification, please call one of the following phone numbers: United States: 800 437 1171 Japan: 0120 - 055 - 919 For other countries, please contact your local GE Healthcare Service Representative

Device

  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) including the states of : AL, AZ, AR, CA, CO, DE, DC, FL, GA, GU, HI, IK, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO,MT, NE,NH,NJ, NM, NY, NC, ND, OH, OK, PA, PR, SC, SD, TN, TX, VA, WA, WV, WI and the countries of YUGOSLAVIA, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TURKEY, TUNISIA, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SA¿DE ARABIA, RUSSIAN FEDERATION, ROMANIA, REPUBLIC OF MALTA, PORTUGAL, POLAND, PHILIPPINES, NORWAY, NIGERIA, NEW ZEALAND, MEXICO, KOREA, KENYA, JAPAN, ITALY, IRELAND, INDONESIA, INDIA, HUNGRY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA.
  • 제품 설명
    GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis (AVA), Model 2378698-2 || Product Usage: || Advantage Workstation version 4.2: The Advantage Workstation 4.2 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images may be used as an element for diagnosis. Advantage Workstation version 4.3/4.4 : The Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing, filming and medial interchange of multi-modality DIACOM images from a variety of diagnostic imaging systems. When interpreted by a trained physician, filmed images of the AW monitor may be used as a basis for diagnosis, except in the case of mammography.
  • Manufacturer

Manufacturer

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