Device Recall Advantage Workstation 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 GE Healthcare 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
    48738
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2312-2008
  • 사례 시작날짜
    2008-05-01
  • 사례 출판 날짜
    2008-09-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-12-11
  • 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 has recently became aware of a possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the advantage workstation that may impact patient safety.
  • 조치
    Consignees were sent a GE "Urgent Field Safety Notice" letter dated March 13, 2008 addressed to Hospital Administrators; Managers of Radiology/Cardiology; Radiologists/Cardiologists on May 2008. The letter described the safety issue, affected product, product correction, safety instructions and contact information. A GE Field Engineer to visit site to implement the correction (FMI No. 25409). Contact information: 800-437-1171 (USA); 0120-055-919 (Japan); 0800-15-25-25 (France); for all other countries contact your local GE Healthcare sales or field representative.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Algeria Argentina Australia Austria Belgium Bosnia Brazil Bulgaria Byelorussian SSR Canada Chile China Columbia Croatia Cyprus Czech Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Guadeloupe Guatemala Guyana Honduras Hungary India Indonesia Iran Ireland Israel Italy Jamaica Japan Korea Kuwait Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macedonia Malaysia Mexico Morocco Netherlands New Zealand Norway Oman Pakistan Panama Paraguay Peru Philippines Poland Portugal Puerto Rico Puerto Rico Romania Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Thailand Trinidad Tunisia Turkey Ukraine United Aran Emirates United Kingdom Uruguay Venezuela Vietnam Yugoslavia
  • 제품 설명
    Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.
  • Manufacturer

Manufacturer

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