Events

MR APPLICATIONS 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 GENERAL ELECTRIC CANADA (OPERATING AS 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
    17414
  • 사례 위험등급
    III
  • 사례 시작날짜
    2013-08-19
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Cardiacvx and cardiacvx flow report higher than actual flow values on phase-contrast images acquired with magnitude weighting mask enabled. note that this issue can only occur on phase contrast mr protocols with the magnitude weighting mask option enabled. in the fast cine phase-contrast sequence the magnitude weighting mask is a user configurable option (control variable or cv). in the 2d cine phase-contrast sequence (non-fast mode) magnitude weighting mask is always on and thus would always result in this issue. the issue may result in an incorrect diagnosis if higher than actual flow values are not noticed.

Device

MR APPLICATIONS
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 5434388-X (Lot serial: 00000L0240862D); Model Catalog: 5434388-X (Lot serial: 00000287170GE5); Model Catalog: 5434388-X (Lot serial: 00000287171GE3); Model Catalog: 5434388-X (Lot serial: 00000322015GE9); Model Catalog: 5434388-X (Lot serial: 00000328735GE6); Model Catalog: 5434388-X (Lot serial: 00000281269GE1)
  • 제품 설명
    CARDIACVX
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)