Events

OPTIMA MR450W MRI SYSTEM - MAIN UNIT - GEM 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
    27248
  • 사례 위험등급
    II
  • 사례 시작날짜
    2013-04-04
  • 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
    Devices may generate non-unique series identifiers which when exported to some pacs systems results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. the issue may result in an incorrect diagnosis from the study with mixed patient data if the series protocol and anatomy on the studies are similar and the annotation is not noticed. the conditions under which the issue is known to be possible require that the studies have identical time of day and that the exams be on an affected model of pacs at the same time.

Device

OPTIMA MR450W MRI SYSTEM - MAIN UNIT - GEM
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: M7000ZJ (Lot serial: N/A); Model Catalog: M7000BB (Lot serial: N/A); Model Catalog: M7000WB (Lot serial: N/A); Model Catalog: M7000WA (Lot serial: N/A); Model Catalog: M7000BH (Lot serial: N/A); Model Catalog: M7000WC (Lot serial: N/A)
  • 제품 설명
    OPTIMA MR450W MRI SYSTEM - GEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)