Events

DISCOVERY NM/CT 670 SYSTEM - NM GANTRY 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
    54873
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-12-22
  • 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
    Ge healthcare has recently become aware of an issue associated with the collimator cart and lead cover of the discovery nm/ct 670 and/or discovery nm 630 system that may impact operator safety. they are: 1. the cart locking pin release and cart disengagement could result in the collimator falling down and could lead to operator or service personnel injury. 2. another issue is that the lead cover handle separation could result in plate swing resulting in potential injury to service personnel. please note there are no affected install units for the discovery nm 630.

Device

DISCOVERY NM/CT 670 SYSTEM - NM GANTRY

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)