Events

IMAGE PASTING PATIENT BARRIER 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
    132271
  • 사례 위험등급
    II
  • 사례 시작날짜
    2011-10-19
  • 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
    Ge healthcare has become aware of a potential issue associated with the patient barrier rotating arm that is a part of the definium 8000 and discovery xr650 image pasting systems that may impact patient and/or user safety. the patient barrier rotating arms that are used to position and stabilize the patient during image pasting procedures may fail to retain residual friction at the arm pivot. this could permit the arm to swing freely when the rotating arm locking lever is released. should this happen during use injury to the patient and/or user could occur.

Device

IMAGE PASTING PATIENT BARRIER

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)