Events

OPTIMA XR220AMX X-RAY SYSTEM 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
    26856
  • 사례 위험등급
    III
  • 사례 시작날짜
    2012-09-11
  • 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
    Software defect where under certain instances and protocols the image from the scan will not appear requiring a rescan. the three problematic instances are the following: the customer selects the next protocol in a multiple exposure exam while the previous image is displayed. the detector management window is opened while the protocol is opening on the user interface. the auto protocol assist feature is utilized and one of the protocol codes is not matched to one in the system database.

Device

OPTIMA XR220AMX X-RAY SYSTEM

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)