Events

Revolution CT (diagnostic x-ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare Australia Pty Ltd 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
    RC-2016-RN-00640-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00640-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Ge healthcare has become aware of a potential safety issue in the revolution ct patient table that can result in unintended motion in cases involving large patients. the revolution ct cradle can descend on its own after activation by the user. this can put the patient at risk for harm. the harm can involve the impinging or crushing of a hand if caught between the cradle and ct inner gantry bore. no injuries have been reported to date related to this issue.
  • 조치
    GE Healthcare is advising users to continue to use the Revolution CT system, and ensure the warnings regarding Patient Positioning in the IFU are followed. GE will be correcting all affected systems. This action has been closed-out on 20/02/2017.

Device

Revolution CT (diagnostic x-ray system)

Manufacturer

GE Healthcare Australia Pty Ltd