Events

Discovery XR656 Wall Stand System (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-2014-RN-00834-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00834-1
  • 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 recently become aware of two flashpad detector falls due to a broken nylon support hook. a detector fall could result in an injury to a patient or operator. there have been reported incidents of detector falls, but no injuries have been reported.
  • 조치
    Users are advised that if they observe either one of the nylon support hooks as broken or loose on the Discovery XR656 wall stand system, immediately stop use and contact their local GE Healthcare Service Representative. If the hooks are not broken, users may continue to use the wall stand system. GE Healthcare is correcting all affected systems by replacing the nylon hooks. This action has been closed-out on 03/06/2016. This action has been closed-out on 03/06/2016.

Device

Discovery XR656 Wall Stand System (X-ray system)
  • 모델명 / 제조번호(시리얼번호)
    Discovery XR656 Wall Stand System (X-ray system)Part Numbers: 5374989 and 5397837Serial numbers: 00000100365HL6, 00000099847HL6, 00000109154HL5, 00000108716HL2, 00000109561HL1, 00000109564HL5ARTG Number: 167617
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd