Events

Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems 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-00001-2
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00001-2
  • 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 related to the operation of the safety latch holding mechanism for the horizontal arm of the x-ray system. this safety latch mechanism serves as a backup in the unlikely event the primary safety cable breaks. in order to encounter the hazardous situation where the x-ray tube horizontal arm falls, it would require the following condition to occur simultaneously which is highly unlikely:1) the counter weight cable system (steel cable or pulley/idler) breaks.2) the safety mechanism does not engage and hold the tube–arm there have been no incidents or injuries reported as a result of this internally found issue.
  • 조치
    GE Healthcare will correct all affected products. In the interim, users are advised to continue to use the system with caution. This action has been closed-out on 27/01/2017.

Device

Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems
  • 모델명 / 제조번호(시리얼번호)
    Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systemsAll serial numbersARTG Number: 201698
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd