Events

Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354. 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-2015-RN-00116-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00116-1
  • 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 a potential safety issue involving the breakage of the steel cable which support the bucky device in certain wall stands of proteus xr/a x-ray imaging systems. a fall of a bucky while the system is in use could result in an injury to a patient or operator. there were no injuries reported as a result of this issue.
  • 조치
    GE Healthcare will inspect, and repair as necessary, all affected systems. A GE Healthcare service representative will contact customers to arrange for this correction. Additionally, the Service Procedure which defines the service interval for periodic cable maintenance and replacement is being updated to require a cable replacement every 15 years, and specify annual inspections of the counterweight guide rail bolt paint marking to confirm tightness of the bolt. This is to ensure the ongoing safe operation of this device. This action has been closed-out on 16/02/2016.

Device

Proteus XR/a X-ray imaging systems manufactured with wall stand model number 2260354.

Manufacturer

GE Healthcare Australia Pty Ltd