Events

Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic 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-00462-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-04-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00462-1
  • 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
    The service procedure describing replacement of a power supply on the rotating side of the gantry specifies the wrong torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could be over-torqued if the component is replaced on your system. in the unlikely event that the bolts fail on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled. there have been no reports of this issue.
  • 조치
    GE has updated the Service Manuals for the affected products to update an incorrect torque value and is advising users to ensure the organisation that services the affected equipment uses the latest version of the Service Manual. The latest version of the Service Manuals can be downloaded from the GE document library. This action has been closed-out on 30/01/2017.

Device

Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diag...
  • 모델명 / 제조번호(시리얼번호)
    Lightspeed CT, Discovery PET/CT (Computed tomography x-ray and nuclear medicine gamma camera diagnostic systems)CT Scanners:LightSpeed Ultra (8-slice MDAS)LightSpeed Plus (4-slice MDAS)LightSpeed QX/i (4-slice MDAS)LightSpeed 16 (MDAS Only)PET/CT Scanners:Discovery STDiscovery LSARTG Numbers: 96044, 128982
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd