Events

GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455) 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-00699-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00699-1
  • 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 that the service procedure used to replace a power supply on the rotating side of the gantry specified the incorrect torque for the mounting hardware. because of this error, the three mounting bolts securing the power supply could have been over-torqued when the component was replaced on your system. plastic deformation of the bolts from over-torqueing could worsen over time and eventually fail. however, all 3 bolts holding the power supply would have to fail for the part to fall. in the unlikely event that the component becomes loose on the ct gantry during operation, it could result in serious bodily injury if the component were to be expelled. there have been no incidents or injuries reported as a result of this procedure error.
  • 조치
    GE Healthcare will correct all affected products at no cost to users. This action has been closed-out on 15/08/2016.

Device

GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Powe...
  • 모델명 / 제조번호(시리얼번호)
    GE Healthcare LightSpeed CT scanners & Discovery PET CT scanners with replacement MDAS 16 5V Power Supply (part number 2334455) Affected Product: The following CT Scanners, manufactured from 2003 – 2006:· LightSpeed Ultra (8-slice MDAS)· LightSpeed Plus (4-slice MDAS)· LightSpeed QX/i (4-slice MDAS)· LightSpeed 16 (MDAS Only)The following PET CT Scanners, manufactured from 2003 – 2005:· Discovery ST· Discovery LS ARTG Numbers: 96044 and 156649
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd