Events

PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44 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-2013-RN-01265-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01265-1
  • 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
    A software issue exists when using list mode replay feature, such that subsequent reconstructions with that data could contribute to an image with scatter over-estimation and overcorrection artifacts which may be presented as 'black background' and creates an apparent perfusion defect. reconstructed images with this issue will have many fewer counts than the acquired scan data and a high scatter fraction. this issue may affect studies that use list mode replay and are reconstructed after subsequent acquisitions. this issue may lead to image misinterpretation and/or inaccurate treatment decisions.
  • 조치
    GE Healthcare is providing users with work around instructions to follow as an interim measure. A software upgrade will be performed as a permanent fix.

Device

PET Discovery 610 and Discovery 710 with software version pet_coreload.44 and pet_mfk.44

Manufacturer

GE Healthcare Australia Pty Ltd