Events

Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations) 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-01089-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01089-1
  • 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 related to the manual film composer feature on some ct products. while following a specific workflow, there is potential to create a film image with one patient's images and another patient’s name in the footer. there is also another issue when within manual film composer, if a colour image is selected for printing, another patient’s black and white image appears in the preview screen and the colour image cannot be printed.
  • 조치
    As a temporary work around, GE is asking customers to always review the patient images and patient name on footer in the Manual Film Composer feature to ensure that they match . GE is providing temporary work around instructions on how to print the colour image from the Manual Film Composer. GE Healthcare will undertake a software update on each affected system as a permanent solution.

Device

Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)
  • 모델명 / 제조번호(시리얼번호)
    Brivo CT315/325, Brivo CT385, Optima CT520 and Optima CT540 (all configurations)ARTG Number: 93337
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd