TumorLOC (intensity projection dataset software) use with: Brilliance CT Big Bore, EBW, GEMINI LXL, GEMINI TF 16, GEMINI TF 64 & GEMINI TF Big Bore (radiology systems) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2012-RN-01223-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-12-04
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 tumorloc application has the capability to generate intensity projection datasets from respiratory gated data. a circumstance has been identified where these generated datasets are flipped and incorrectly labelled left to right when they are saved to disk.
  • 조치
    Work around instructions will be provided to customers to avoid the problem. A software update is under development and will be implemented once complete. This action has been closed-out on 11/04/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    TumorLOC (intensity projection dataset software) use with: Brilliance CT Big Bore, EBW, GEMINI LXL, GEMINI TF 16, GEMINI TF 64 & GEMINI TF Big Bore (radiology systems)Multiple affected serial numbersARTG Number: 117441
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA