Events

Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4 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-2016-RN-00637-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00637-1
  • 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
    On the affected ct systems and software versions, varian rpm drive is not mapped in ct user profile after logout/login. the map drive utility maps the varian drive using full varian credentials in the service login and then creates a script that maps it with full varian credentials in the ct user login. once the script has run in the ct login and the user acknowledges the drive mapped successfully, the script deletes itself. on subsequent logins, the drive will not connect because the varian credentials are no longer available. should this situation occur, the user will be unable to perform pulmonary gated scans.
  • 조치
    Philips is advising users to contact Service to login to service mode to reconnect Varian RPM drive. Philips is implementing a software upgrade as a permanent correction. This action has been closed out on 15 June 2017.

Device

Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4
  • 모델명 / 제조번호(시리얼번호)
    Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA