Artis zee and Artis Q systems with software version VD11C 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-2017-RN-01186-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-09-13
  • 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
    Siemens has identified an issue whereby in the application “dsa roadmap” the artis system's intended behaviour is to reject the stored vesselmap from previously acquired dsa if the patient table was moved during the roadmap workflow. in rare cases the system does not reject the dsa vesselmap and uses it for the further roadmap workflow steps. depending on the amount of table movement which was applied during the roadmap workflow, the dsa vesselmap may be overlaid as vessel tree at a position which does not fulfil siemens' requirements for accuracy.If the displacement of the vessel tree is large, it may be recognised by the user. however, if the displacement is either slight or at an unfavourable plane, the user may rely on incorrect visualisation of the catheter relative to the vesselmap.
  • 조치
    1. The software in affected systems will be updated to correct the issue. 2. Users are to return the supplied acknowledgement form. 3. If the device is no longer in their possession forward the notice to the new owners. 4. Siemens will contact users to arrange a time to perform the software upgrade.

Device

  • 모델명 / 제조번호(시리얼번호)
    Artis zee and Artis Q systems with software version VD11CCatalogue/Lot Numbers: 10094137, 10848281, 10848282, 10848280, 10848283, 10094135, 10094139, 10848355, 10280959 and 10848353ARTG Number: 273952
  • Manufacturer

Manufacturer