Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) 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-2015-RN-00612-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-08
  • 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
    Artis system has an x-ray locking function that prevents any accidental release of radiation. if the systems enters "bypass fluoro" mode while the x-ray locking function is active a system error can occur which makes it impossible to exit the locking function without restarting the system or resolving the cause of the "bypass fluoro".In the situation described, no radiation is possible and no fluoroscopic images can be acquired.
  • 조치
    Siemens is developing a software patch to ensure that the Artis system automatically unlocks the radiation release in "Bypass Flouro" mode. This will ensure that imaging is possible in all cases. This action has been closed-out on 22/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)Catalogue/Lot number – 10094137, 10094135, 10094141, 10094139, 10280959 with software version VC14JARTG Number: 102177
  • Manufacturer

Manufacturer