Events

Artis Q Systems with A100G generators 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-00303-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00303-1
  • 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
    In artis systems with a100g generators, a component can be affected by ageing, resulting in the failure of a module in the high-voltage generator. when the failure occurs, the system usually responds by providing emergency fluoroscopy. in the worst case, a spontaneous failure of the radiation generation function is conceivable. in the event of a spontaneous failure, it may be necessary to cancel or restart a clinical treatment or transfer it to a functioning system.
  • 조치
    Siemens is advising users that potentially affected modules will be replaced. Users are further advised to implement standard emergency processes in the event of a system failure and to have these processes carefully prepared until the affected modules are replaced.

Device

Artis Q Systems with A100G generators
  • 모델명 / 제조번호(시리얼번호)
    Artis Q Systems with A100G generators Catalogue Numbers: 10848353, 10848354, 10848355, 10848280, 10848281, 10848282, 10848283ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd