Events

AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system) 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-2016-RN-00229-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00229-1
  • 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
    Due to a leak in the cooling system, fluids could seep into the equipment cabinet. this leak can occur sporadically in the affected systems. the issue was identified during regular field observations. in this case, there was a leak in the hose connectors. loss of coolant can result in cooling system failure, and in a worst case scenario, this leak can cause system failure.
  • 조치
    Siemens are advising users that service personnel will be replacing the affected couplings in order to prevent the issue from occurring.

Device

AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)Catalogue Numbers: 7555365, 10094141, 10094139, 10094137, 10094135, 10280959, 10848281, 10848280, 10848282, 7413078, 7412807, 7008605, 10848355, 7728392, 7555357, 7727717ARTG Numbers: 102173 and 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd