Events

Artis zee and Artis zeego systems 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2014-RN-00775-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00775-1
  • 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
    Under certain circumstances the release of radiation can become blocked unnecessarily. the system to block the release of radiation after the system has booted up if an error occurs with the large display. the radiation block remains even if the error that triggered the block was a temporary one or has been cleared.
  • 조치
    Siemens is providing a software patch to correct this issue. The software limits the blockage of radiation release to three seconds and the screen in the control room displays the message "No Xray, try again". After the next attempt, radiation can then be released without restriction. This action has been closed-out on 02/06/2016.

Device

Artis zee and Artis zeego systems
  • 모델명 / 제조번호(시리얼번호)
    Artis zee and Artis zeego systemsMultiple material numbers with software VC21B and Large DisplayARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd