Events

Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E(fluoroscopic and standard diagnostic x-ray 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-2015-RN-00361-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00361-1
  • 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
    Images might be lost and corresponding acquisitions have to be repeated under the following circumstances:· during an image recovery process on systems with portable detectors (max wi-d, max mini) the connection of the portable detector is sporadically not re-established.· if either the “undo” button on the rad subtask card or the “previous series” button on the image subtask card are pressed during image readout.· sporadically, during an automatic or a manual ris update. this may cause the deletion of the currently used study and all acquired images within this study.
  • 조치
    Siemens is providing temporary instructions for users to follow to prevent the issues from occurring. A software update will be available in Q2 2015 which will permanently resolve the issue. This action has been closed-out on12/08/2016.

Device

Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version ...
  • 모델명 / 제조번호(시리얼번호)
    Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E(fluoroscopic and standard diagnostic x-ray systems )Catalogue Numbers: 10762470, 10762471ARTG Numbers: 102184, 102182, 213886
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd