Events

Sensis 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-2017-RN-00521-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00521-1
  • 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 sensis systems, a computer that is extremely dusty can cause problems when starting the system. in rare cases, it can cause the sensis to fail. the system's functions cannot be used in the event of a failure and as a result, clinical treatment may need to be terminated, restarted, or transferred to a functioning system.
  • 조치
    Siemens is currently working on a solution and will update users in the second quarter of 2017. In the interim, users are requested to conduct a system check to ensure that the system is functioning properly prior to performing an examination. In the event that the system fails to start within the time and parameters described in the operator manual, users are requested to notify Siemens Service, and terminate, restart or transfer clinical treatment to a functioning system. Users are to ensure that standard emergency processes are in place for implementation in the event of a system failure.

Device

Sensis system
  • 모델명 / 제조번호(시리얼번호)
    Sensis systemCatalogue Numbers: 6634633, 6623974, 10764561 and 11007641ARTG Number: 273953
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd