Events

Artis systems used in conjunction with Artis table 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-2015-RN-00677-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00677-1
  • 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
    For artis systems used in conjunction with artis table;- in the event the tabletop is approximately fully extended at the head end and there is a large amount of liquid on the table surface, the liquid may make its way from the foot end of the tabletop onto the top cover of the table column where it can seep through a gap. this liquid may then cause interference with electronic components and table movements may no longer be possible.
  • 조치
    The gap in the top of the table cover will be sealed to ensure protection against the entry of liquids.

Device

Artis systems used in conjunction with Artis table
  • 모델명 / 제조번호(시리얼번호)
    Artis systems used in conjunction with Artis tableCatalogue and Serial number – Multiple serial number ranges of Artis tables with the following Siemens Material Numbers: 5767004 5767012 5767020 5767053 10759275 10759276 10759277 10759278ARTG number – 102173 and 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd