Events

Siemens ADVIA Centaur and ADVIA Centaur XP, bulk fluid reserve assembly 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Healthcare Diagnostics Inc 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
    17536
  • 사례 시작날짜
    2014-10-17
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • 원인
    Manufacturer has determined that on some systems a slight cracking of the tubing (the tubing for the wash1, acid, and base bottle reservoirs) at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress.The cracking may result in a minor drip of fluid onto the reservoir and into the drip tray located underneath the reservoirs. the potential for minimal fluid leakage outside the system exists. the drip will cause the reservoir to empty faster than the system expects.
  • 조치
    Product to be modified

Device

Siemens ADVIA Centaur and ADVIA Centaur XP, bulk fluid reserve assembly
  • 모델명 / 제조번호(시리얼번호)
    Model: Siemens Material Numbers: 10282187, 10483525, 10364516, and 10483526, Affected:
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc