ADVIA CENTAUR CP SYSTEM - INSTRUMENT CLASS IV 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 SIEMENS HEALTHCARE LIMITED 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
    16141
  • 사례 위험등급
    III
  • 사례 시작날짜
    2016-04-04
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    There are two inaccuracies that exist in the advia centaur cp operator's guide appendix d pre-set tube types. the first refers to the sample volume supported by the system when using the ezee-nest cup to process samples. the operator's guide states that sample volumes greater than 50 ul can be used however volumes greater than 150 ul cannot be used when using an ezee-nest insert cup. the second refers to the use of the universal cup adaptor with an ezee-nest insert cup in 65-mm sample racks. siemens has determined that the height of an ezee-nest insert cup with universal cup adaptor fitted on a 65-mm sample rack will not fit into the sample compartment. no samples will be processed.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 086-A002-01 (Lot serial: ALL); Model Catalog: 09662772 (Lot serial: ALL)
  • 제품 설명
    ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS IV;ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS III;ADVIA CENTAUR CP SYSTEM-INSTRUMENT CLASS II
  • Manufacturer

Manufacturer

  • 제조사 주소
    OAKVILLE
  • 제조사 모회사 (2017)
  • Source
    HC