ADVIA Centaur XP Immunoassay System (an in vitro diagnostic medical device (IVD)) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 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-2014-RN-00181-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-20
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    When the instrument cover is raised, the cover is supported by a gas spring attached at the middle of the cover. over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. this may lead to the cover falling unexpectedly.
  • 조치
    Siemens is requesting their customers to ensure that any objects placed on the cover are removed prior to opening. If the cover is unable to stay partially raised customers are requested to contact Siemens Technical Support to arrange for the gas spring to be serviced. Siemens technical support representatives will be routinely inspecting the gas spring on regular preventive maintenance cycles or service visits.

Device

  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur XP Immunoassay System (an in vitro diagnostic medical device (IVD))Siemens Material Number: 10338631ARTG Number: 175890
  • Manufacturer

Manufacturer