ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD). 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-00208-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-08
  • 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
    Multiple software issues have been identified for software versions v1.0 to v1.2. these issues may affect the operation and workflow of the advia centaur xpt system, and the potential exists for an apparent delay to testing. the issues are detailed in the customer letter and relate to the following: system status unknown, las communication, qc profiles, 'no primary' error, and lis specification.
  • 조치
    The software issues will be corrected in future software versions. In the interim, Siemens is providing detailed work around instructions in the customer letter. It is recommended that the letter is reviewed with the laboratory Medical Director.

Device

  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur XPT System with software versions V1.0 to V1.2. An in vitro diagnostic medical device (IVD).Siemens Material Number: 10711433Software versions: V1.0.1 (Bundle 1.0.912 SMN 10819704)V1.0.2 (Bundle 1.0.1086 SMN 11219806)V1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656)V1.1 (Bundle 1.1.243 SMN 11221979, 11222064)V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813)ARTG Number: 175890
  • Manufacturer

Manufacturer