Events

Siemens Advia Centaur XPT System 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
    18834
  • 사례 시작날짜
    2015-07-09
  • 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
    Siemens has identified a number of workflow issues with advia centaur xpt system software v1.0.1 and v1.0.2:, * the system does not display any indication of a missing required probe wash pack on the results screen., * the data shown on the "utilities->assay utilization" screen is incorrect for the totals of calibrators run on the instrument, * the data shown on the "utilities->assay utilization" screen and the printout report for assay utiliization may not match, the following issues are related to instruments connected to a lab automation system (las):, * if the instrument receives work orders while transition from the in-process state to the ready state, the sample will be routed to the instrument but may not be processed, *the system may stop processing samples from the las and hold a tube at the las sampling station.
  • 조치
    Software to be upgraded

Device

Siemens Advia Centaur XPT System
  • 모델명 / 제조번호(시리얼번호)
    Model: 10711433, Affected: All serial numbers manufactured from Oct-2014 to Feb-2015
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

Siemens Healthcare Diagnostics Inc