Events

Siemens Dimension Vista 500 and Dimension Vista 1500 analysers 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Siemens Healthcare Diagnostics (UK) 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
    18554
  • 사례 시작날짜
    2015-05-21
  • 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 2 issues when using dimension vista analysers with specified software versions., 1/ samples may stop processing without notification on the dimension vista 500 or dimension vista 1500. this issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable., 2/ complaints were received on the dimension vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. it has been determined that under a rare set of conditions, a timing issue may cause a reagent server to temporarily lose synchronization during the automatic removal of reagent cartridges from reagent server 2 to waste a container.
  • 조치
    Software to be upgraded

Device

Siemens Dimension Vista 500 and Dimension Vista 1500 analysers

Manufacturer

Siemens Healthcare Diagnostics (UK) Ltd