Events

Leica ASP 200S Analyser 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Leica Instruments Singapore Pte 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
    18963
  • 사례 시작날짜
    2015-08-12
  • 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: Leica Microsystems Pty Ltd, New Zealand Branch, 3/33 Spartan Road, Takanini, Auckland 2105
  • 원인
    The manufacturer recently became aware that these devices have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm not to function correctly in the case of an instrument failure., if there is an instrument failure during processing and the remote alarm is relied upon then the missing alarm signal could lead to suboptimal quality tissue processing. in some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.
  • 조치
    Product to be modified

Device

Leica ASP 200S Analyser

Manufacturer

Leica Instruments Singapore Pte Ltd