Events

CellaVision DI-60 version 6.0.1 and 6.0.2 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Sysmex Corporation 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
    22936
  • 사례 시작날짜
    2018-05-07
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • 원인
    A bug has been discovered in versions 6.0.1 and 6.0.2 of cellavision di-60 software where some comments are not sent to lis., the problem occurs only when a specific workflow involving multi-slide is selected as described below:, a)multiple slide workflow is selected (i.E. > 1 slide is analyzed on a sample no.), and, b)operator adds a comment on the last slide in the wbc, rbc or plt comment boxes in the di-60 sw after it has been signed/reported.
  • 조치
    Software to be upgraded

Device

CellaVision DI-60 version 6.0.1 and 6.0.2
  • 모델명 / 제조번호(시리얼번호)
    Model: All on sw version 6.0.1 and 6.0.2., Affected:
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation