Events

Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Beckman Coulter 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
    20489
  • 사례 시작날짜
    2016-08-09
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • 원인
    Manufacturer has received and confirmed a report of a fire within the stainer module of a customer's dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module's methanol bath. beckman coulter is initiating this corective action to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire.
  • 조치
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
  • 모델명 / 제조번호(시리얼번호)
    Model: 775222, Affected: , Software version: all software revisions
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc