Events

APS EVOTECH Integrated Endoscope Disinfection System 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Advanced Sterilization Products 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
    15928
  • 사례 시작날짜
    2013-12-20
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    The manufacturer of evotech® endoscope cleaner and reprocessors (ecr) has discovered that the evotech® ecr may cancel cycles when reprocessing the pentax eg-3670urk flexible endoscope. the pentax eg-3670urk flexible endoscope has been qualified for use with the evotech® ecr, however it cannot currently be processed in the evotech® ecr due to incorrect flow rate parameter programming in the system that is specific to this endoscope. the minimum flow rate has been programmed at levels higher than those required for effective cleaning of this scope which leads to cycle cancellation for error of low flow.
  • 조치
    Software to be upgraded

Device

APS EVOTECH Integrated Endoscope Disinfection System

Manufacturer

Advanced Sterilization Products