Events

EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty 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
    RC-2013-RN-00319-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-04-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00319-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Johnson & johnson medical is issuing a product correction for the evotech endoscope cleaner and reprocessor system after receiving reports of smoke emanating from the system and upon further investigation has discovered that a circuit board malfunction may occur in the channel control manifold sub-assembly. this failure can potentially cause the following outcomes for the cycles: 1. full reprocessing cycle (cleaning and hld) - if this issue were to occur while running a full automated cleaning and high level disinfection (hld) cycle, there is potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes, 2. hld-only cycle - if this issue were to occur during reprocessing of endoscopes qualified for the hld only cycle, there is potential for an inadequate amount of high-level disinfectant solution to be sent through some endoscope channels.
  • 조치
    Johnson & Johnson Medical Pty Ltd is providing the users with the instructions to prevent the issues from occurring.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
  • 모델명 / 제조번호(시리얼번호)
    EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)Product number: 50004ARTG: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd