Events

EVOTECH Endoscope Cleaner and Reprocessor (ECR) 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-01344-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01344-1
  • 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
    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
    Johnson & Johnson Medical is advising users with the Pentax EG-3670URK scope to manually clean and undertake a high level of disinfection prior to use. The EVOTECH ECR can continue to be used in accordance with the user guide for all other endoscopes that have been qualified and validated. A software update will be implemented as a permanent fix.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR)
  • 모델명 / 제조번호(시리얼번호)
    EVOTECH Endoscope Cleaner and Reprocessor (ECR) Part Number: 50004ARTG Number: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd