Events

Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge Australia 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-2016-RN-01216-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-09-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01216-1
  • 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 manufacturer has become aware that due to a software issue, if the compressed air supply of the machine is lost right before or during product supply (dlc detergent, aperlan poka-yoke agent a/b disinfectant), and after cycle start, and not re-established before cycle end, the machine does not launch or complete the product supply when reprocessing a scope. as a result, no alarm is triggered.
  • 조치
    Getinge is advising users of interim instructions to follow. Users are advised to carefully examine the printer ticket at the end of each reprocessing cycle to ensure there are 3 lines printed for DLC weight, Disinfectant A and B weights are OK. A software upgrade will be implemented as a permanent correction. This action has been closed-out on 20/02/2017.

Device

Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)
  • 모델명 / 제조번호(시리얼번호)
    Getinge ED-FLOW AER, ED-FLOW SD AER (Automated washer-disinfector for endoscopes)Model Number: 01280010Serial Numbers: 4H120383, 4H120384ARTG Number: 228574
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd