Events

Cook Aspiration Unit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-2018-RN-00174-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00174-1
  • 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
    A recent design review of the k-mar-5200 aspiration unit, identified that the internal mains wiring does not fully comply with the requirements of the medical electrical equipment standard iec60601-1 edition 3.0. iec60601-1. this standard states that conductors and connectors of medical electrical equipment shall be secured or insulated so that accidental detachment shall not result in a hazardous situation. the k-mar-5200 mains wiring is secured, but the mechanism is not considered suitable under iec60601-1.To date, no harm has been reported as a result of this issue.
  • 조치
    Cook Medical is advising that they will be replacing the mains wiring for affected each unit. An authorised service agent will contact users to arrange for impacted devices to be corrected. In the interim, Cook Medical recommends that a residual current device (RCD), also known as a ground fault circuit interrupter (GFCI), ground fault interrupter (GFI), or an appliance leakage current interrupter (ALCI) is fitted to the mains electricity supply to mitigate the risk of a hazardous situation.

Device

Cook Aspiration Unit
  • 모델명 / 제조번호(시리얼번호)
    Cook Aspiration Unit Part Numbers: K-MAR-5200, K-MAR-5200-USGlobal Product Numbers: G49275, G51067ARTG Number:156032(William A Cook Australia - Suction unit, electric powered)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd