Events

Iris Hi Lo Bed(adjustable electric bed) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pride Mobility Products 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-2017-RN-00842-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00842-1
  • 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 tga has determined that the side rails supplied with this bed do not comply with the below listed standard and that there is a resulting risk of patient harm, including but not limited to patient entrapment:iec 60601-2-52:2009: medical electrical equipment - part 2-52: particular requirements for the basic safety and essential performance of medical beds while no safety-related incidents have been reported to date, pride australia has, as a precautionary measure have agreed to undertake a recall for product correction.
  • 조치
    Pride, requests that users immediately remove the existing side rails in the event they are installed on the bed. To enable you to remove the existing side rails, Pride have supplied a leaflet of instructions demonstrating how to remove the side rails, along with the Customer Letter as an attachment. Please follow the instructions given to facilitate this recall action.

Device

Iris Hi Lo Bed(adjustable electric bed)

Manufacturer

Pride Mobility Products Australia Pty Ltd