Events

Tenor without scale (Mobile patient transfer lift) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Huntleigh Healthcare 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-2014-RN-00566-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00566-1
  • 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
    During use, the bolt in the connection between the spreader bar and the lifting arm jig is subjected to mechanical forces, which may lead to breakage. this is due to the design of the connection between spreader bar and lifting arm jig, which in long term use can cause metal fatigue in this part and the formation of micro-cracks in the thread of the bolt. this issue is only related to tenor devices without scales.
  • 조치
    ArjoHuntleigh will arrange for the replacement of the old spreader bar with a new spreader with scales. This action has been closed-out on 12/02/2016.

Device

Tenor without scale (Mobile patient transfer lift)

Manufacturer

Huntleigh Healthcare Pty Ltd