Events

Minstrel Patient Transfer Lift with Scale 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-00790-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-07-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00790-1
  • 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
    Arjohuntleigh received a limited number of reports where the bolt under the scale unscrewed from the scale. this issue may cause the spreader bar bolt to unscrew from the scale and detach the spreader bar from the device.
  • 조치
    ArjoHuntleigh would like to provide the following options to ensure continued safety and performance of your Minstrel Lift. Option 1: The Minstrel Lift devices are close to their intended 10-year lifetime and ArjoHuntleigh would like to offer our customers a trade-in discount to purchase a new Minstrel ArjoHuntleigh patient transfer lift. Option 2: An ArjoHuntleigh Service Technician will install a new scale with added locking features, to your existing Minstrel Lift, free of charge. If Option 2 is chosen, ArjoHuntleigh want to remind you that the Minstrel lift is near its intended 10-year lifetime and it should not be used past its lifetime, including installation of the new scale.

Device

Minstrel Patient Transfer Lift with Scale
  • 모델명 / 제조번호(시리얼번호)
    Minstrel Patient Transfer Lift with Scale Serial Numbers: MPLAT0502W1403, MPLAT0502W1404, MPLAT0504W1518, MPLAT0504W1519 ARTG number: 200785
  • Manufacturer
    Huntleigh Healthcare Pty Ltd

Manufacturer

Huntleigh Healthcare Pty Ltd