Events

Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hill-Rom 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-01014-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01014-1
  • 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
    Hill-rom has received one complaint where the ceiling bracket 71 has been shipped with an increased size of the center hole.A potentially hazardous situation exists if the ceiling bracket 71 with a larger center hole is used for a concrete ceiling installation since a m8 screw and washer will be used. analysis has shown that if the bracket is mounted with a m8 screw and washer in a concrete ceiling ultra system installation (maximum load of 400 – 500 kg) there is a safety hazard associated with the installation that could potentially cause the system to fall.
  • 조치
    Hill-Rom is advising the distributor to inspect stock and quarantine the affected brackets for return. All the affected stock is with the distributor. This action has been closed-out on 10/05/2017.

Device

Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete cei...
  • 모델명 / 제조번호(시리얼번호)
    Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings)Product code: 3102071 ARTG number: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd