Events

LIKO SlingBar 350, SlingBar 360, SlingBar Wide 670 and SideBar Standard 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-2013-RN-01059-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01059-1
  • 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 become aware of a potential safety issue related to the slingbar 350, slingbar 360, slingbar wide 670 and sidebar standard, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver, or bystander could result from tripping or otherwise falling in to the sling bar, typically while the lift is parked or stored when not in use. the sling hook on the end of the sling bar could pierce a body structure, such as the head, shoulder, or groin.
  • 조치
    Hill-Rom is providing replacement sling bars to mitigate the issue. This action has been closed-out on 27/01/2016

Device

LIKO SlingBar 350, SlingBar 360, SlingBar Wide 670 and SideBar Standard
  • 모델명 / 제조번호(시리얼번호)
    LIKO SlingBar 350, SlingBar 360, SlingBar Wide 670 and SideBar StandardProduct Numbers: 3156015, 3156002, 3156008, 3156004, 3156013, 3156012, 3156017 or 3156011Distributed between April 1998 and May 2008
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd