Liko Universal SlingBar 350, SlingBar 450 and SlingBar 600 (used with Golvo, Uno, LikoLight, Likorall, Multirall and Viking XS/S/M/L mobile patient lifts) 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-00082-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-01-21
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 universal slingbar 350, slingbar 450 and slingbar 600 which can be attached to various liko overhead and mobile patient lifts,complaints have been received that the centre bolt of this sling bar, which connects the bar to the patient lift, has failed during use.The potentially affected sling bars have been produced until may 2014.Analysis has shown that the sling bar is reliable when used as intended with the sling bar level during the lift. however, if the sling bar is not used as intended, the bolt may be weakened. if the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. this hazard could cause potentially minor to catastrophic injuries to a patient.
  • 조치
    Hill-Rom is providing users with a set of instructions to follow to identify if they have an affected sling bar. This inspection should be carried out at regular intervals. Hill-Rom is providing a replacement sling bar to users who have an affected sling bar free of charge. This action has been closed on 26/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Liko Universal SlingBar 350, SlingBar 450 and SlingBar 600 (used with Golvo, Uno, LikoLight, Likorall, Multirall and Viking XS/S/M/L mobile patient lifts)Universal SlingBar 350Part Numbers: 3156074, 3156084 and 3156094Universal SlingBar 450Part Numbers: 3156075, 3156085 and 3156095Universal SlingBar 600Part Numbers: 3156076 and 3156086Serial Numbers: 1200101 to 1370151ARTG Number: 188199
  • Manufacturer

Manufacturer