Events

Liko Viking mobile lifts(Liko Lift devices are intended to lift and/or transfer the patients between floors, beds, chairs, etc, from one position to another.) 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-2015-RN-00893-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00893-1
  • 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 9 complaints where it has been described that the lift arm drifted down suddenly on certain viking mobile lifts. these reports have been connected to users who raise the lift arm assembly manually.The lift arm assembly is intended to only be raised by the actuator (lift motor). if the lift arm assembly is manually raised, the actuator can become damaged and get stuck in the highest position. when the actuator is stuck, the lift cannot be raised or lowered by the lift motor. hill-rom requests customers do not raise the lift arm manually since the lifting actuator can become stuck and/or become damaged.
  • 조치
    Hill-Rom is conducting a correction in two phases. Phase 1 will be this letter and information for you to update the Instruction Guides. Phase 2 will include the physical inspection of potentially affected devices. If there is damage to the actuator consistent with manually lifting, the actuator will be replaced by Hill-Rom.

Device

Liko Viking mobile lifts(Liko Lift devices are intended to lift and/or transfer the patients betw...
  • 모델명 / 제조번호(시리얼번호)
    Liko Viking mobile lifts(Liko Lift devices are intended to lift and/or transfer the patients between floors, beds, chairs, etc, from one position to another.)Affected Models:-Viking MModel 2040035 (S/N 9 200 000 – 9 201 689)Model 2040015 (S/N 7 500 401 – 7 568 899)Model 2040005 (S/N 7 100 101 – 7 200 200)Viking LModel 2040004 (S/N 7 200 201 – 7 300 300)Viking XL or Viking 300 LiftModel 2040003 (S/N 801 301 – 804 999)ARTG Numbers: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd