Events

Rappel de 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.)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Hill-Rom Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00893-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-09-10
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00893-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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