Events

Rappel de 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)

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-2016-RN-00082-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-01-21
  • 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-2016-RN-00082-1
  • 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 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.
  • Action
    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

Liko Universal SlingBar 350, SlingBar 450 and SlingBar 600 (used with Golvo, Uno, LikoLight, Liko...
  • Modèle / numéro de série
    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
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd