Events

Rappel de LIKO SlingBar 350, SlingBar 360, SlingBar Wide 670 and SideBar Standard

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-2013-RN-01059-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-11-21
  • 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-2013-RN-01059-1
  • 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 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.
  • Action
    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
  • Modèle / numéro de série
    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