Events

Rappel de Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings)

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-01014-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-15
  • 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-01014-1
  • 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 one complaint where the ceiling bracket 71 has been shipped with an increased size of the center hole.A potentially hazardous situation exists if the ceiling bracket 71 with a larger center hole is used for a concrete ceiling installation since a m8 screw and washer will be used. analysis has shown that if the bracket is mounted with a m8 screw and washer in a concrete ceiling ultra system installation (maximum load of 400 – 500 kg) there is a safety hazard associated with the installation that could potentially cause the system to fall.
  • Action
    Hill-Rom is advising the distributor to inspect stock and quarantine the affected brackets for return. All the affected stock is with the distributor. This action has been closed-out on 10/05/2017.

Device

Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete cei...
  • Modèle / numéro de série
    Ceiling Bracket, Arch 71 White (used for installing Liko patient lifts to wooden and concrete ceilings)Product code: 3102071 ARTG number: 161863
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd