Events

Rappel de Birdie, Birdie Compact and Flamingo Lifters (Patient Lifters)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Invacare Australia 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-2012-RN-00681-3
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-07-20
  • 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-2012-RN-00681-3
  • 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
    Issue 1: the carabineer used to attach the spreader bar to the lifter may show some wear in the case of intensive or severe use. issue 2: during operation by customers, the spreader bar may unintentionally unhook from the carabineer.
  • Action
    Issue 1: Invacare has informed that they will check and replace the carabineer if the thickness of its sections measures less than 6mm. Issue 2: Invacare has developed retrofit kits and are intending to address this issue by reworking all the affected units.

Device

Birdie, Birdie Compact and Flamingo Lifters (Patient Lifters)
  • Modèle / numéro de série
    Birdie, Birdie Compact and Flamingo Lifters (Patient Lifters)All Model NumbersARTG Number: 166395
  • Manufacturer
    Invacare Australia Pty Ltd

Manufacturer

Invacare Australia Pty Ltd