Events

Rappel de Freedom Healthcare Quad Walkers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gainsky 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-2017-RN-01130-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-15
  • 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-2017-RN-01130-1
  • 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
    The sponsor has become aware of a fault where the front right wheel of specific quad walkers has either worked loose, or the wheel has sheared off the frame of the walker. when the wheel shears off, the wheeler becomes unstable and the user may become unsteady on their feet and lose their balance.
  • Action
    1. Users are to find the information sticker on the walker and look at the batch number stamped on the sticker. Photographs of the location of the sticker to assist customers will be provided with the customer letter. Verify the unit is affected stock. 2. Take the walker to the place of purchase where you will be offered a replacement walker or a refund of your purchase price. 3. A representative will contact distributors to arrange to recover any stock of the defective products held and replace them with sound items. For further information, please see https://www.tga.gov.au/alert/freedom-healthcare-quad-walkers

Device

Freedom Healthcare Quad Walkers
  • Modèle / numéro de série
    Freedom Healthcare Quad WalkersModel Numbers: BRO209 and BRO199Batch Numbers: FHFHCBR13 and FHFHCBR15Manufactured in June 2016 and October 2016 ARTG Number: 137219
  • Manufacturer
    Gainsky Pty Ltd

Manufacturer

Gainsky Pty Ltd