Events

Rappel de Karma Wheelchairs Item Name: Flexx(KM-8022)18*18

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Independent Home Care & Surgical Supplies 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-2015-RN-01157-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-25
  • 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-2015-RN-01157-1
  • 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
    Incorrect parts were supplied for karma wheelchairs. the bore diameter of the flexx side frame and front caster mount should be y8 to fit m8 screws. however, the flexx that was provided was y6 on the side frame and y8 on the caster mount. the production line did not realise the problem during production and assembled the caster mount to side frame by m6 screws. since the castor mount has bigger holes (y8), the wheelchair is likely to be wobbly while driving and more seriously, after a few months the m6 screws may fall off from the frame.This action was taken prior to consultation with the tga.
  • Action
    Independent Home Care & Surgical Supplies is contacting users to correct affected units. This action has been closed-out on 11/11/2016.

Device

Karma Wheelchairs Item Name: Flexx(KM-8022)18*18

Manufacturer

Independent Home Care & Surgical Supplies Pty Ltd
  • Source
    DHTGA