Events

Rappel de Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Otto Bock 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-2014-RN-00458-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-04-23
  • 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-2014-RN-00458-1
  • 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
    During the course of on-going market observations the front caster fork complaint rate of the three wheelchairs has increased. a detailed analysis of the reports shows that the caster forks may, in unusual circumstances, break when repeatedly driven over or against street curbs.
  • Action
    Ottobock Healthcare is replacing the caster fork on all affected A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs. Product corrections are to be carried out by the wheelchair dealer. For more details, please see http://www.tga.gov.au/safety/alerts-device-ottobock-power-wheelchairs.htm .

Device

Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between...
  • Modèle / numéro de série
    Otto Bock A200 Power Wheelchair, SKIPPI and SKIPPI PLUS Power Wheelchairs Units delivered between 20 June 2011 and 8 March 2013ARTG Number: 177246
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd