Events

Rappel de Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Permobil Australia.

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-01185-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-10-11
  • 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-01185-1
  • 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
    Permobil has been advised of a potential failure of the top plate in which the seating system separates from its base. the top plate is a component that connects the seating system of the wheelchair to the base by a series of welds. the consequences of a complete failure of the top plate assembly would result in the chair user and the seating system falling from the base leading to a potential injury. out of 71 cases reported to the us fda, 3 serious injuries occurred (2 broken bones and 1 laceration).
  • Action
    Permobil will contact the end users to arrange for service repair kit to be delivered and perform the repair as a permanent correction. For further information, please see https://www.tga.gov.au/product-recall/permobil-powered-wheelchairs-corpus-ii-seating-system

Device

Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)
  • Modèle / numéro de série
    Corpus Powered Wheelchairs(with fixed seat and elevator inner tubes)Model: C300 Corpus IISerial Numbers: 2537002437, 2537002471, 2537002476, 2537002514, 2537002746, 2537002891 and 2537002956Model: C350 Corpus IISerial Number: 43203511Model: C500 Corpus IISerial Number: 15702655 Model: C500 Corpus II LRSerial Numbers: 2557000160 and 2557000185ARTG Number: 224603
  • Manufacturer
    Permobil Australia

Manufacturer

Permobil Australia