Events

Rappel de Invacare Power Wheelchairs with MK6i Driver Controls

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Invacare Corporation.

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
    15257
  • Date de mise en oeuvre de l'événement
    2015-01-30
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Invacare NZ Ltd, 4 Westfield Place, Mt Wellington, AUCKLAND
  • Cause
    The manufacturer has identified a quality issue relating to specific models of power wheelchair controller that could result in the following problems:, 1. the chair may slow down relative to the commanded speed and not recover, driving at a reduced speed, or, 2. the chair may slow down relative to the commanded speed and then recover, creating an unintended acceleration.
  • Action
    Product to be modified

Device

Invacare Power Wheelchairs with MK6i Driver Controls
  • Modèle / numéro de série
    Model: , Affected: Manufactured between 1-Oct-2006 and 21-Mar-2013
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation