Events

Rappel de POWER WHEELCHAIR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada 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
    133480
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-10-02
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Invacare has recently identified a supplier quality issue involving the electrical component of invacare spj+ joysticks and invacare mk6i driver controls (excluding all asl sip-n-puff and switch control systems) on some invacare power wheelchair models. the defect may result in the power wheelchair slowing down relative to the commanded speed and then recovering creating an unintended acceleration. the unintended acceleration due to this defect has resulted in a consumer's power wheelchair running into objects which has led to four confirmed minor injuries which included bruising pinched fingers and pinched hands.

Device

POWER WHEELCHAIR
  • Modèle / numéro de série
    Model Catalog: >10 NUMBERS CONTACT MFG (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    POWER WHEELCHAIRS
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION