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
    43878
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-06-08
  • 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
    The post fuse assemblies on the affected models of invacare power wheelchairs could potentially be defective in a manner that would result in the fuse not operating as intended (blowing) in the event of future damage or faults within the main wiring harness. while each battery is equipped with a fuse that alone would provide the intended safety function there is a potential risk of fire and serious injury should both fuses be defective.

Device

POWER WHEELCHAIR
  • Modèle / numéro de série
    Model Catalog: TDXSR-MCG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSR-CG-HD (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSR-CG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FDX-MCG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FDX-CG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: FDX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSR (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSPBASE (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-MCG-GT (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-MCG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-CG-GT (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: TDXSP-CG (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: N/A (Lot serial: )
  • Description du dispositif
    INVACARE POWER WHEELCHAIR
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION