Events

Rappel de STORM SERIES 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
    30202
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-01-09
  • 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 potential wiring pinch point involving invacare fdx tdx series and storm series power wheelchairs with 20"-24" width configurations with formula cg recline seating system (i.E. tilt/recline tilt/recline/elevate or recline only) and a conventional style back. there is a possibility that if the slack in the wires is not routed and secured correctly and with flexing of the back pan under the user's weight the headrest knob or clamp bracket may pinch damage or cut the wire creating a hazard. smoking sparking burning or fire may occur if any wire in this area is repetitively pinched at the same location over a period of time. not all impacted chairs are expected to have slack in the wiring that is not routed and secured correctly.

Device

STORM SERIES POWER WHEELCHAIR
  • Modèle / numéro de série
    Model Catalog: 3GTQ3-MCG (Lot serial: CONTACT MFG); Model Catalog: 3GTQ3-CG (Lot serial: CONTACT MFG); Model Catalog: 3GTQ-MCG (Lot serial: CONTACT MFG); Model Catalog: 3GTQ-CG (Lot serial: CONTACT MFG); Model Catalog: 3GSEAT-CG (Lot serial: CONTACT MFG); Model Catalog: 3GRX-CG (Lot serial: CONTACT MFG); Model Catalog: 3GAR-CG (Lot serial: CONTACT MFG); Model Catalog: TDXSRSEAT (Lot serial: CONTACT MFG); Model Catalog: TDXSR-MCG-HD (Lot serial: CONTACT MFG); Model Catalog: TDXSR-MCG (Lot serial: CONTACT MFG); Model Catalog: TDXSR-CG-HD (Lot serial: CONTACT MFG); Model Catalog: TDXSR-CG (Lot serial: CONTACT MFG); Model Catalog: FDX-CG (Lot serial: CONTACT MFG); Model Catalog: TDXSP-MCG-GT (Lot serial: CONTACT MFG); Model Catalog: TDXSP-MCG (Lot serial: CONTACT MFG); Model Catalog: TDXSP-CG-GT (Lot serial: CONTACT MFG); Model Catalog: TDXSP-CG (Lot serial: CONTACT MFG); Model Catalog: FDX-MCG (Lot serial: CONTACT MFG); Model Catalog: TDXSPSEAT (Lot serial: CONTACT MFG)
  • Description du dispositif
    STORM SERIES POWER WHEELCHAIRS
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION