Events

Recall of STORM SERIES POWER WHEELCHAIR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INVACARE CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30202
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-09
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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)
  • Product Description
    STORM SERIES POWER WHEELCHAIRS
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION