| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00356-1 |
| Product Name/Description |
Invacare 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
Models:
TDX Series: TDXSP, TDXSP-AUS, TDX SR-AUS & TDX SR
Storm Series: 3GTQ-MCG, STORM TORQUE, STORM TORQUE-AUS, RANGERX, 3GRX-CG, ARROW 3G & 3GAR-TS
Multiple serial numbers
Manufactured from October 1, 2006 - July 31, 2014
ARTG number: 160385 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Invacare has recently identified a potential pinch point affecting the wiring of the listed power wheel chairs. 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. Invacare has received one complaint and there have not been any reported events involving injury associated with this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Dealers are advised to identify wheelchair owners and notify them of this issue and proposed actions using the consumer letters provided by Invacare. Dealers are also advised to contact their respective customers to schedule an appointment to inspect the potentially impacted power wheelchair as soon as possible. A visual inspection of the wiring shall be conducted for each impacted chair and where required the wiring will be (corrected) routed and secured in accordance with the Power Wheelchair Wiring Guide provided to dealers. For more details, please see http://www.tga.gov.au/alert/invacare-tdx-and-storm-series-power-wheelchairs . This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 460 460 - Invacare Support Line |