Consumers and health professionals are advised that Invacare, in consultation with the TGA, has initiated a recall for product correction of certain configurations of its TDX and Storm series power wheelchairs.
It has been identified that there is a potential pinch point for the wiring in these models if they have certain configurations with powered recline functionality and a conventional back (see below for a list of affected models and serial numbers). In these devices, if the slack in the wiring is not routed and secured correctly, it can become pinched, damaged and/or cut.
If this happens, with the wiring being pinched repetitively in the same location, it can lead to smoking, sparking, burning or fire.
Please note that not all models in these configurations will have slack in the wiring that is not routed or secured correctly, and therefore not all of these wheelchairs will experience this problem.
To address this issue, Invacare is writing to its distributors with instructions to contact affected users and arrange inspection of the wiring for all potentially affected wheelchairs. The distributor will then correct the problem if identified.
The wheelchairs affected by this recall action were manufactured between 1 October 2006 and 31 July 2014.
Affected models are:
| TDX series | Storm series |
|---|---|
| TDXSP | 3GTQ-MCG |
| TDXSP-AUS | STORM TORQUE |
| TDX SR-AUS | STORM TORQUE-AUS |
| TDX SR | RANGERX |
| 3GRX-CG | |
| ARROW 3G | |
| 3GAR-TS |
Affected serial numbers are:
| 08HE000060 | 09AE005327 | 10HE000072 | 11IE001400 |
| 08HE002245 | 09EE000048 | 10HE004004 | 11JE002736 |
| 08HE005009 | 09FE005586 | 10KE004942 | 11LE001678 |
| 08IE004246 | 09GE004023 | 10LE003140 | 12CE006029 |
| 08IE004660 | 09HE001043 | 10LE003464 | 12FE000604 |
| 08KE003385 | 09JE002975 | 11AE001740 | 12FE001011 |
| 08LE000930 | 09AE005327 | 11DE001327 | 12IE002787 |
| 09AE004382 | 10CE000062 | 11EE002579 | 12LE002731 |
As of 23 April 2015, there has been one complaint of this problem. There have been no reports of injuries associated with this issue.
Information for consumers
Affected users should be contacted by the distributor from whom the device was purchased.
If you or someone you care for use an Invacare FDX, TDX or Storm series power wheelchair you wish to confirm whether or not your device is affected by this recall, check its serial number. The locations of the serial numbers for the different models are:
- TDXSP - inside of right rear swing arm and on the left side of the battery box
- TDXSR - inside of right rear swing arm and on the left side of the battery box
- Storm - on the rear of the frame - right side.
If you have any concerns or questions about this issue, contact the distributor or call Invacare on 1800 460 460.
Information for health professionals
Please be aware of the above issue and advise patients accordingly if they seek advice.
Consider reassuring these patients that, to date, there have been no reports of injuries associated with this issue. Advise them to call Invacare on 1800 460 460 if they continue to have any questions or concerns.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.