Recall Z-0930-2009 ยท ITI Wheelchair, Powered
Invacare Corporation
Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP, TDXSP-CG, and TDXSP-MCG To provide mobility to a person restricted to a sitting position.
| Date | Jan 27, 2009 (initiated Nov 27, 2007) |
| Status | Terminated |
| Reason | Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings. |
| Root cause | Pending |
| Action | On 11/27/2007 the firm sent Urgent Field Correction Needed recall notification letters and response forms to their customers informing them of the problem. They instructed their customers to immediately inspect and adjust the Stability Lock feature, distribute the enclosed update to the Owner's Manual to all end-users, and return the enclosed response form notifying them that the inspection and/or adjustments have been completed. |
| Quantity | 4171 Wheelchairs |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, Australia, Germany, New Zealand and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023589 | STORM TDX POWER WHEELCHAIR Invacare Corp., Nov 19, 2002 |