Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP, TDXSP-CG, and TDXSP-MCG To provide mob
FDA device recall Z-0930-2009 · posted 2009-01-27 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Pending
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 4171 Wheelchairs
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Australia, Germany, New Zealand and the United Kingdom.
- Date initiated
- 2007-11-27
- Date posted
- 2009-01-27
- Date terminated
- 2013-08-01
- Location
- Elyria, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STORM TDX POWER WHEELCHAIR (K023589) | Invacare Corp. | 2002-11-19 |