Recall Z-0930-2009
Invacare Corporation · initiated November 27, 2007
Product
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.
Codes / lots: Serial Numbers: 07EE006037 07GE001214 07GE005740 07HE003498 06JE003608 07CE002600 07DE002131 07GE004997 07GE004998 07GE006523 07AE005120 07CE002390 06IE000118 07FE004477 07EE006245 07BE001102 07BE001317 07BE001318 07CE002595 07EE001795 07FE007661 07FE007659 07FE001517 07GE000030 07EE006036 07GE003396 07HE001436 07HE002698 07EE001586 06LE003477 07BE003359 07HE006445 07HE001075 06LE003480 07FE006897 07DE002127 07DE005069 07GE005156 07GE006527 07GE006536 07FE007531 07GE005875 06HE010677 07DE003566 07AE001341 07DE002490 07EE004963 07FE006900 07DE002284 07EE006259 06HE010682 07HE005502 07FE003815 07AE006319 07BE001333 07BE003357 07DE002500 07EE006262 07FE007283 07GE005158 07HE002851 07HE004228 07HE006761 06JE001557 07EE001484 07BE006828 07DE001930 07FE007282 07GE001382 07GE005171 06LE006034 06HE008565 07EE006269 07FE002703 07BE003353 07DE001641 07EE001928 07GE004167 07EE000542 07GE003500 07FE004471 07GE003231 07GE004181 07EE006272 07GE004169 07EE001939 07IE000138 07IE000705 07HE001768 07HE006179 07HE006185 07EE004942 07GE001142 07GE006524 07HE002308 07HE002828 07HE003051 07EE004629 07EE002818 07BE001123 07HE004998 07GE006742 07CE008701 07BE003358 06JE003901 07AE001010 07BE006722…
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.
FDA-determined cause: Pending
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.
Details
- Recall number
- Z-0930-2009
- Initiated
- November 27, 2007
- Posted by FDA
- January 27, 2009
- Terminated
- August 1, 2013
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 4171 Wheelchairs
- Distribution
- Worldwide Distribution --- including USA and countries of Canada, Australia, Germany, New Zealand and the United Kingdom.
- Recalling firm
- Invacare Corporation, Elyria, OH