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U.S. Department of Health and Human Services

Class 2 Device Recall Invacare Storm TDX SP Power Wheelchair with Stability Lock

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  Class 2 Device Recall Invacare Storm TDX SP Power Wheelchair with Stability Lock see related information
Date Initiated by Firm November 27, 2007
Date Posted January 27, 2009
Recall Status1 Terminated 3 on August 01, 2013
Recall Number Z-0930-2009
Recall Event ID 50169
510(K)Number K023589  
Product Classification Powered Wheelchair - Product Code ITI
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.
Code Information 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 07GE000060 07GE004183 07CE002612 07CE007711 07FE000069 06JE006574 06IE008343 06JE006264 07GE005530 07GE006874 07GE006876 07HE005361 07HE005604 07BE005561 07DE005076 07EE001318 07AE003548 07EE006996 06HE010436 06JE009097 07BE001104 07BE005147 06JE005455 07AE002036 06LE002631 07BE001120 07CE005290 06IE004481 07EE004971 07BE005138 06HE008573 07CE006299 07CE005278 07AE003012 07HE001772 07FE006661 07FE004822 07EE005196 06KE006599 07CE006357 07FE000071 07DE003169 07GE001975 07GE005160 07EE004621 07HE002829 07EE005171 07FE003581 06LE004873 07BE005760 07BE006222 07DE004798 07EE005174 07AE003013 07AE004640 07DE004804 07GE001370 07IE000113 07IE001335 07GE007317 07HE004214 07HE004755 06KE003402 07FE000862 07EE001092 07EE001096 07FE005137 07GE000043 07DE003993 07GE006521 07HE005492 07HE006451 07FE006907 07GE003515 07FE000884 07GE002441 06LE002012 07DE002120 07EE004631 07GE001131 07HE005654 07BE001323 07HE002619 06JE008362 06JE009104 06IE004485 07EE006021 07GE000062 07GE000804 07HE004743 07HE006180 07HE006181 07CE008189 07DE005062 07AE002034 07DE002290 07FE006901 07FE006918 07FE005903 06HE009622 07FE006908 07GE004925 07GE001374 07FE002714 07BE005356 07BE005148 07FE006275 07GE000793 07FE005889 07EE006011 07HE007050 07GE006526 07AE003737 07CE004835 07BE001117 07IE000105 07GE006944 07HE001767 07AE003552 07DE002487 07FE001077 07GE002442 07HE001213 07HE004477 06LE007225 06LE001325 07EE007012 07FE000023 07EE007013 07DE002497 07DE002496 06JE007421 07EE005407 07GE002243 07FE006383 07GE001977 07GE001981 07HE007035 07GE004171 07GE006948 07GE007323 07GE000066 07GE004906 07GE004905 07EE002509 07FE002202 07GE003777 07HE005265 06IE008338 07GE004995 07CE005784 06IE004749 07EE006611 07FE002713 07BE004937 06KE004473 07FE003584 07HE001452 07AE005911 07FE006064 07GE005902 07HE004469 07HE005260 07GE005874 07HE003344 07HE001455 07CE004833 07FE006063 07CE001573 07IE000960 07IE001328 07FE006065 07EE003205 07DE003991 07EE007019 07EE006604 07FE006913 07GE005166 07HE001073 07HE003716 07FE001072 06LE001322 07AE006937 07CE007185 07CE001560 07EE006997 07DE002280 06KE008637 07FE005117 07GE002232 07FE000876 07GE004918 07GE005891 07GE006759 07EE001330 06IE004748 07FE006066 07FE007537 07HE001450 07AE001605 07CE006302 07AE002038 07BE001328 06LE006735 07CE001570 07CE002605 07CE007697 07DE005255 07CE002608 07CE003326 07DE002129 07DE005413 07FE002881 07FE002441 07GE001973 07IE000405 07IE001340 07GE006752 07HE002608 07HE003063 07HE004226 07EE006255 06JE009103 07DE004594 07CE008940 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and 07EE006271. 
Recalling Firm/
Invacare Corporation
1200 Taylor St
Elyria OH 44035-4190
For Additional Information Contact Carroll L. Martin
Manufacturer 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 2
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 in Commerce 4171 Wheelchairs
Distribution Worldwide Distribution --- including USA and countries of Canada, Australia, Germany, New Zealand and the United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = INVACARE CORP.