Recall of Device Recall Invacare Storm TDX SP Power Wheelchair with Stability Lock

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50169
  • Event Risk Class
    Class 2
  • Event Number
    Z-0930-2009
  • Event Initiated Date
    2007-11-27
  • Event Date Posted
    2009-01-27
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2013-08-01
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered Wheelchair - Product Code ITI
  • 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.
  • 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.

Device

  • Model / Serial
    Serial 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033 07HE004238 07HE005660 07BE001602 07DE002507 07GE004939 07FE006904 07IE000689 07GE001967 07HE001199 07AE002694 07CE001571 07CE001568 06LE004879 07CE005547 07EE001329 07DE003986 07FE004815 07GE005890 07HE003059 07IE000121 07DE005048 07EE004953 07FE005355 07GE001358 07FE001527 07EE005189 07FE000874 07CE006037 07EE001938 07HE001065 07GE005162 07GE005876 07GE006543 07GE006545 07HE001443 07EE005400 07EE000526 07EE000525 06LE002014 06KE001940 07CE006309 07EE006266 07GE002308 07BE001100 07GE006525 07CE003320 07EE006608 07CE006304 07EE003968 07EE005416 07DE001659 07CE008704 07EE001782 07HE003726 06LE003724 07CE006573 06LE002637 07GE001132 07GE003014 07DE006265 07FE006284 07HE007043 07HE007052 07IE000679 07IE000956 07IE001490 07GE005663 07AE003009 07CE002598 07CE005531 07FE006649 07FE006648 07GE001122 06JE005914 06KE000177 07AE005131 07CE005546 07GE001379 07GE000806 07DE003835 07EE002988 07EE004479 07FE007291 07HE001203 07HE001222 07HE003747 07HE006196 07HE006201 07HE006202 07HE006762 07GE006741 07HE002310 07HE005264 07IE001320 07CE003805 07DE005065 07FE006268 07HE001769 07HE007042 06KE000175 07BE001829 07FE007272 07GE003004 07GE004172 07HE000006 07HE002623 06KE005841 07AE002247 07AE006318 07BE004731 07DE003171 07BE004730 07AE003729 07GE000034 07DE002285 07DE001643 07EE001326 07HE005657 07CE006570 07EE006615 07HE001936 07IE000948 07GE006528 07AE006102 07BE005143 07CE002388 07CE008691 06JE007828  07DE001931 07FE007551 07GE000061 06JE007827 07FE004470 07FE006276 06JE004204 07GE007322 07GE007328 06JE004203 07FE002697 07CE005538 07DE006049 07FE005121 06LE001535 07FE004811 06LE001727 07GE000042 07HE000010 06IE008344 06LE001333 07HE002309 07FE006269 07DE001639 07FE006249 07IE000961 07FE002867 07AE006942 07CE003325 07GE003017 07GE001972 07EE001101 07FE003599 07DE006264 07HE004992 07BE004727 07CE003321 07DE003814 07CE006301 07EE004600 07AE005126 07FE005891 07GE002230 07GE001366 07GE003006 06LE003282 07AE007350 07BE005144 07BE005358 07DE006261 07FE000028 07FE007279 07FE002432 07HE003745 06LE002634 06KE001939 07BE001112 06HE010691 07DE000741 07IE000124 06IE002116 07BE001830 06HE010435 07BE002271 07DE006461 07HE003061 06KE003983 07EE004974 06IE004479 07FE002433 07CE003616 07FE006895 07HE001055 07DE003396 07EE001483 07GE005658 07GE003001 07GE005155 07EE001089 07CE006017 07BE002030 07HE006458 07FE007288 07GE005909 06LE004869 06LE004868 06LE004871 06LE004870 06LE004662 07BE006478 07GE005434 07GE001126 07HE005497 07GE005651 07CE006298 07CE005529 07CE005532 06LE005162 07EE002512 07FE004482 07HE001763 07HE004976 07HE005641 07FE006061 07CE003329 07DE006047 06LE001505 06LE001506 07EE003225 07DE002116 07EE006040 07HE002700 07HE005603 07CE009281 06JE009098 06LE007038 07DE002489 07HE001056 07GE005877 07FE006920 07GE005000 07AE003726 06KE007253 06LE001691 06KE006598 07EE001587 07FE006396 07FE006767 07HE001439 07HE001438 07GE006627 07IE000494 06JE009096 07EE001923 07HE000024 07HE006183 07IE000374 07IE000378 07IE000380 07GE005436 07CE006300 07DE001387 07DE002123 07FE002198 07GE002228 07FE006259 07GE000788 07FE002192 07FE001522 07FE004808 07DE004600 07HE003067 06LE001723 07GE007325 07HE004217 07HE006444 07IE000107 06LE003281 07HE006748 07HE005272 07IE000137 07GE005165 06JE008688 07AE001009 06HE010678 07FE005356 07FE004817 06KE003404 06KE006905 06KE006916 07BE006226 06IE004482 07EE005409 07EE006610 07HE005271 07BE001828 06JE006329 07CE004019 07FE002197 07EE001765 06LE001724 07CE007193 07FE003586 07EE000535 07EE001929 07FE000034 07GE007334 07HE007041 07GE005641 07GE006737 06JE002581 06KE002879 06LE002011 06LE005910 07AE005121 07AE005122 07BE004924 07CE008930 07DE002486 07GE005640 07DE005403 07BE001108 07GE003003 07GE004908 07CE008942 06IE009764 07DE003823 07EE004619 07DE005072 07EE000006 07GE003510 07FE000882 07GE004912 07CE004841 07CE006038 07DE005075 07FE003600 07FE006072 07FE006916 07HE002616 07HE003737 07HE006166 07FE000866 07DE003826 07GE002249 07FE000870 07BE005368 07GE005903 06HE011336 06LE001721 07CE005792 07AE002040 07GE004926 07GE004927 07HE007055 07FE007285 07FE000008 07GE001968 07CE006310 07GE001360 06LE004001 07DE005425 06HE010672 07EE002979 07HE006173 07GE006750 07DE005050 07GE001361 07HE000009 07HE004229 07IE000951 07IE000682 07IE000687 07GE001129 07GE002423 07GE004174 07HE004232 07DE001638 07BE004077 07GE004178 07FE002871 06JE009100 07FE006251 07AE002246 07FE006655 07HE006303 07HE006304 07HE006305 07HE006306 07HE006307 07HE006308 07HE006309 07HE006310 07HE006311 07HE006312 07HE006313 07HE006314 07HE006316 07HE006317 07HE006318 07HE006319 07HE006320 07HE006321 07HE006322 07HE006323 07HE006324 06LE003998 07FE004819 07GE006760 06JE007097 07FE004821 07EE006617 07HE003069 07HE004742 07HE004984 07HE005498 07FE001078 07HE002825 07HE005491 06IE008348 07GE006751 07FE002865 07GE000039 07HE005647 07BE006785 07CE001562 07FE002440 07DE004603 07CE002080 07BE002272 06IE006809 07HE000033 07HE000034 07HE006190 07HE005002 07HE006470 07HE006756 07AE005912 07AE002473 07FE005139 06KE003131 07CE009277 07BE003595 07AE005610 07EE004960 07FE006286 07HE004991 07HE002622 07CE007191 07HE006462 06LE000184 07FE004478 07FE006273 07GE000046 07FE005127 07GE003771 07FE005142 07HE002321 07HE003055 07FE005116 07DE005256 07CE009278 07FE002712 07EE001094 07DE003994 07HE001445 07HE004464 07HE006200 07EE000005 07EE004597 07EE004947 07GE002233 07GE000792 07EE006254 07GE005154 07DE006465 07GE000053 07FE007281 07EE005187 07HE001054 07HE002294 07HE002304 07HE003719 07EE001090 07DE003830 07HE007031 07BE005759 07EE004944 07FE007269 06IE004762 07EE006260 07DE006469 07FE002437 07GE003022 07EE004639 07GE003778 07HE002298 07HE004221 07HE005253 07HE006171 07HE006204 07GE005889 07CE003804 07HE001463 07HE006461 07CE006571 07CE003323 07DE000593 07DE000592 07EE002505 07HE003718 07IE001325 07DE005253 07GE003754 07EE006001 07FE005126 07GE003509 07FE004475 07HE001775 07HE001787 07HE004481 07HE005273 06LE003479 07DE006462 07HE002301 07FE006911 07HE004468 07GE006529 07BE004072 07FE003825 07BE004925 07CE007694 07CE001558 07DE003166 07EE001319 07FE002693 07AE004641 07AE003014 07BE001598 07CE007703 06LE005753 07DE002502 07BE006487 07CE005289 07CE006027 07EE001332 07FE000029 07FE001529 07FE004468 07GE000068 07FE001523 07GE005159 07FE000013 07GE000798 07GE006941 07HE002319 07HE002844 07HE003345 07HE004457 07HE004979 07HE005258 07HE006182 06JE003899 07FE003820 07FE005902 07FE007275 07EE004604 07DE005410 07DE004805 07EE005175 07EE000536 07EE002817 07GE003762 07DE002511 07DE002508 07EE005195 07HE003049 07HE003056 07HE005255 07HE005490 07HE006197 07HE006442 07FE002771 07DE005051 07EE001481 07GE001140 07EE005402 07FE006278 07GE006943 07HE005259 07HE006186 07GE006522 07FE003582 07BE004923 06HE010426 07EE007008 07FE004828 07EE004976 07IE000683 07DE002122 07EE004603 07EE006250 07FE006898 07BE005562 07EE002507 07EE004627 07EE006007 07EE002823 07GE003016 07GE003007 07EE000537 07CE008947 07HE003054 07EE001317 07BE004935 07EE001780 07FE004818 07EE002824 07HE004460 07DE002501 07HE002318 07BE005136 07DE001388 07GE005147 07CE003803 07GE006961 07DE002300 07EE005198 07AE007626 07AE003736 07CE005293 07DE006460 07FE002885 07GE006743 07EE006998 07GE003511 07GE003781 07DE000595 07CE006035 07GE004165 07CE007182 07DE001925 07GE002234 07CE007192 07CE007195 07CE005542 07CE006034 07DE001935 07GE005892 07FE006656 07GE004176 07FE006285 07HE002840 07HE005496 07DE001647 07GE000069 07GE007329 06HE010671 07DE004799  06IE009398 07DE006463 06KE005555 07DE001667 07EE002981 07FE002869 07EE006022 07CE004832 07CE008929 07AE001613 07DE005411 07FE002698 07BE002026 07DE003170 07EE001325 07EE004620 07DE006054 06JE009101 07AE005129 07CE004024 06IE009396 06IE009761 06HE008571  06IE007958 07DE001934 07FE004829 07DE005066 07HE004736 07IE000127 07EE004952 07FE003810 07EE000528 07GE005643 07HE002289 06LE000183 07BE002264 06HE010417 07AE003733 06KE002882 07AE005613 07AE005612 07AE005614 06HE010429 06KE008633 07DE006455 07BE003355 07DE003172 07FE006662 07CE003315 07DE005071 07HE002842 07BE006223 06LE005749 07CE002599 07GE001123 06HE010432 07HE001207 07DE000587 07AE001607 07AE004637 06KE007467 07BE004076 07GE002236 07FE007286 07GE005648 07FE000868 06LE003996 07AE007620 07CE004831 07FE000006 07GE003000 07GE001119 07AE003011 07DE004810 07EE007020 07EE001324 07FE000880 07GE004909 07GE003514 07GE006878 07GE006936 07HE001942 07HE003717 07HE003734 07HE006195 07HE006456 07BE006721 07EE001091 06LE001330 07BE005366 07DE003988 06JE007829 07FE003814 07HE007046 07HE007029 07EE003199 07HE002303 07HE007047 07GE005661 07DE003559 07EE001775 07CE008941 07CE008687 07FE000005 07BE002025 07CE008182 07DE001386 07FE003809 07BE002027 07CE002195 07DE005059 07DE003575 07EE003213 07FE005132 07FE007274 07HE000029 07HE002295 07HE005261 07DE006256 07BE005146 06KE006076 07EE001335 06IE008359 07GE003495, and 07EE006271.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, Australia, Germany, New Zealand and the United Kingdom.
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
  • Source
    USFDA