| Class 2 Device Recall Invacare Storm TDX Power Wheelchair | |
Date Initiated by Firm | March 19, 2007 |
Date Posted | July 04, 2007 |
Recall Status1 |
Terminated 3 on September 27, 2012 |
Recall Number | Z-0966-2007 |
Recall Event ID |
37929 |
510(K)Number | K023589 |
Product Classification |
Power Wheelchair - Product Code ITI
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Product | Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS. |
Code Information |
06JE002273, 06JE002762, 06JE003580, 06JE003583, 06JE003584, 06JE003585, 06JE003597, 06JE003598, 06JE003880, 06JE003890, 06JE004170, 06JE004172, 06JE004178, 06JE004196, 06JE004632, 06JE004640, 06JE005420, 06JE005421, 06JE005864, 06JE005870, 06JE005871, 06JE005879, 06JE005885, 06JE006254, 06JE006277, 06JE006599, 06JE006603, 06JE006612, 06JE007087, 06JE007393, 06JE007396, 06JE007403, 06JE007408, 06JE007818, 06JE008028, 06JE008311, 06JE008322, 06JE008324, 06JE008329, 06JE008330, 06JE008332, 06JE008350, 06JE008670, 06JE008678, 06JE009028, 06JE009031, 06JE009039, 06JE009040, 06JE009042, 06JE009060, 06JE009062, 06JE009076, 06KE000147, 06KE000149, 06KE001924, 06KE001933, 06KE002243, 06KE002264, 06KE002265, 06KE002267, 06KE002270, 06KE002851, 06KE002853, 06KE002858, 06KE002862, 06KE003116, 06KE003379, 06KE003381, 06KE003386, 06KE003612, 06KE004451, 06KE004454, 06KE004455, 06KE004467, 06KE004854, 06KE005538, 06KE005826, 06KE006063, 06KE006065, 06KE006333, 06KE006613, 06KE006876, 06KE006877, 06KE006886, 06KE006894, 06KE007257, 06KE007282, 06KE007294, 06KE007450, 06KE007684, 06KE007686, 06KE007689, 06KE008610, 06KE008611, 06LE000170, 06LE000173 06LE001305, 06LE001313, 06LE001527, 06LE001694, 06LE001696, 06LE001697, 06LE001705, 06LE001998, 06LE002608, 06LE003258, 06LE003261, 06LE003267, 06LE003268, 06LE003462, 06LE003466, 06LE003987, 06LE004643, 06LE004650, 06LE004846, 06LE004857, 06LE005143, 06LE005144, 06LE005148, 06LE005152, 06LE005154, 06LE005732, 06LE005895, 06LE006012, 06LE006013, 06LE006024, 06LE006704, 06LE006707, 06LE006709, 06LE007018, 06LE007210, 06LE007358, 06LE007371, 06LE007379, 06LE007387, 06LE007393, 06LE007397, 06LE007403, 06LE007404, 07AE000983, 07AE001149, 07AE001180, 07AE001326, 07AE001327, 07AE001334, 07AE001594, 07AE001595, 07AE002009, 07AE002013, 07AE002223, 07AE002225, 07AE002229, 07AE002400, 07AE002404, 07AE002670, 07AE002683, 07AE002990, 07AE003522, 07AE003700, 07AE003712, 07AE003713, 07AE003716, 07AE004618, 07AE005103, 07AE005337, 07AE005339, 07AE005340, 07AE005341, 07AE005586, 07AE005593, 07AE005597, 07AE005886, 07AE005887, 07AE005895, 07AE006089, 07AE006303, 07AE006308, 07AE006314, 07AE006927, 07AE006930, 07AE007089, 07AE007090, 07AE007091, 07AE007092, 07AE007103, 07AE007105, 07AE007113, 07AE007114, 07AE007326, 07AE007327, 07AE007331, 07AE007334, 07AE007598, 07AE007606, 07AE007607, 07AE007611, 07AE007612, 07BE001073, 07BE001076, 07BE001077, 07BE001078, 07BE001082, 07BE001093, 07BE001303, 07BE001309, 07BE001310, 07BE001578, 07BE001585, 07BE001806, 07BE001810, 07BE002005, 07BE002014, 07BE002015, 07BE002253, 07BE002254, 07BE003336, 07BE003337, 07BE003569, 07BE003574, 07BE003582, 07BE003584, 7BE003585, 07BE004719, 07BE004907, 07BE004913, 07BE004916, 07BE006332. |
Recalling Firm/ Manufacturer |
Invacare Corporation 1 Invacare Way PO Box 4028 Elyria OH 44035
|
For Additional Information Contact | Larry Smith 440-329-6000 |
Manufacturer Reason for Recall | Software error may permit the chair to recline too far. |
FDA Determined Cause 2 | Other |
Action | The recalling firm sent a recall letter dated March 19, 2007. The recalling firm also posted information regarding the recall on their website. |
Quantity in Commerce | 227 devices |
Distribution | Nationwide and Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = ITI
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