Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchair...
FDA Device Recall #Z-1139-2015 — Class II — January 15, 2015
Recall Summary
| Recall Number | Z-1139-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 15, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Invacare Corporation |
| Location | Elyria, OH |
| Product Type | Devices |
| Quantity | 525 |
Product Description
Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configurations with power recline seating system and a conventional style back.
Reason for Recall
If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users weight may cause the headrest knob or clamp bracket to pinch, damage or cut the wire. Smoking, sparking, burning or fire may occur if a wire is repetitively pinched at the same place.
Distribution Pattern
Worldwide Distribution-US (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada and Australia.
Lot / Code Information
Model # 3GAR-CG 3GRX-CG 3GSEAT-CG (only for CGTRK & CGR2TK) 3GTQ-CG 3GTQ-MCG 3GTQ3-CG 3GTQ3-MCG. Serial numbers for all models 11KE003137, 11LE003215, 10LE000825, 10JE000783, 08GE001643, 10HE002685, 10HE000921, 12DE000966, 12IE003985, 11KE001216, 07JE005091, 11CE002223, 10HE004991, 11DE002513, 11EE001617, 11AE001071, 09LE002681, 07KE001564, 07GE004941, 08CE002502, 11KE003316, 08HE005195, 08IE002697, 10DE000685, 08IE003493, 10BE002355, 10DE000562, 12IE003063, 12FE004399, 09BE002547, 10DE002382, 08KE000351, 08AE004060, 12JE000192, 12KE001805, 10EE003295, 12KE002002, 11HE002277, 12CE002659, 08EE001584, 09DE003466, 13HE000343, 10HE001917, 11GE003762, 12CE003242, 12JE003316, 08LE004865, 07JE005908, 09HE001839, 08CE001894, 11JE001054, 09FE001441, 08DE000845, 10CE000589, 08BE004611, 10BE002921, 07DE001356, 12DE002032, 09HE004671, 08IE001598, 10KE001144, 08KE004205, 10HE005507, 10HE000564, 12DE003808, 10HE001166, 09DE002092, 11DE004535, 09CE000330, 08HE003225, 12JE001743, 12GE001756, 11FE003542, 07LE004648, 12BE002035, 10BE002352, 09EE003805, 08GE004760, 12GE002328, 12AE005461, 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10KE005252, 09CE002995, 09GE003570, 10GE001670, 07EE005416, 08FE000694, 12EE003636, 11FE003756, 10GE000988, 09JE002220, 12EE001227, 08HE004350, 08DE002290, 12GE002462, 12GE001512, 07KE004536, 09KE001439, 11EE000538, 08JE000306, 10EE000220, 12KE003523, 07GE006763, 08GE003067, 09KE003337, 11DE000628, 10CE002484, 11LE000361, 09GE000037, 08LE002667, 09CE000579, 09KE003779, 12FE002948, 10IE000063, 07KE003261, 09AE001728, 11AE003853, 07FE007547, 09KE004023, 12IE000607, 10JE003184, 08GE004133, 09AE002735, 11BE004196, 07FE007553, 09LE001658, 13JE000076, 10KE003922, 10CE004658, 12CE000920, 11HE001449, 08DE000826, 09LE004867, 13KE000059, 11AE003034, 11CE005170, 12EE001032, 12GE001345, 14DE000608, 09LE004679, 07IE004198, 11BE000957, 11DE004132, 12KE001417, 12HE000671, 07EE003824, 10BE003526, 10EE003002, 12GE000614, 11LE001374, 09LE000605, 12IE002291, 08EE003351, 10DE000561, 10HE004673, 13JE000417, 08CE001890, 10DE001885, 12DE003522, 11BE003755, 10EE002431, 08JE004949, 11EE002081, 08DE004902, 10DE001882, 10GE002862, 11IE002996, 10FE002964, 10HE005693, 08HE002897, 08JE003347, 10EE000435, 07FE005872, 07KE004489, 10FE005007, 12HE001241, 09LE001661, 09FE002367, 10FE000406, 07HE001218, 11LE003443, 10KE001653, 09JE000344, 11KE003753, 09GE002843, 10FE003512, 07GE004185, 08CE001642, 11AE003856, 10FE000401, 12KE001246, 09IE004191, 10IE001556, 08JE002896, 08CE003637, 11IE002836, 08FE000888, 13EE000893, 09IE004190, 10HE004948, 09FE005628, 08EE000044, 12LE001956, 08IE003978, 08JE002061, 09IE004160, 11IE002355, 09LE003295, 08EE000704, 07FE002771, 09DE003666, 09DE004395, 11LE002884, 11LE000371, 10DE001356, 07GE006960, 07KE004386, 11GE004348, 09JE003515, 13AE001255, 11KE001951, 10EE000022, 12DE003740, 08GE002534, 11HE001821, 12GE003064, 06JE007067, 12AE002620, 10KE001127, 13EE000352, 11CE004930, 08JE001340, 08AE001076, 09BE003022, 11JE003636, 09CE003230, 09AE003736, 14GE000110, 10FE001143, 09IE004747, 07GE005170, 12GE003063, 10AE002611, 08HE001118, 08HE002232, 11BE004402, 09GE000477, 08EE001585, 11IE000780, 11CE002260, 08JE000505, 09IE002864, 11CE002715, 09FE003743, 08EE001791, 11FE001615, 08HE003523, 10AE001519, 09LE000562, 11EE002525, 09FE003778, 08LE002969, 12IE000463, 10BE003920, 11AE003037, 08DE002714, 12JE000361, 09LE000017, 08LE002957, 10BE000579, 10GE002444, 11DE002251, 11EE000914, 11BE002624, 13HE000402, 09KE000603, 12KE001092, 13DE000746, 11EE001858, 11GE001897, 10BE001504, 09DE005076, 11JE000499, 13AE000314, 08EE004884, 13FE000683, 09JE001275, 11HE003380, 11IE000305, 10LE002312, 12FE001794, 12DE003958, 07EE001104, 11BE000726, 13DE000552, 11IE001757, 10LE004832, 11IE001081, 12JE000975, 09AE004167, 11BE002398, 12BE000037, 12CE000396, 08EE004136, 12FE001627, 11JE001345, 09FE005142, 10IE005096, 12CE005102, 10DE002337, 13CE000161, 12FE000319, 11KE002804, 09JE001832, 08HE004548, 13BE000586, 12FE003103, 07JE001321, 08BE004616, 11LE001797, 12AE005469, 09EE001156, 07FE002715, 08HE002903, 11FE002752, 08KE003404, 09LE001393, 07KE002513, 07DE003993, 09AE002508, 07HE001464, 12HE003439, 09EE001137, 10FE005569, 07IE004197, 08CE004486, 09CE000591, 08JE000771, 06IE008666, 09KE000599, 10JE002167, 08AE000815, 11HE001077, 07CE006316, 11GE002140, 09AE004406, 10HE003939, 12LE001964, 08AE001460, 12FE002533, 07GE003779, 10BE004560, 12EE003798, 12AE004446, 11CE000376, 08CE004461, 09BE000696, 07GE003019, 10GE000065, 12GE000910, 12AE004445, 11BE001902, 08EE005132, 10JE004723, 08FE003037, 10GE001445, 08LE001637, 09JE004448, 07HE007056, 08GE005257, 12KE001796, 08IE003962, 11EE004258, 12HE000440, 08IE001873, 12CE001278, 10HE005310, 07CE006037, 08LE002086, 12AE003252, 08GE003571, 08JE001857, 08CE003689, 10IE002938, 08AE000097, 08LE004699, 12JE000793, 10IE004236, 09DE003470, 07EE005179, 11FE002072, 08KE002570, 09AE004162, 08FE000890, 12KE003044, 09FE002353, 08IE002705, 11IE001721, 09KE002898, 09DE000041, 10EE003753, 11LE001612, 09HE004420, 09BE001671, 12CE001718, 10JE000288, 09DE001693, 08JE004678, 09HE002105, 08CE002545, 10JE004948, 12GE002274, 10LE000831, 09EE001142, 08EE000469, 09HE003295, 08LE000475, 11CE003271, 09JE004169, 11CE004931, 09EE002097, 14BE000256, 10IE003191, 09KE000588, 11IE001325, 10DE004960, 11HE002998, 10GE005204, 14DE000058, 11LE003402, 09LE002451, 11KE001962, 11AE000831, 11CE000796, 08KE001107, 08KE000350, 07IE000965, 10KE002175, 12FE000726, 12GE000013, 07HE003346, 09FE000722, 09EE003796, 10LE000810, 11FE000326, 12HE000045, 08AE001714, 12CE001956, 11IE000042, 07GE000071, 13IE000297, 12KE002694, 12HE004254, 07GE005449, 11CE002264, 12BE001170, 11HE002992, 07AE000992, 13JE000511, 12KE001097, 08HE001971, 12JE003535, 13BE000263, 12BE000038, 09IE003663, 09CE005217, 14AE000181, 08JE001042, 06JE005407, 07JE004503, 09CE005225, 08JE003891, 09FE003732, 14EE000615, 10GE003611, 07GE000004, 06GE005314, 09GE002842, 12CE002400, 09HE004168, 08GE003065, 07DE004005, 07FE002656, 07BE001777, 13LE000542, 13GE000040, 10HE001202, 07JE002081, 09JE003505, 07GE001089, 07DE001600, 14AE000178, 07GE007036, 12EE001915, 12JE002773, 10IE002315, 08DE000304, 07GE004938, 11EE002579, 09BE003316, 12EE003051, 08AE003336, 11BE001161, 07IE001342, 07JE001641, 08LE000930, 12JE001739, 09DE003201, 08HE000291, 11BE002428, 10JE000745, 07JE001821, 10HE004334, 08GE000285, 12JE000983, 08LE000675, 11EE003369, 09IE000822, 09LE000315, 08HE002245, 09DE001699, 09IE000041, 10EE002449, 11JE002188, 08IE003724, 10AE002586, 10AE004224, 09IE000827, 09IE000036, 10HE000374, 12HE004445, 08IE003490, 10AE003278, 12BE001685, 09KE000075, 10BE001514, 10IE003428, 10JE000750, 09FE003044, 10CE001474, 13GE000856, 09FE002625, 10CE002992, 12HE002157, 09DE002253, 10CE001007, 10EE002375, 10LE003140, 13GE000136, 12EE002398, 12KE000087, 09JE001069, 10IE002068, 10EE002387, 11GE002330, 08HE000570, 10GE001002, 12LE002166, 10HE002686, 12FE001634, 10EE002386, 12CE006029, 10CE003697, 11FE001810, 09CE002077, 11IE000274, 07GE006407, 10EE004217, 10CE000062, 12JE002156, 13GE000202, 10BE002743, 12DE000209, 10HE001426, 10EE004218, 10LE003464, 14CE000138, 10FE003506, 10GE005061, 12GE002098, 10BE001505, 10FE000648, 11LE001678, 08FE000463, 10FE005562, 11EE003823, 08FE000072, 09HE004195, 10FE000649, 12FE001011, 12AE004935, 10GE004132, 11FE002080, 10AE003719, 08FE001363, 10FE000650, 12IE002787, 10EE003571, 11BE000060, 11FE002497, 08IE005162, 09GE004560, 10FE001909, 12IE003245, 14CE000495, 11EE004011, 08GE004775, 09BE001634, 10DE003641, 10JE000737, 07IE003629, 10CE001960, 09GE004935, 12GE001696, 09KE001990, 10EE003746, 10JE001784, 07KE001529, 11CE000298, 09KE000557, 07KE004154, 10HE002404, 10IE004512, 10KE004141, 08AE003577, 06LE007409, 10KE001915, 09DE000050, 09DE004576, 11DE003478, 10KE004315, 08HE000060, 09CE003690, 10KE003682, 09BE002555, 09HE002382, 13FE000616, 11AE002805, 08IE004246, 08GE003087, 11EE002327, 09DE005080, 09JE001823, 08BE000280, 11CE001977, 08KE003385, 09EE004657, 11IE002387, 08CE000052, 10JE004716, 09DE001155, 11DE003674, 09AE005327, 09GE000761, 12BE002811, 08HE004349, 10JE004987, 10CE001724, 11JE000043, 09AE004382, 08AE000261, 11CE002505, 09IE002099, 10LE005416, 11HE003390, 12CE000919, 09EE000048, 08KE001607, 11EE004475, 11AE001080, 11AE003858, 09AE004409, 13IE000421, 12LE002731, 09LE002923, 11LE002064, 07IE002722, 11IE003255, 10EE004881, 13IE000612, 07HE001408, 10KE000644, 12KE000090, 07FE007288, 07JE000042, 11HE002276, 07CE005297, 08HE005009, 10KE000643, 14CE000480, 07JE003813, 09GE001681, 08IE001607, 08DE002291, 08IE004660, 10LE003663, 10LE003105, 06KE006044, 13DE000752, 11JE000233, 10FE003207, 09FE005586, 07JE005624, 06JE006242, 08EE000483, 07KE003039, 11DE004352, 10IE002309, 09GE004023, 09JE002938, 08AE003065, 09DE004178, 07GE000072, 07EE005412, 10KE003881, 09HE001043, 09LE002457, 08BE003886, 09DE003194, 07IE000136, 07HE005471, 11AE002638, 09JE002975, 10GE000806, 10GE001870, 12AE001878, 08CE003313, 09DE001652, 11JE001349, 10HE000072, 08CE000588, 10JE002918, 07EE007022, 08DE000045, 10AE001483, 11JE003171, 10HE004004, 09JE004933, 11BE000476, 10DE002108, 08HE002916, 10HE003260, 11LE002529, 10KE004942, 10LE000559, 11CE001778, 11BE003563, 09KE001393, 10IE004796, 13GE000583, 11AE001740, 10LE002533, 12EE004457, 11EE003372, 10DE001843, 10KE002739, 07EE001744, 11DE001327, 11IE002384, 10FE004795, 11LE002733, 10EE001646, 11EE002283, 07CE005265, 11IE001400, 11IE003250, 11GE001290, 12BE002817, 12BE001822, 11HE001667, 07GE006548, 11JE002736, 13AE000983, 11LE001607, 12JE000046, 12BE002307, 12AE003656, 07HE001783, 12FE000604, 08FE005388, 12KE003718, 10FE003777, 12CE002663, 12CE000951, 07IE003978, 11AE000874, 10DE004537, 11JE004482, 10JE001228, 12EE002757, 12FE002286, 07LE002537, 11AE000875, 11HE000517, 12JE000323, 10JE003872, 12KE000877, 14AE000538, 08EE003356, 11FE002753, 09KE001147, 12KE004136, 11HE002513, 07HE005503, 08CE000036, 08FE002202, 09CE002776, 10BE000307, 11GE001896, 11KE000425, 08EE002585, 07LE004212, 08FE003316, 11DE004536, 08IE004650, 12CE000754, 12IE002279, 08HE004771, 08FE003884, 08FE005379, 08HE002622, 08JE003110, 10JE003912, 10BE000798.
Other Recalls from Invacare Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1251-2024 | Class II | Invacare Homecare Series Bed and Invacare G-Ser... | Jan 22, 2024 |
| Z-2445-2023 | Class II | DOLOMITE GLOSS ROLLATOR - intended to support d... | Jun 15, 2023 |
| Z-1369-2022 | Class III | Invacare Platinum 5NXG Oxygen Concentrator, Mod... | Jun 10, 2022 |
| Z-1130-2022 | Class II | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG... | Mar 30, 2022 |
| Z-0445-2022 | Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchai... | Nov 12, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.