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U.S. Department of Health and Human Services

Class 2 Device Recall Invacare FDX

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  Class 2 Device Recall Invacare FDX see related information
Date Initiated by Firm January 15, 2015
Date Posted February 20, 2015
Recall Status1 Terminated 3 on September 23, 2015
Recall Number Z-1138-2015
Recall Event ID 69378
510(K)Number K991168  
Product Classification Wheelchair, powered - Product Code ITI
Product FDX 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.
Code Information Model # FDX-CG FDX-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, 08FE003622, 12DE000616, 07JE000966, 08LE005085, 11EE003780, 12GE003127, 12EE002756, 08FE003317, 13AE001235, 08DE000039, 10AE002104, 08BE002786, 12IE002542, 09CE002495, 08BE004214, 13LE000634, 08HE000567, 07JE004502, 09BE002772, 12JE001455, 13JE000299, 07BR003307, 14FE000447, 08IE002133, 08JE000302, 09BE002767, 12JE001637, 10IE001126, 12BE003254, 07IE004514, 08JE001851, 08EE002568, 09BE003009, 12KE001301, 11BE003967, 07BE003307, 07LE003702, 08JE002532, 12LE000919, 09JE003794, 09DE001338, 08CE003643, 08GE001008, 08BE003889, 08KE001596, 10HE005506, 10FE004526, 11AE003675, 08FE004118, 14DE000609, 11EE002528, 09BE003741, 08LE001401, 11KE001494, 12CE002397, 09FE002368, 08FE005384, 11HE001416, 10BE004558, 10HE000061, 08FE000073, 13EE000415, 09HE001200, 08CE003640, 13AE000611, 10KE000049, 10FE004487, 07LE003939, 09GE001218, 09HE005212, 08EE002092, 09HE000061, 13DE000700, 10LE003114, 10LE002780, 09BE003491, 09IE004153, 08EE002090, 10CE000059, 08KE000352, 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Recalling Firm/
Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information Contact Swasita Saigal
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action The firm initiated the recall on 01/16/15 by sending a notification letter to customers through the mail. Communication was sent to providers to contact consignees via mail return receipt to inform them of the recall. Recall notification included a Provider letter, Consumer letter, Provider Response card, Unit Disposition form and tracking sheet and the Wiring guide. The notification instructed the provider to visually inspect all potentially impacted chairs. Not all potentially impacted chairs are expected to have improperly routed and secured wires.
Quantity in Commerce 60
Distribution 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.
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.