Recall Z-1138-2015

Invacare Corporation · initiated January 15, 2015

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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.

Codes / lots: 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…

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: Device Design

Action taken

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.

Details

Recall number
Z-1138-2015
Initiated
January 15, 2015
Posted by FDA
February 20, 2015
Terminated
September 23, 2015
Product code
ITI – Wheelchair, Powered
Quantity
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.
Recalling firm
Invacare Corporation, Elyria, OH

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1137-2015 Class IITDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power…If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users… 01/15/2015Terminated
Z-1139-2015 Class IIStorm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power…If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users… 01/15/2015Terminated