RecallRadar

FDA Device recall Z-1138-2015

FDX Electric Wheelchair

On 2015-03-04 the FDA classified a Class II recall of FDX Electric Wheelchair by Invacare, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1138-2015
ClassificationClass II
Statusterminated
Initiated2015-01-15
Published2015-03-04
Last updated2026-09-13 11:53 UTC
CompanyInvacare
DistributionUS

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.

Reason

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.

Identifiers

code_info
Model # FDX-CG FDX-MCG. Serial numbers for all models 11KE003137, 11LE003215, 10LE000825, 10JE000783, 08GE001643,…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, 12GE

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1138-2015%22

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