Recall Z-1139-2015
Invacare Corporation · initiated January 15, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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, 08FE003622, 12DE000616, 07JE000966, 08LE005085, 11EE003780, 12GE003127, 12EE002756, 08FE003317, 13AE001235…
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-1139-2015
- Initiated
- January 15, 2015
- Posted by FDA
- February 20, 2015
- Terminated
- September 23, 2015
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 525
- 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
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1137-2015 Class II | TDX 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-1138-2015 Class II | FDX 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 |