FDA Recall Terminated

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.

Recall: Z-1139-2015 · Initiated January 15, 2015

Recall

Recall Number
Z-1139-2015
Event Number
69378
Firm
Invacare Corporation
FEI Number
1525712
Product Code
ITI
Status
Terminated
Root Cause
Device Design
Initiated
January 15, 2015
Posted
February 20, 2015
Terminated
September 23, 2015
Address
1200 Taylor St, Elyria, OH, 44035-6248

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

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.

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.

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.

Quantity

525