TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 24 inch width configu

FDA device recall Z-1137-2015 · posted 2015-02-20 · Terminated

Recall details

Recalling firm

Invacare Corporation

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.

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.

Root cause

Device Design

Status

Terminated

Product code

ITI

Quantity affected

1942

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

Date initiated

2015-01-15

Date posted

2015-02-20

Date terminated

2015-09-23

Location

Elyria, OH

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