Recall Z-1139-2015— Invacare Corporation

Name: FDA recall Z-1139-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-15

Class II · Terminated

Class II FDA medical device recall by Invacare Corporation, initiated 2015-01-15, terminated 2015-09-23. It names one FDA 510(k) clearance: K940051. 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.. 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..

Recalling firm: Invacare Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-01-15
Terminated: 2015-09-23
Firm location: Elyria, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K940051 — ACTION STORM POWER WHEELCHAIRInvacare Corp.·cleared 1994-03-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.