Recall Z-1905-2012— Invacare Corporation

Name: FDA recall Z-1905-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-06

Class II · Terminated

Class II FDA medical device recall by Invacare Corporation, initiated 2012-04-06, terminated 2014-05-20. It names 2 FDA 510(k) clearances: K023589, K991168. Product: TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.. Reason: Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse..

Recalling firm: Invacare Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-04-06
Terminated: 2014-05-20
Firm location: Elyria, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K023589 — STORM TDX POWER WHEELCHAIRInvacare Corp.·cleared 2002-11-19
K991168 — ARROW FWD POWER WHEELCHAIRInvacare Corp.·cleared 1999-06-25

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

TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. Intended to provide mobility to a person restricted to a sitting position.

Reason for recall

Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury. The post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.

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