FDA Medical Device Recalls (openFDA)
Invacare Corporation: TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: Invacare Corporation, Elyria, OH 44035 The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability.
- Recall number
- Z-1201-2012
- Recalling firm
- Invacare Corporation
- Product
- TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By: Invacare Corporation, Elyria, OH 44035 The Invacare TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or non-folding type power wheelchair, with mid wheel drive capability.
- Status
- Terminated
- Initiated
- 2012-02-10
- Posted
- 2012-03-12
- Terminated
- 2014-08-25
- Reason
- Invacare Corporation decided to recall the product because use of this actuator could result in reduced cross sectional current carrying area due to wear/chafing of the wires.
- Root cause
- Nonconforming Material/Component
- Action
- The firm, Invacare, sent an "URGENT: RECALL INFORMATION" letter dated February 10, 2012 to their consignees/customers. The letter described the product, problem and actions to be taken. Invacare has developed retrofit kits intended to address this issue. The consignees were instructed to contact the customers that have potentially affected product and perform the necessary updates. The consignees were also instructed to complete and return the Provider Response Form to order the retrofit kit. If you have any questions, please contact Customer Service at 1-800-333-6900.
- Quantity
- 102 wheelechairs
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AZ, CA, CT, FL, GA, IA, IL, IN, KY, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, RI, SD, TX, VA, WA, and WI; and countries of: Australia, Canada and New Zeland.
- Lot, serial or model codes
- Model# TDXDP-CG, Serial# 11HE001056; Model# TDXP-CG, Serial# 11GE004364, 11HE000039; Model# TDXSP-CG, Serial# 11GE001580, 11GE001593, 11GE001874, 11GE001886, 11GE001919, 11GE001919, 11GE001920, 11GE002363, 11GE002455, 11GE002456, 11GE002464, 11GE002622, 11GE002625, 11GE002635, 11GE002839, 11GE002850, 11GE003048, 11GE003075, 11GE003249, 11GE003258, 11GE003500, 11GE003503, 11GE003687, 11GE003690, 11GE003931, 11GE003934, 11GE004230, 11GE004354, 11GE004355, 11GE004356, 11GE004359, 11GE004361, 11GE004490, 11GE004638, 11GE004642, 11HE000047, 11HE000333, 11HE000335, 11HE000343, 11HE000344, 11HE000508, 11HE000748, 11HE000749, 11HE000752, 11HE000755, 11HE000848, 11HE001057, 11HE001243, 11HE001244, 11HE001246, 11HE001311, 11HE001515, 11HE001645, 11HE001647, 11HE001653, 11HE001659, 11HE001838, 11HE001843, 11HE00756; Model# TDXSP-CG-GT, Serial# 11GE001891, 11GE002134, 11GE002849, 11GE003064, 11GE003504; Model# TDXSP-CT-GT, Serial# 11GE002849; Model# TDXSP-MCG, Serial# 11GE000322, 11GE001567, 11GE001894, 11GE002136, 11GE002137, 11GE002372, 11GE002376, 11GE002377, 11GE002378, 11GE002382, 11GE002383, 11GE002385, 11GE002657, 11GE002852, 11GE003065, 11GE003067, 11GE003070, 11GE003073, 11GE003252, 11GE003261, 11GE003263, 11GE003266, 11GE003711, 11GE003712, 11GE003938, 11GE004134, 11GE004135, 11GE004368, 11HE000055, 11HE000102, 11HE000348, 11HE000511, 11HE000761, 11HE001250, 11HE001450, 11HE002071 & 11HE002523.
- 510(k) numbers
- ["K023589"]
- PMA numbers
- not on file
- Product code
- ITI
- Firm FEI
- 3002889431
- Firm city
- Elyria
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28