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.
FDA Recall Z-1201-2012 · Posted 2012-03-12
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Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeITI
Date Initiated2012-02-10
Date Terminated2014-08-25
Product Quantity102 wheelechairs
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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