BEUDAMED
    FDA Recall Terminated

    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: Z-1201-2012 · Initiated February 10, 2012

    Recall

    Recall Number
    Z-1201-2012
    Event Number
    61160
    Firm
    Invacare Corporation
    FEI Number
    3002889431
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 10, 2012
    Posted
    March 12, 2012
    Terminated
    August 25, 2014
    Address
    1 Invacare Way, Elyria, OH, 44035-4190

    Description

    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.

    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.

    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.

    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.

    Quantity

    102 wheelechairs