BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1905-2012 · Initiated April 6, 2012

    Recall

    Recall Number
    Z-1905-2012
    Event Number
    61555
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 6, 2012
    Posted
    June 29, 2012
    Terminated
    May 20, 2014
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    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

    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.

    Action

    Invacare sent an "URGENT: RECALL INFORMATION" letter dated June 7, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. THe letters instructs customers to examine their inventory for the affected product and quarantine any product found. AProvider Response Form was enclosed for customers to complete and return via fax to 888-345-0289. Contact the firm at 888-641-9738 for assistance with this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Puerto Rico and the countries of Australia, Germany, New Zealand.

    Quantity

    665 affected power wheel chairs and 15 post-fuse assembly service parts have been identified.