BEUDAMED
    FDA Recall Open, Classified

    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    Recall: Z-1130-2022 · Initiated March 30, 2022

    Recall

    Recall Number
    Z-1130-2022
    Event Number
    90084
    Firm
    Invacare Corporation
    FEI Number
    1525712
    Product Code
    ITI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 30, 2022
    Address
    1200 Taylor St, Elyria, OH, 44035-6248

    Description

    Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V

    Reason

    The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.

    Action

    A preliminary notification was sent to providers on March 30, 2022, introducing the product issue and providing instructions regarding how to handle impacted units before field correction kits are available. A notification letter dated April 13, 2022, was sent to impacted consignees via traceable mail. This mailing includes a Provider Letter which will introduces the field correction requirements and provides instructions for acknowledging awareness and understanding of the requested field correction activities. Providers should inform affected customers to inform them that their wheelchair is subject to recall and requires repair. The letter provides user precautions that must be taken until the wheelchair is repaired. If you have any questions concerning this recall, please call Invacare s field correction support line at (877) 413-6008

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, AR, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA, and WI. The country of Canada.

    Quantity

    133 devices