BEUDAMED
    FDA Recall Terminated

    Pronto Series Power Wheelchair, model M51.

    Recall: Z-0902-05 · Initiated May 2, 2005

    Recall

    Recall Number
    Z-0902-05
    Event Number
    32009
    Firm
    Invacare Corporation
    FEI Number
    3002889431
    Product Code
    ITI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 2, 2005
    Posted
    June 17, 2005
    Terminated
    January 4, 2008
    Address
    1 Invacare Way PO Box 4028, Elyria, OH, 44036-2028

    Description

    Pronto Series Power Wheelchair, model M51.

    Reason

    If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.

    Action

    The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.

    Distribution

    The product was sent to consignees located in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. There was one foreign consignee in France: Poirer, Zac Papillon, 3720 Parcay Meslay, Corps, France

    Quantity

    1418 devices.