BEUDAMED
    FDA Enforcement Class II Terminated

    MK5 NX Controller--Wheelchair controller

    Recall: Z-2091-2014 · Reported July 30, 2014

    Enforcement

    Recall Number
    Z-2091-2014
    Event ID
    68622
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2014
    Initiation Date
    June 24, 2014
    Classification Date
    July 22, 2014
    Termination Date
    October 15, 2014
    Address
    1200 Taylor St, Elyria, OH, 44035-6248, United States

    Description

    MK5 NX Controller--Wheelchair controller

    Reason

    M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control.

    Code Info

    P/N 1143839

    Distribution

    Nationwide Distriution: CA, SC, IL, UT, TN, KS, HI, NJ, LA, TX,FL, IN, AL, AZ, MN, WI, MN, MI, AR,MA, GA, MS, NJ, NM, OK, ME, PA, NY, NC, OK, MO, WA, IA, OR,KY, MD, NE, ID, VA, WA, ND, MT, OH, NH, CT. Also shipped to Canada

    Quantity

    819