BEUDAMED
    FDA Enforcement Class I Ongoing

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    Recall: Z-2538-2025 · Reported September 24, 2025

    Enforcement

    Recall Number
    Z-2538-2025
    Event ID
    97356
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Max Mobility LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 24, 2025
    Initiation Date
    August 12, 2025
    Classification Date
    September 12, 2025
    Address
    300 Duke Dr, N/A, Lebanon, TN, 37090-8115, United States

    Description

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    Reason

    Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.

    Code Info

    All Serial Numbers distributed between the dates of April 25, 2022 - July 8, 2025

    Distribution

    US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY OUS: CAN, NZL, KOR, BMU, GBR, JPN, TWN, AUS, BRA, COL, MEX, ABW, SWE, CHL, ARG, HKG

    Quantity

    25,389 units