BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-1117-2025 · Reported February 19, 2025

    Enforcement

    Recall Number
    Z-1117-2025
    Event ID
    96086
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Max Mobility LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2025
    Initiation Date
    December 20, 2024
    Classification Date
    February 11, 2025
    Address
    300 Duke Dr, Lebanon, TN, 37090-8115, United States

    Description

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

    Reason

    Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.

    Code Info

    All serial numbers manufactured between August 17,2023 through November 21, 2024

    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: Sweden, Canada, Australia, Japan, New Zealand, Colombia, Argentina, Hong Kong, Canada, Mexico, Bermuda, South Korea, Chile

    Quantity

    unknown