BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated August 12, 2025

    Recall

    Recall Number
    Z-2538-2025
    Event Number
    97356
    Firm
    Max Mobility LLC
    FEI Number
    3008370857
    Product Code
    ITI
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    August 12, 2025
    Posted
    September 12, 2025
    Address
    300 Duke Dr, Lebanon, TN, 37090-8115

    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.

    Action

    On August 12, 2025, Permobil issued a "Urgent Medical Device Recall Expansion/Update" via email. This expansion supersedes the Class I recall ((Z-1116-2025, Z-1117-2025), initiated on December 20, 2024. Permobil asked consignees to take the following actions: 1. Immediately discontinue use of the SpeedControl dial to reduce the likelihood of a potentially hazardous or harmful situation. 1. Since all SpeedControl Dials are impacted by this recall, remove SpeedControl Dials from your sellable / distribution inventory 2. Use an alternate method to control the SmartDrive MX2+ Power Assist Device. Alternate controls include: " A wired SwitchControl, which can be ordered with a mono jack port to connect with an optional Buddy Button " Wirelessly through the SmartDrive MX2+ App utilizing a Apple iWatch or Samsung Galaxy watch. 3.Immediately contact any customers you have distributed the device to and provide a copy of this notice. It is also recommended that this notice be posted in your clinic/facility 4. You are required to acknowledge that you received this Urgent Medical Device Recall letter. Please complete within 10 days of receipt of the letter. Please use the QR code below to access the field action portal to record your acknowledgement

    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