BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMOBIL SMART DRIVE MX2+ SPEEDCONTROL DIAL

    MDR report key: 24789990 · Received April 6, 2026

    Report

    Report Number
    MW5186354
    Event Type
    Other
    Date Received
    April 6, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    MAX MOBILITY, LLC.
    Product Code
    ITI
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED IN DUE TO A RECALL LETTER SHE RECEIVED. PATIENT IS NOT EXPERIENCING ANY ADVERSE AFFECTS FROM THE DEVICE. RECALL # IS Z-1116-2025. PATIENT STATES THAT THE LETTER SPECIFIES: SPEED CONTROL DIAL IS HAVING UNCONTROLLABLE BEHAVIOR. THE CONTROL MOTOR DIAL THAT CONTROLS THE SPEED OF THE WHEELCHAIR IS EXPERIENCING INVOLUNTARY MOVEMENTS WHEN NOT DIRECTED OR SHUTOFF. THE WHEELCHAIR IS NOT STOPPING WHEN IT IS SUPPOSED TO STOP. RECALL INFO GOES AS FOLLOWS: HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFRES/RES.CFM?ID=215322.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600608 PERMOBIL SMART DRIVE MX2+ SPEEDCONTROL DIAL WHEELCHAIR, POWERED ITI MAX MOBILITY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female