BEUDAMED
    FDA Enforcement Class II Ongoing

    iBOT PMD with software version 01.05.24. Personal Mobility Device.

    Recall: Z-1965-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1965-2025
    Event ID
    96834
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mobius Mobility LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 18, 2025
    Initiation Date
    April 24, 2025
    Classification Date
    June 12, 2025
    Address
    540 N Commercial St Ste 310, Manchester, NH, 03101-1146, United States

    Description

    iBOT PMD with software version 01.05.24. Personal Mobility Device.

    Reason

    Software issue that could potentially lead to the device tipping over from Balance Mode.

    Code Info

    Software Version 01.05.24; UDI (01) 00857584008010 (21) 0001108, (01) 00857584008010 (21) 0001110, (01) 00857584008010 (21) 0001121, (01) 00857584008010 (21) 0001123, (01) 00857584008010 (21) 0001128, (01) 00857584008010 (21) 0001136, (01) 00857584008010 (21) 0001137, (01) 00857584008010 (21) 0001422, (01) 00857584008010 (21) 0001438, (01) 00857584008010 (21) 0001496, (01) 00857584008010 (21) 0001505, (01) 00857584008010 (21) 0001508, (01) 00857584008010 (21) 0001516, (01) 00857584008010 (21) 0001517, (01) 00857584008010 (21) 0001519; Serial No. 0001108, 0001422, 0001438, 0001496, 0001505, 0001508, 0001516, 0001517, 0001519, 0001110, 0001121, 0001123, 0001128, 0001136, 0001137.

    Distribution

    US Nationwide distribution in the states of CA, CO, FL, GA, IN, NC, NJ, OH, PR, RI, TN, TX & VA.

    Quantity

    442 units