BEUDAMED
    FDA Recall Open, Classified

    iBOT PMD with software version 01.05.24. Personal Mobility Device.

    Recall: Z-1965-2025 · Initiated April 24, 2025

    Recall

    Recall Number
    Z-1965-2025
    Event Number
    96834
    Firm
    Mobius Mobility LLC
    FEI Number
    3014522447
    Product Code
    IMK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 24, 2025
    Posted
    June 12, 2025
    Address
    540 N Commercial St, Ste 310, Manchester, NH, 03101-1146

    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.

    Action

    Consignees were initially contacted via telephone on 4/24/25 to notify them of this software issue. An URGENT MEDICAL DEVICE CORRECTION NOTICE dated 5/5/25 was emailed to consignees to notify them of the recall and instructing them that the firm is developing a software correction. Once Mobius Mobility has obtained a correction they will reach out to consignees to schedule a time to update affected devices. Consignees with any questions can email service @mobiusmobility.com or call 833-346-4268x2.

    Distribution

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

    Quantity

    442 units