BEUDAMED
    FDA Enforcement Class I Ongoing

    IDM-MULTI-R. Electrical wheelchair component.

    Recall: Z-2457-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2457-2025
    Event ID
    97354
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    mo-Vis BVBA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 10, 2025
    Initiation Date
    July 10, 2025
    Classification Date
    September 2, 2025
    Address
    Biebuyckstraat 15D, N/A, Nevele, N/A, N/A, Belgium

    Description

    IDM-MULTI-R. Electrical wheelchair component.

    Reason

    Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.

    Code Info

    Model No. PRSPS0016; UDI-DI: 05407008320850; Serial No. 1000 to 1690.

    Distribution

    US Nationwide distribution in the state of TX.

    Quantity

    15 units