BEUDAMED
    FDA Enforcement Class II Ongoing

    Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

    Recall: Z-0713-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0713-2024
    Event ID
    93556
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    mo-Vis BVBA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    November 28, 2023
    Classification Date
    January 11, 2024
    Address
    Biebuyckstraat 15D, Nevele, N/A, Belgium

    Description

    Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair

    Reason

    In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers.

    Code Info

    UDI-DI: 05407008320119; Lot Numbers: 3304-3317 3322-3329 3440-3452 3569-3618 3830-3844 4020-4054 4170-4176 4250-4255 4321-4330

    Distribution

    US States: TN, TX.

    Quantity

    129 units