BEUDAMED
    FDA Enforcement Class II Ongoing

    SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198

    Recall: Z-0329-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0329-2025
    Event ID
    95490
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    WISSNER-BOSSERHOFF GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 20, 2024
    Initiation Date
    July 11, 2022
    Classification Date
    November 8, 2024
    Address
    Hauptstr. 4-6, N/A, Wickede (Ruhr), N/A, N/A, Germany

    Description

    SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198

    Reason

    When the handset is disconnected from the power mains, and mains operation is restored, the handset is reset to the preset Resident mode. In this mode, the backrest, legrest, and height adjustment can be moved.

    Code Info

    UDI/DI 4050621100401, 19-0990 UDI/DI 4050621100012, 19-1062 UDI/DI 4050621100432, 19-1152 UDI/DI 4050621100449, 19-1119 UDI/DI 4050621100470, 19-1155 UDI/DI 4050621100487, 19-1156

    Distribution

    US Nationwide distribution in the states of NC.

    Quantity

    77 units