BEUDAMED
    FDA Enforcement Class II Ongoing

    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules

    Recall: Z-0611-2024 · Reported January 3, 2024

    Enforcement

    Recall Number
    Z-0611-2024
    Event ID
    93463
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ARJOHUNTLEIGH POLSKA Sp. z.o.o.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 3, 2024
    Initiation Date
    August 29, 2023
    Classification Date
    December 22, 2023
    Address
    Ul. Ks. Piotra Wawrzyniaka 2, Komorniki, N/A, Poland

    Description

    Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules

    Reason

    Unintended movement of bed wheels

    Code Info

    UDI/DI 0505609734548, serial numbers: P0504690, P0504691, P0510813, P0512547, P0512548, P0515453, P0515454, P0515455, P0515456, P0515457, P0516242, P0517649, P0517650, P0517651, P0517652, P0517653, P0517654, P0517655, P0517656, P0517657, P0517658, P0519068, P0525670, P0525671, P0525672, P0525673, P0525674, P0525675, P0525676, P0525677, P0525678, P0525679, P0525680, P0525681, P0525682, P0525683, P0525684, P0525685, P0525686, P0526405, P0526406, P0526407, P0526408, P0526409, P0526410, P0526425, P0526426, P0526427, P0526428, P0526429, P0526430, P0526431, P0526432, P0527297, P0527298, P0527299, P0527300, P0527301, P0527302, P0529533, P0529534, P0529535, P0529536, P0494034, P0494035, P0494036, P0494037, P0494038, P0494039, P0494040, P0494041, P0494042, P0494043, P0494044, P0494045, P0494046, P0494047, P0494048, P0501255, P0501256, P0501257, P0501258, P0501259

    Distribution

    US: TN, CA, NY, IL, NV, PA, SD

    Quantity

    83 units