BEUDAMED
    FDA Enforcement Class II Terminated

    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.

    Recall: Z-2821-2020 · Reported August 26, 2020

    Enforcement

    Recall Number
    Z-2821-2020
    Event ID
    86065
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ARJOHUNTLEIGH POLSKA Sp. z.o.o.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2020
    Initiation Date
    July 21, 2020
    Classification Date
    August 18, 2020
    Termination Date
    February 17, 2021
    Address
    Ui. Ks. Piotra Wawrzyniaka 2, N/A, Komorniki, N/A, N/A, Poland

    Description

    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.

    Reason

    Modular Junction Box (MJB) cables can melt and affect the bed functionality.

    Code Info

    Serial number range: P0597830 to P0610470 Model numbers: FXX21A4A4AKFBB, FXX21A4D3AMFBA, FXX21C4B1AAABB, FXX21C4B4ABQBA, FXX21A4C4ACGBB, FXX21A4A1ABUBA, FXX21A6C2ABPBB, FXX21C4B1AAABA, FX811B3B4AMABB, FXX21C4D4AKBBB, FX611A2B2ALVBB

    Distribution

    Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.

    Quantity

    145 units