BEUDAMED
    FDA Enforcement Class II Terminated

    Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.

    Recall: Z-2588-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2588-2021
    Event ID
    88469
    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
    October 6, 2021
    Initiation Date
    June 10, 2021
    Classification Date
    September 29, 2021
    Termination Date
    February 3, 2026
    Address
    Ul. Ks. Piotra Wawrzyniaka 2, N/A, Komorniki, N/A, N/A, Poland

    Description

    Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and subsequently retrofitted on the beds.

    Reason

    The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.

    Code Info

    Manufacturing dates 5/25/2018-2/15/2021 (printed on both the bed and IndiGo module if the module was assembled on the bed at the time of manufacture, or printed on the module if it was later installed on the bed.

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.

    Quantity

    367 units