BEUDAMED
    FDA Enforcement Class II Ongoing

    Barco MDSC-8527 NXF, Part Number K9352421

    Recall: Z-0979-2024 · Reported February 14, 2024

    Enforcement

    Recall Number
    Z-0979-2024
    Event ID
    93712
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Barco N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 14, 2024
    Initiation Date
    December 20, 2023
    Classification Date
    February 2, 2024
    Address
    President Kennedypark 35, Kortrijk, N/A, Belgium

    Description

    Barco MDSC-8527 NXF, Part Number K9352421

    Reason

    Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.

    Code Info

    UDI/DI 05415334043312

    Distribution

    US Nationwide distribution in the state of New Jersey.

    Quantity

    2 units