BEUDAMED
    FDA Enforcement Class II Ongoing

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    Recall: Z-1854-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1854-2022
    Event ID
    90807
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BARCO NV
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 5, 2022
    Initiation Date
    July 27, 2022
    Classification Date
    September 29, 2022
    Address
    Beneluxpark 8500, N/A, Kortrijk, N/A, N/A, Bulgaria

    Description

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    Reason

    installation issues

    Code Info

    a) K9303078A, UDI 05415334000056, all serial numbers; b) K9303097A, UDI 05415334001657, all serial numbers

    Distribution

    US Nationwide distribution in the states of FL, IL, NJ.

    Quantity

    169 devices