BEUDAMED
    FDA Enforcement Class II Terminated

    Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

    Recall: Z-1172-2021 · Reported March 10, 2021

    Enforcement

    Recall Number
    Z-1172-2021
    Event ID
    87288
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Barco N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 10, 2021
    Initiation Date
    January 22, 2021
    Classification Date
    March 4, 2021
    Termination Date
    November 18, 2022
    Address
    President Kennedypark 35, Kortrijk, N/A, Belgium

    Description

    Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY

    Reason

    A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.

    Code Info

    Model Number: MDNC-3421, Serial number 2590263533, UDI/DI 05415334028388.

    Distribution

    WI.

    Quantity

    1 unit