BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    Recall: Z-0923-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0923-2026
    Event ID
    98101
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    N/A
    Report Date
    December 31, 2025
    Initiation Date
    November 18, 2025
    Classification Date
    December 22, 2025
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    Reason

    It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

    Code Info

    N/A

    Distribution

    U.S. Nationwide distribution.

    Quantity

    35