BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0923-2026 · Initiated November 18, 2025

    Recall

    Recall Number
    Z-0923-2026
    Event Number
    98101
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    IZF
    Status
    Open, Classified
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    November 18, 2025
    Posted
    December 22, 2025
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    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.

    Action

    AGFA NV notified Customers via a letter titled "IMPORTANT PRODUCT INFORMATION LETTER / DR 800", included Product Name, Symptom, Cause, Actions to be taken customer and manufacturers respectively: "Always enable ABS for pulsed fluoro exams. Actions being taken by the manufacturer: Agfa/local business partner will contact you to install a new generator software."

    Distribution

    U.S. Nationwide distribution.

    Quantity

    35