BEUDAMED
    FDA Enforcement Class II Terminated

    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

    Recall: Z-1502-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1502-2020
    Event ID
    85028
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Agfa N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 25, 2020
    Initiation Date
    February 10, 2020
    Classification Date
    March 18, 2020
    Termination Date
    March 30, 2023
    Address
    Septestraat 27, Mortsel, N/A, Belgium

    Description

    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

    Reason

    Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

    Code Info

    Serial Numbers: 00949, 1161

    Distribution

    US Nationwide distribution in the states of FL, VA.

    Quantity

    2 units