BEUDAMED
    FDA Enforcement Class III Terminated

    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

    Recall: Z-2176-2014 · Reported August 20, 2014

    Enforcement

    Recall Number
    Z-2176-2014
    Event ID
    68798
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    August 20, 2014
    Initiation Date
    May 13, 2014
    Classification Date
    August 9, 2014
    Termination Date
    August 13, 2014
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

    Reason

    Unit was mislabeled with a factory label showing 32 KW output power.

    Code Info

    Serial Number A5410000042

    Distribution

    US in the state of WV

    Quantity

    1