BEUDAMED
    FDA Enforcement Class II Terminated

    AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.

    Recall: Z-1487-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1487-2013
    Event ID
    65223
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    May 15, 2013
    Classification Date
    June 6, 2013
    Termination Date
    December 31, 2014
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.

    Reason

    Customers could potentially experience intermittent, unintended and illogical movement when using the product.

    Code Info

    Material numbers in US - 5Q82F, 5R75Q, 5Q8ZB, 5R77U & 58Q1D - Material numbers in Canada - 5R78W & 5R77U

    Distribution

    Worldwide Distribution - US Nationwide including the states of AL, FL, IL, IN, IA, KY, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OR, SC, TN, VA, WV, WY and the country of Canada

    Quantity

    104