BEUDAMED
    FDA Enforcement Class III Terminated

    Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

    Recall: Z-0804-2015 · Reported December 24, 2014

    Enforcement

    Recall Number
    Z-0804-2015
    Event ID
    69864
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 24, 2014
    Initiation Date
    October 24, 2014
    Classification Date
    December 15, 2014
    Termination Date
    March 16, 2015
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

    Reason

    Some material of the coating Type CXCPMV3 has potential artifacts showing a small bright thin line when the film is processed.

    Code Info

    Lot 79440009

    Distribution

    US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA

    Quantity

    142 units