BEUDAMED
    FDA Recall 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 · Initiated October 24, 2014

    Recall

    Recall Number
    Z-0804-2015
    Event Number
    69864
    Firm
    AGFA Healthcare Corp.
    FEI Number
    3001236302
    Product Code
    IWZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 24, 2014
    Posted
    December 16, 2014
    Terminated
    March 16, 2015
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    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.

    Action

    Dealers were contacted by Agfa HealthCare via phone and/or email on 10/24/2014 and the week of 11/10/14 to inform them of the quality issue and to quarantine identified product shipped to their facility or end users. On 11/17/2014, an "URGENT SAFETY NOTICE" letter was sent to the US dealers. The letter described the safety alert and the request to quarantine affected product. Acknowledgment via FAX-Back or email that the information was received and understood was requested from the dealers. A customer Urgent Field Safety Notice was also provided to those dealers who had shipped affected product to end users so they could sent it to the end use customers.

    Distribution

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

    Quantity

    142 units