BEUDAMED
    FDA Recall Terminated

    IMPAX CV Results Manager/Results Manager Administration Tool

    Recall: Z-2112-2010 · Initiated June 11, 2010

    Recall

    Recall Number
    Z-2112-2010
    Event Number
    56090
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 11, 2010
    Posted
    July 29, 2010
    Terminated
    July 2, 2013
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX CV Results Manager/Results Manager Administration Tool

    Reason

    Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators.

    Action

    A letter was sent to the consignee on 6/11/2010 indicating what steps would be taken by Agfa concerning the problem. The letter also included a feedback form which was to be returned to Agfa. The recall was expanded and a "URGENT SAFETY NOTICE" was sent to each additional consignee on January 25, 2012. The letter described the potential issue and mitigation. Acknowledgment, via FAX-Back or email, that the information was received and understood has been requested from the additional consignees.

    Distribution

    AK, AZ, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, MS, MT, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI and Canada

    Quantity

    358