BEUDAMED
    FDA Recall Terminated

    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

    Recall: Z-1070-2013 · Initiated March 15, 2013

    Recall

    Recall Number
    Z-1070-2013
    Event Number
    64656
    Firm
    AGFA Corp.
    FEI Number
    3001236302
    Product Code
    LLZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 15, 2013
    Posted
    April 8, 2013
    Terminated
    January 9, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632

    Description

    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.

    Reason

    Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.

    Action

    AGFA sent an "URGENT FIELD SAFETY NOTICE" letter dated March 15, 2013 to the consignees who use the IMPAX CV Reporting tool described for this issue. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 877-777-2432, referencing HQ_10020006 for questions regarding this notice.

    Distribution

    Nationwide Distribution including the states of AK, GA, IL, KY, MA, NY, NC, RI, SC, TX, and VA.

    Quantity

    26