BEUDAMED
    FDA Enforcement Class II 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 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1070-2013
    Event ID
    64656
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    March 15, 2013
    Classification Date
    April 8, 2013
    Termination Date
    January 9, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    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.

    Code Info

    Model # L9M21000. Software versions: IMPAX CV 7.8, 7.8 SU1, 7.8 SU2 and 7.8 SU3, IMPAX CV 7.8 SU2.5 with IMPAX CV Outbound Report Stylesheet 7.8_HL

    Distribution

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

    Quantity

    26