BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.

    Recall: Z-2069-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2069-2012
    Event ID
    62534
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 1, 2012
    Initiation Date
    July 10, 2012
    Classification Date
    July 24, 2012
    Termination Date
    October 29, 2013
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    Description

    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management. This webb-based application allows cardiology departments to view, edit and sign the structured reports.

    Reason

    When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reporting Non-Invasive(NIV) module, "Right stenosis" appeared in the sentence display within the printed representation of the report.

    Code Info

    Software Version: RM 2.03 to 2.08, NIV 1.0

    Distribution

    Nationwide Distribution including IN, SC, OH, TX

    Quantity

    6