BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    Recall: Z-1069-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1069-2013
    Event ID
    64654
    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
    April 1, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    Description

    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management.

    Reason

    Software design error in IMPAX CV 7.8 SU3

    Code Info

    Softwaer version: IMPAX CR 7.8 SU3 Optical Character Recognition (OCR) Service

    Distribution

    Distribute in the state of FL and KY

    Quantity

    2