BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    Recall: Z-2184-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2184-2012
    Event ID
    62646
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    July 27, 2012
    Classification Date
    August 10, 2012
    Termination Date
    January 13, 2015
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    Description

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    Reason

    Content entered into the "Conclusions" free text box on the Report Writer screen was not represented on the final printed report.

    Code Info

    Model # L9M2100 - All Software versions of IMPAX CV Reporting

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada

    Quantity

    280