BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

    Recall: Z-2652-2017 · Reported July 5, 2017

    Enforcement

    Recall Number
    Z-2652-2017
    Event ID
    77629
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 5, 2017
    Initiation Date
    December 22, 2016
    Classification Date
    June 29, 2017
    Termination Date
    August 27, 2021
    Address
    10 S Academy St, N/A, Greenville, SC, 29601-2632, United States

    Description

    IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

    Reason

    A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.

    Code Info

    Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6

    Distribution

    Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI

    Quantity

    10