BEUDAMED
    FDA Enforcement Class II Terminated

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    Recall: Z-1662-2014 · Reported June 4, 2014

    Enforcement

    Recall Number
    Z-1662-2014
    Event ID
    68211
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AGFA Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2014
    Initiation Date
    April 30, 2014
    Classification Date
    May 27, 2014
    Termination Date
    September 18, 2014
    Address
    10 S Academy St, Greenville, SC, 29601-2632, United States

    Description

    IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic studies such as echocardiography.

    Reason

    Failure to effectively install and test a hotfix to correct the known software defect within the IMPAX CV 7.8 SU3-OCR Service.

    Code Info

    Model L9M21000 - Software versions: IMPAX CV 7.8 SU3/SU4 - OCR Service

    Distribution

    Distribution to SC only

    Quantity

    One