BEUDAMED
    FDA Enforcement Class II Terminated

    DR Systems Unity PACS software, now known as Merge Unity PACS software.

    Recall: Z-0939-2017 · Reported January 11, 2017

    Enforcement

    Recall Number
    Z-0939-2017
    Event ID
    75876
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    January 11, 2017
    Initiation Date
    October 15, 2015
    Classification Date
    December 30, 2016
    Termination Date
    April 23, 2021
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    DR Systems Unity PACS software, now known as Merge Unity PACS software.

    Reason

    The software fails to associate to the correct MG image if there are two images for the same view.

    Code Info

    Version 11.0

    Distribution

    Distribution was made to medical facilities located in MT, CA, PA, and TX.

    Quantity

    9 sites potentially have the effected software