BEUDAMED
    FDA Enforcement Class II Terminated

    DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    Recall: Z-1385-2017 · Reported March 8, 2017

    Enforcement

    Recall Number
    Z-1385-2017
    Event ID
    76471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 8, 2017
    Initiation Date
    April 8, 2016
    Classification Date
    March 1, 2017
    Termination Date
    March 6, 2017
    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. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.

    Reason

    The software is not adding the correct tomo image.

    Code Info

    Versions 11.0 and 11.0.1

    Distribution

    US Nationwide Distribution in the states of AL CA, CO, FL, IL, MD, MN, MT, NV, NY, OR, PA SC, TN, and TX.

    Quantity

    28 sites potentially have the affected software