BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity 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-2566-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2566-2018
    Event ID
    80570
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    August 7, 2017
    Classification Date
    July 27, 2018
    Termination Date
    May 18, 2020
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity 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 identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.

    Code Info

    Software versions 10.0.6 and 10.0.7. Only customers with these 2 versions AND a license for Mammo Tracking are impacted by this recall.

    Distribution

    Nationwide distribution to CA, KY, ME, OH, OR, TN, TX, WA, WV.

    Quantity

    11 sites have potentially affected software