BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems 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-2551-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2551-2016
    Event ID
    74846
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 24, 2016
    Initiation Date
    July 23, 2015
    Classification Date
    August 16, 2016
    Termination Date
    October 7, 2016
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems 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 unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm.

    Code Info

    Version 11.0

    Distribution

    US Distribution to states of: CA, PA, TX, and MT.

    Quantity

    9 sites potentially have the affected version