BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1426-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1426-2017
    Event ID
    76541
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 15, 2017
    Initiation Date
    April 8, 2016
    Classification Date
    March 9, 2017
    Termination Date
    March 17, 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

    Reason

    Reports were missing demographic header information when they were faxed to referring physicians.

    Code Info

    Version 11.0

    Distribution

    US Distribution was made to medical facilities in CA, MT, PA, and TX. There was no foreign/military/government distribution.

    Quantity

    9 sites potentially have the affected version