BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Eye Station and Merge Eye Care PACS.

    Recall: Z-1828-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1828-2017
    Event ID
    76844
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 26, 2017
    Initiation Date
    April 4, 2016
    Classification Date
    April 15, 2017
    Termination Date
    June 22, 2020
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    Merge Eye Station and Merge Eye Care PACS.

    Reason

    During an antivirus program scan of the Eye Station or Eye Care PACS, the antivirus program may detect a newly captured image to be an unwanted file and delete the image permanently.

    Code Info

    All versions

    Distribution

    Distribution was nationwide to medical facilities. Foreign distribution was made to Canada, as well as to other countries. There was also government distribution.

    Quantity

    1,627 sites potentially have the affected versions