BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

    Recall: Z-1681-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1681-2017
    Event ID
    76309
    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 5, 2017
    Initiation Date
    April 4, 2016
    Classification Date
    March 24, 2017
    Termination Date
    June 22, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

    Reason

    The system will completely stop allowing the downloading or acquisition of new images due to incompatible software application versions.

    Code Info

    All versions of Eye Care PACS, Eye Station, and ESIU.

    Distribution

    Distribution was made to medical facilities nationwide. Government distribution was made. Foreign distribution was made to Canada, as well as other countries. There was no military distribution.

    Quantity

    1,627 sites potentially have the affected software