BEUDAMED
    FDA Enforcement Class II Terminated

    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    Recall: Z-1246-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1246-2017
    Event ID
    75914
    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
    March 1, 2017
    Initiation Date
    March 28, 2016
    Classification Date
    February 23, 2017
    Termination Date
    April 17, 2020
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    Reason

    Eye Station images were not importing properly and were imported under "unknown" due to an issue when validating patients using only an Medical Record Number (MRN)

    Code Info

    Merge ESIU: Versions 1.0, 1.1.1, 1.1.2, and 1.1.3; Merge Eye Station: All versions; Merge Eye Care PACS: Versions 4.1, 4.2, 4.3, 5.0, and 5.1

    Distribution

    Distribution was nationwide to medical facilities. There was also government and foreign distribution, including Canada.

    Quantity

    1,627 sites potentially have the affected versions