BEUDAMED
    FDA Recall 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 · Initiated March 28, 2016

    Recall

    Recall Number
    Z-1246-2017
    Event Number
    75914
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    NFJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 28, 2016
    Terminated
    April 17, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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)

    Action

    The recalling firm issued a letter dated 3/28/2016 via e-mail. If no email address was available, the letters were issued via certified mail. A follow-up letter dated 7/11/2016 was also issued.

    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