BEUDAMED
    FDA Recall 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 · Initiated April 4, 2016

    Recall

    Recall Number
    Z-1681-2017
    Event Number
    76309
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    NFJ
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    April 4, 2016
    Posted
    March 13, 2017
    Terminated
    June 22, 2020
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    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.

    Action

    The recalling firm issued a letter dated 3/28/2016 via e-mail the week of 4/4/2016. If no email address was available, the letters were issued via certified mail.

    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