BEUDAMED
    FDA Enforcement Class II Terminated

    Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications

    Recall: Z-0664-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0664-2017
    Event ID
    75334
    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
    December 7, 2016
    Initiation Date
    January 30, 2016
    Classification Date
    November 28, 2016
    Termination Date
    March 20, 2019
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347, United States

    Description

    Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications

    Reason

    Communication protocols interfacing with the affected software version with some select instruments were not properly handled, preventing data captured by these instructions to be processed by the rest of the LIS software.

    Code Info

    Version 1.0

    Distribution

    Nationwide Distribution

    Quantity

    324 sites potentially have the affected version