BEUDAMED
    FDA Enforcement Class II Terminated

    Merge LIS

    Recall: Z-0289-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0289-2021
    Event ID
    86449
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Merge Healthcare, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 4, 2020
    Initiation Date
    January 23, 2017
    Classification Date
    October 23, 2020
    Termination Date
    May 1, 2021
    Address
    900 Walnut Ridge Dr, N/A, Hartland, WI, 53029-8347, United States

    Description

    Merge LIS

    Reason

    A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.

    Code Info

    Merge LIS versions 4.0.1, 4.1, 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.1.5, 4.1.5 Patch 1, and 4.1.5 Patch 2

    Distribution

    Domestic Distribution Only: Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Oklahoma, Tennessee, Texas.

    Quantity

    47 units