BEUDAMED
    FDA Enforcement Class II Terminated

    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)

    Recall: Z-0227-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0227-2016
    Event ID
    72390
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Barco Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 11, 2015
    Initiation Date
    May 28, 2015
    Classification Date
    November 5, 2015
    Termination Date
    March 9, 2017
    Address
    3059 Premiere Pkwy, N/A, Duluth, GA, 30097-4905, United States

    Description

    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)

    Reason

    User settings were no longer on the monitor's memory after these systems were powered off and back on.

    Code Info

    Model MDSC-2224 (24 inch) with part numbers - K9307916 - 991932387121, K9307919 - 991932387131, K9307912 - 991932387071, K9307913 - 991932387081; Model MDSC-2226 (26 inch) with part numbers - K9307906 - 991932387011, K9307907 - 991932387031, K9307908 - 991932387021, 991932387041, 991932387061, 991932387111, 991932387141, 991932389071, 991932389081, 991932389091; Model MDSC-2242 (42 inch) with part numbers - K9307914 - 991932387091, K9307915 - 991932387101

    Distribution

    US Distribution to the states of : AZ, CA, FL, GA, IL, MA, NE, NJ, OH, OR and TX., and Internationally to Canada.

    Quantity

    462 devices in US