BEUDAMED
    FDA Recall 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 · Initiated May 28, 2015

    Recall

    Recall Number
    Z-0227-2016
    Event Number
    72390
    Firm
    Barco Inc.
    FEI Number
    3004578804
    Product Code
    KQM
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 28, 2015
    Posted
    November 5, 2015
    Terminated
    March 9, 2017
    Address
    3059 Premiere Pkwy, Duluth, GA, 30097-4905

    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.

    Action

    Barco sent an "Urgent Medical Device Correction Notice" dated May 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice contained "Interim Corrective Action" and information about a "Final Corrective Action". The notice included a reply notice to be sent back to Barco and also requested a sub-recall. For further questions, please call (678) 475-8156.

    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