BEUDAMED
    FDA Recall Open, Classified

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    Recall: Z-1854-2022 · Initiated July 27, 2022

    Recall

    Recall Number
    Z-1854-2022
    Event Number
    90807
    FEI Number
    3013691682
    Product Code
    DXJ
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    July 27, 2022
    Posted
    September 29, 2022
    Address
    BARCO NV Beneluxpark 8500 Kortrijk Bulgaria

    Description

    Barco Medical Network Adapter, MNA-240, part of the NexxisOR system, Model Numbers: a) K9303078A, b) K9303097A

    Reason

    installation issues

    Action

    Barco NV began notifying its consignees on about August 29, 2022, via email, about the device malfunction and stated that they would be providing an updated instructions for use (IFU). The firm followed with a Field Safety Action, via email on the same day, which described the issue, potential risks and a copy of the updated IFU. The letter requested the following: 1. Fill out and send back Response Form 1 to Barco Key Account Manager after receipt of this Notice. 2. Read the updated installation instructions, including the potential risk of wrong installation. 3. Inform relevant partners and ask them to evaluate if their installations must be adapted. 4. Fill out and send back Response Form 2 to Barco Key Account Manager after completion of the actions.

    Distribution

    US Nationwide distribution in the states of FL, IL, NJ.

    Quantity

    169 devices