BEUDAMED
    FDA Recall Open, Classified

    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

    Recall: Z-1361-2026 · Initiated May 23, 2025

    Recall

    Recall Number
    Z-1361-2026
    Event Number
    98266
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    KQM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 23, 2025
    Posted
    February 12, 2026
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

    Reason

    This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

    Action

    All affected Customers have been contacted by a STERIS Service Technician arranging an onsite inspection of their unit(s) to locate and replace the affected MNA(s). Users are reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact Diksha Chechi, Quality Manager at 510-439-4500.

    Distribution

    US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.

    Quantity

    10 units