BEUDAMED
    FDA Enforcement Class II Ongoing

    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

    Recall: Z-1169-2025 · Reported February 19, 2025

    Enforcement

    Recall Number
    Z-1169-2025
    Event ID
    96133
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Murata Vios, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2025
    Initiation Date
    June 6, 2023
    Classification Date
    February 12, 2025
    Address
    700 Commerce Dr Ste 190, Woodbury, MN, 55125-9239, United States

    Description

    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

    Reason

    A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.

    Code Info

    All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500

    Distribution

    US Nationwide distribution in the state of NY.

    Quantity

    44 systems