BEUDAMED
    FDA Enforcement Class II Ongoing

    Vios Monitoring System Bedside Monitor Model BSM2050

    Recall: Z-1292-2025 · Reported March 12, 2025

    Enforcement

    Recall Number
    Z-1292-2025
    Event ID
    96252
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Murata Vios, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 12, 2025
    Initiation Date
    August 9, 2024
    Classification Date
    March 6, 2025
    Address
    700 Commerce Dr Ste 190, Woodbury, MN, 55125-9239, United States

    Description

    Vios Monitoring System Bedside Monitor Model BSM2050

    Reason

    Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.

    Code Info

    1.56.01 UDI: +B595BSM20500/$$7V1.56.01/16D20230630S 1.57.20 UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y Software Versions 1.56.01 and 1.57.20

    Distribution

    US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.

    Quantity

    50