BEUDAMED
    FDA Enforcement Class II Completed

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    Recall: Z-0956-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0956-2025
    Event ID
    96078
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Murata Vios, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 22, 2025
    Initiation Date
    June 21, 2021
    Classification Date
    January 16, 2025
    Address
    700 Commerce Dr Ste 190, Woodbury, MN, 55125-9239, United States

    Description

    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

    Reason

    During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.

    Code Info

    Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K

    Distribution

    Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.

    Quantity

    275 units