BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1069-2025 · Reported February 5, 2025

    Enforcement

    Recall Number
    Z-1069-2025
    Event ID
    96169
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Murata Vios, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 5, 2025
    Initiation Date
    April 22, 2024
    Classification Date
    January 30, 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 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y

    Distribution

    Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.

    Quantity

    62 units