BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1069-2025 · Initiated April 22, 2024

    Recall

    Recall Number
    Z-1069-2025
    Event Number
    96169
    Firm
    Murata Vios, Inc.
    FEI Number
    3015328411
    Product Code
    DRT
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    April 22, 2024
    Posted
    January 30, 2025
    Address
    700 Commerce Dr, Ste 190, Woodbury, MN, 55125-9239

    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.

    Action

    Murata sent an email to its consignees on 04/22/2024 to inform them of the issue and provide the correct workflow to address the issue. The email further requested the posting of the workflow guidance in nurse training areas, add to in-services, and other recurrent training for Vios Monitoring. If the flickering issue is observed on the central station monitor, immediately begin using the bedside tablet for all patient monitoring and alarm management and contact Vios Support at 866-990-1434.

    Distribution

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

    Quantity

    62 units