BEUDAMED
    FDA Recall Completed

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

    Recall: Z-0956-2025 · Initiated June 21, 2021

    Recall

    Recall Number
    Z-0956-2025
    Event Number
    96078
    Firm
    Murata Vios, Inc.
    FEI Number
    3015328411
    Product Code
    DRT
    Status
    Completed
    Root Cause
    Device Design
    Initiated
    June 21, 2021
    Posted
    January 16, 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 Vios notified their consignees via email on 06/21/2021. The notice explained the issue and provided workflow guidance to prevent the problem from occurring while a software update was being created. The firm followed up with another email on 08/24/2021 informing the consignees that the software update was ready for deployment and to request scheduling an appointment for the upgrade.

    Distribution

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

    Quantity

    275 units