Woodbury, MN, United States
Murata Vios, Inc. recalls
4 recalls recorded since 2018, most recently on 9 August 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 August 2024
- 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.
- Distribution
- US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1292-2025
- Vios Monitoring System Bedside Monitor Model BSM2050
Ongoing Class II Medical devices
- Recall started
- 22 April 2024
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1069-2025
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Ongoing Class II Medical devices
- Recall started
- 6 June 2023
- Reason
- A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
- Distribution
- US Nationwide distribution in the state of NY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1169-2025
- Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Completed Class II Medical devices
- Recall started
- 21 June 2021
- 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.
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0956-2025
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.