PlainRecalls
FDA Devices Moderate Class II Ongoing

Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

Reported: February 19, 2025 Initiated: June 6, 2023 #Z-1169-2025

Product Description

Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

Reason for Recall

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.

Details

Recalling Firm
Murata Vios, Inc.
Units Affected
44 systems
Distribution
US Nationwide distribution in the state of NY.
Location
Woodbury, MN

Frequently Asked Questions

What product was recalled?
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00. Recalled by Murata Vios, Inc.. Units affected: 44 systems.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 19, 2025. Severity: Moderate. Recall number: Z-1169-2025.