FDA-Device2025-02-19Class II
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Murata Vios, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of NY.
Affected count
44 systems
Manufactured in
700 Commerce Dr Ste 190, Woodbury, MN, United States
Products
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2025Don't want to check this manually?
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