FDA recall Z-1169-2025

Murata Vios, Inc. · Class II · device

Product

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.

Distribution

US Nationwide distribution in the state of NY.

Key facts

Status
Ongoing
Initiation date
2023-06-06
Report date
2025-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woodbury, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1169-2025