Z-1169-2025 Class II Ongoing

Recalled by Murata Vios, Inc. — Woodbury, MN

Recall Details

Product Type
Devices
Report Date
February 19, 2025
Initiation Date
June 6, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
44 systems

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.

Distribution Pattern

US Nationwide distribution in the state of NY.

Code Information

All systems with Software Version Numbers 1.54.20 and 1.56.00 affected; UDI-DI: B595BSM20500