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Recall Observatory FDA recall evidence

Device product

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

Z-1169-2025

June 06, 2023

Class II

Product summary

Firm
Murata Vios, Inc.
Event
Event 96133
Status
Ongoing
Classification
Class II
Quantity
44 systems
Official record key
device-enforcement:Z-1169-2025

Official wording

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.

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

Distribution pattern: US Nationwide distribution in the state of NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.