Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings
Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a premature sensor failure that could result in incorrect monitoring alerts. While no illnesses or injuries have been reported, the risk-of-harm is present because incorrect warnings could mask actual device malfunctions during patient monitoring.
Plain-English summary
Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, with Software Versions 1.54.20 and 1.56.00. The recall affects 44 systems that were distributed in the United States.
The company identified a premature failure condition in the L2050R pulse oximeter SpO2 sensor, which connects to the L2050G Vios chest sensor device. When the sensor fails, the system displays a "Pulse Ox Sensor Off" warning, but this warning may not accurately reflect the nature of the sensor failure and could cause providers to misunderstand the underlying device malfunction.
Healthcare facilities and clinicians using the affected systems should review patient monitoring records for any instances where the pulse oximeter sensor failed or warnings were displayed. Contact Murata Vios, Inc. for guidance on upgrading to a corrected software version or for device replacement.
The recalled product
- Product
- Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
- Manufacturer
- Murata Vios, Inc.
- Hazard
- sensor-failure
- incorrect-alert
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All systems with Software Version Numbers 1.54.20 and 1.56.00 affected
- UDI-DI: B595BSM20500
Distribution
Distributed nationwide across the United States.
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