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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Murata Vios Bedside Monitors Recalled for Incorrect Sensor Warning

Agency Publication Date: February 12, 2025
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Summary

Murata Vios, Inc. is recalling 44 Vios Monitoring System Bedside Monitors (Model BSM2050) because a defect in the pulse oximeter sensor can cause the system to display an incorrect "Pulse Ox Sensor Off" warning. This recall affects devices running software versions 1.54.20 and 1.56.00. While no injuries have been reported, the failure could lead to monitoring errors.

Risk

The sensor failure causes the system to display incorrect status warnings, which may result in a lack of accurate patient monitoring or a delay in necessary medical intervention.

What You Should Do

  1. This recall affects the Vios Monitoring System Bedside Monitor (Model BSM2050) with software versions 1.54.20 or 1.56.00 and UDI-DI B595BSM20500.
  2. Stop using the recalled device immediately to ensure patient safety.
  3. Contact Murata Vios, Inc. or your equipment distributor to arrange for a return, replacement, or necessary software correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Vios Monitoring System Bedside Monitor
Variants: Software Version 1.54.20, Software Version 1.56.00
Model / REF:
BSM2050
UDI:
B595BSM20500

Affected by a premature failure condition with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96133
Status: Active
Manufacturer: Murata Vios, Inc.
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 44 systems
Distributed To: New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.