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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 Monitoring System Recalled for Display Distortion and Flickering

Agency Publication Date: January 16, 2025
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Summary

Murata Vios, Inc. is recalling 275 units of the muRata Vios Monitoring System Model 2050 bedside cardiac monitor. The recall was initiated because patient vital signs and heart rhythm (ECG) waveforms can become distorted, flicker, or flash rapidly on the Central Station Monitor during setup. While this display issue occurs on the central viewing station used by staff, the data remains unaffected on the actual bedside monitor.

Risk

The flickering and distortion of critical patient data could lead medical staff to misinterpret vital signs or experience delays in providing treatment. No injuries or incidents have been reported to date.

What You Should Do

  1. This recall affects the muRata Vios Monitoring System Model 2050 bedside cardiac monitors equipped with software versions 1.49.02 and 1.52.00.
  2. Identify affected devices by checking the software version and UDI on the device label or system settings screen. The affected UDIs are +B595BSM20500/$$7V1.49.02/16D20200504S and +B595BSM20500/$$7V1.52.00/16D20210305K.
  3. Stop using the recalled device. Contact Murata Vios, Inc. or your authorized distributor to arrange for a software update, repair, or replacement of the system.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 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: muRata Vios Monitoring System Model 2050
Variants: Software version 1.49.02, Software version 1.52.00
Model / REF:
2050
UDI:
+B595BSM20500/$$7V1.49.02/16D20200504S
+B595BSM20500/$$7V1.52.00/16D20210305K

Bedside cardiac monitor including cardiotachometer and alarm rate functions.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96078
Status: Resolved
Manufacturer: Murata Vios, Inc.
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 275 units
Distributed To: New York, Louisiana
Agency Last Updated: May 16, 2025

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.