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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 Model 2050 Recalled for Display Distortion

Agency Publication Date: January 30, 2025
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Summary

Murata Vios, Inc. is recalling 62 units of the muRata Vios Monitoring System Model 2050 bedside cardiac monitor. The recall was issued because patient vital signs and ECG waveforms may flicker, flash rapidly, or become distorted on the Central Station Monitor during the initial set-up and monitoring workflow. While this issue does not occur on the bedside monitor itself, it can interfere with healthcare providers' ability to monitor patients accurately at the central station. No injuries or incidents have been reported to date.

Risk

The distorted or flickering display on the central monitor may prevent medical staff from accurately reading a patient's vital signs or heart rhythms. This could lead to delays in treatment or incorrect clinical assessments during the critical setup phase of patient monitoring.

What You Should Do

  1. This recall affects the muRata Vios Monitoring System Model 2050 bedside cardiac monitor, specifically those running software version 1.57.20.
  2. Identify affected units by checking the device label for Unique Device Identifier (UDI) +B595BSM20500/$$7V1.57.20/16D20231129Y.
  3. Stop using the recalled device immediately.
  4. Contact Murata Vios, Inc. or your authorized medical equipment distributor to arrange for a return, replacement, or technical correction to the system software.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for 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 1.57.20
Model / REF:
2050
UDI:
+B595BSM20500/$$7V1.57.20/16D20231129Y

Bedside cardiac monitor including cardiotachometer and alarm rate.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96169
Status: Active
Manufacturer: Murata Vios, Inc.
Sold By: authorized medical equipment distributors
Manufactured In: United States
Units Affected: 62 units
Distributed To: New York, Texas, Ohio, Maryland

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.