FDA-Device2025-02-05Class II
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Murata Vios, Inc.
Hazard
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in the patient tiles view and is not seen at any other point during patient monitoring & not on the Bedside Monitor.
Sold states
Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
Affected count
62 units
Manufactured in
700 Commerce Dr Ste 190, Woodbury, MN, United States
Products
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2025Don't want to check this manually?
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