openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
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openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
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device · product 1 of 1
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
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.
These labels are deterministic app interpretations, not FDA categories.
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.
Code information
Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Distribution pattern
Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
