Medical Device Recall: muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Murata Vios, Inc. · April 22, 2024
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
States Affected
NATIONWIDE
Quantity Affected
62 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1069-2025
Status: ongoing
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