Class II

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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Murata Vios, Inc. Medical Device Recall: muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate | SafeCheck