Murata Vios, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
2
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1292-2025Class IIVios Monitoring System Bedside Monitor Model BSM2050August 9, 2024
Z-1069-2025Class IImuRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alApril 22, 2024
Z-1169-2025Class IIVios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00June 6, 2023
Z-0956-2025Class IImuRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alJune 21, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K241728Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 205January 23, 2025
K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMarch 22, 2024