FDA recall record · openFDA

Murata Vios, Inc.

3 FDA recalls on record (2023–2024) — 3 device. 3 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted 1

A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios 1

During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms 1

Recalls

Vios Monitoring System Bedside Monitor Model BSM2050 Class II 2024-08-09 muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate Class II 2024-04-22 Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00 Class II 2023-06-06

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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