Murata Vios, Inc.
4 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (4)
- Inspections (2)
Devices registered here (2)
- Medical Device Data SystemProduct code OUG (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6310
- Display, Cathode-Ray Tube, MedicalProduct code DXJ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2450
Recalls & enforcement
- Class IIOngoing2024-08-09Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues.
- Class IIOngoing2024-04-22During 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 s…
- Class IIOngoing2023-06-06A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
- Class IICompleted2021-06-21During 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 s…
FDA inspections (2)
- VAI2024-12-11Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- NAI2020-02-20No Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Murata Vios, Inc. (FEI 3015328411) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015328411-murata-vios-inc/
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