RegWardenFDA facility compliance records
Facility

Murata Vios, Inc.

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2020: 1 inspections; 2021: 1 recalls; 2023: 1 recalls; 2024: 2 recalls, 1 inspections20172018201912020120212022120233202420252026
  • Recalls (4)
  • Inspections (2)

Devices registered here (2)

Recalls & enforcement

  • Class IIOngoing2024-08-09
    Batteries 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 IIOngoing2024-04-22
    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 s…
  • Class IIOngoing2023-06-06
    A 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 IICompleted2021-06-21
    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 s…

FDA inspections (2)

  • VAI2024-12-11
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2020-02-20
    No 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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