Vios Monitoring System™ Model 2050

510(k) K172586

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK172586	Date22 Jun 2018Cleared	StatusActive

4 recalls · 3 ongoing · FDA

- Ongoing Z-1292-2025 FDA Class II initiated 9 Aug 2024
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.
2 recalls, same reason
- Ongoing Z-1069-2025 FDA Class II initiated 22 Apr 2024
- Completed Z-0956-2025 FDA Class II initiated 21 Jun 2021
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.
- Ongoing Z-1169-2025 FDA Class II initiated 6 Jun 2023
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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)