Recall Z-1069-2025— Murata Vios, Inc.

Name: FDA recall Z-1069-2025
Creator: U.S. Food and Drug Administration
Published: 2024-04-22

Class II · Ongoing

Class II FDA medical device recall by Murata Vios, Inc., initiated 2024-04-22. It names one FDA 510(k) clearance: K172586. Product: muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate. Reason: 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..

Recalling firm: Murata Vios, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-22
Firm location: Woodbury, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K172586 — Vios Monitoring System Model 2050Vios Medical, Inc.·cleared 2018-06-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.