Murata Vios, Inc. recalls muRata Vios Monitoring System Model 2050

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.

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

Murata sent an email to its consignees on 04/22/2024 to inform them of the issue and provide the correct workflow to address the issue. The email further requested the posting of the workflow guidance in nurse training areas, add to in-services, and other recurrent training for Vios Monitoring. If the flickering issue is observed on the central station monitor, immediately begin using the bedside tablet for all patient monitoring and alarm management and contact Vios Support at 866-990-1434.

• FDA enforcement recordOfficial FDA database entry for Z-1069-2025
• FDA 510(k) clearance · K172586The device's official FDA premarket clearance record
• FDA device classification · DRTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.2300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Murata Vios, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.