Murata Vios, Inc. muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Brand
Murata Vios, Inc.
Lot Codes / Batch Numbers
Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Products Sold
Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Murata Vios, Inc. is recalling muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and al due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026