muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
This recall is currently active, issued January 30, 2025. It was issued by Murata Vios, Inc..
- Company
- Murata Vios, Inc.
- Recall Initiated
- April 22, 2024
- Posted
- January 30, 2025
- Recall Number
- Z-1069-2025
- Quantity
- 62 units
- Firm Location
- Woodbury, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
Lot / Code Info
Soft ware version 1.57.20, UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Root Cause
Software design
Action Taken
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.