muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
This recall has been completed (originally issued January 16, 2025).
- Company
- Murata Vios, Inc.
- Recall Initiated
- June 21, 2021
- Posted
- January 16, 2025
- Recall Number
- Z-0956-2025
- Quantity
- 275 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, LA and the country of India.
Lot / Code Info
Soft ware version 1.49.02 UDI: +B595BSM20500/\$\$7V1.49.02/16D20200504S and Software version 1.52.00 UDI: +B595BSM20500/\$\$7V1.52.00/16D20210305K
Root Cause
Device Design
Action Taken
Murata Vios notified their consignees via email on 06/21/2021. The notice explained the issue and provided workflow guidance to prevent the problem from occurring while a software update was being created. The firm followed up with another email on 08/24/2021 informing the consignees that the software update was ready for deployment and to request scheduling an appointment for the upgrade.