Recall Z-0956-2025 · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Murata Vios, Inc.
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
| Date | Jan 16, 2025 (initiated Jun 21, 2021) |
| Status | Completed |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 275 units |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, LA and the country of India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172586 | Vios Monitoring System™ Model 2050 Vios Medical, Inc., Jun 22, 2018 |