Recall Z-1069-2025 · 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 30, 2025 (initiated Apr 22, 2024) |
| Status | Open, Classified |
| 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 | Software design |
| Action | 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. |
| Quantity | 62 units |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD 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 |