Recall Z-1292-2025 · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Murata Vios, Inc.
Vios Monitoring System Bedside Monitor Model BSM2050
| Date | Mar 6, 2025 (initiated Aug 9, 2024) |
| Status | Open, Classified |
| Reason | Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues. |
| Root cause | Labeling design |
| Action | The firm sent a single page of instructions to customers on August 9, 2024 via email. Customers were informed that tablets should remain plugged into a wall outlet when the tablet is not in use. The tablet battery should not be allowed to fully deplete at any time during patient monitoring or when not in use. |
| Quantity | 50 |
| Distribution | US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas. |
| 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 |