Vios Monitoring System Bedside Monitor Model BSM2050
FDA device recall Z-1292-2025 · posted 2025-03-06 · Open, Classified
Recall details
- Recalling firm
- Murata Vios, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- DRT
- Quantity affected
- 50
- Distribution
- US Nationwide distribution in the states of Florida, Louisiana, Maryland, Montana, New York, Ohio, and Texas.
- Date initiated
- 2024-08-09
- Date posted
- 2025-03-06
- Location
- Woodbury, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Vios Monitoring Systemâ„¢ Model 2050 (K172586) | Vios Medical, Inc. | 2018-06-22 |