Vios Monitoring System Bedside Monitor — Class II medical device recall Z-1169-2025
Ongoing recall by Murata Vios, Inc., reported 2025-02-19, distributed nationwide. A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L
| Recall number | Z-1169-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Murata Vios, Inc., Woodbury, MN, United States |
| Recall initiated | 2023-06-06 |
| Classified | 2025-02-12 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 44 systems |
| Model numbers | BSM2050 |
Product
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Reason for recall
A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by the system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1169-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.