muRata Vios Monitoring System Model 2050 — Class II medical device recall Z-0956-2025
Completed recall by Murata Vios, Inc., reported 2025-01-22, distributed nationwide. During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG
| Recall number | Z-0956-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Murata Vios, Inc., Woodbury, MN, United States |
| Recall initiated | 2021-06-21 |
| Classified | 2025-01-16 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 275 units |
| Model numbers | 2050 |
Product
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Reason for recall
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.
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-0956-2025. 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.