Class II — Murata Vios, Inc.
| Recalling firm | Murata Vios, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate |
| Quantity | 62 units |
| Distribution | Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India. |
| Initiated | 2024-04-22 |
| Classified | 2025-01-30 |
| Recall number | Z-1069-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Murata Vios, Inc. (Z-1069-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96169/
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