Drug recall
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA recall event 96169 · Class II · Murata Vios, Inc.
Key facts
| Event ID | 96169 |
|---|---|
| Recall numbers | Z-1069-2025 |
| Recalling firm | Murata Vios, Inc. |
| Product type | Devices |
| Products | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 22, 2024 |
| Report date | Feb 5, 2025 |
| City | Woodbury |
| State | MN |
| Country | United States |
| FEI number | 3015328411 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: