muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA device recall Z-0956-2025 · posted 2025-01-16 · Completed
Recall details
- Recalling firm
- Murata Vios, Inc.
- 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.
- Action taken
- Murata Vios notified their consignees via email on 06/21/2021. The notice explained the issue and provided workflow guidance to prevent the problem from occurring while a software update was being created. The firm followed up with another email on 08/24/2021 informing the consignees that the software update was ready for deployment and to request scheduling an appointment for the upgrade.
- Root cause
- Device Design
- Status
- Completed
- Product code
- DRT
- Quantity affected
- 275 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, LA and the country of India.
- Date initiated
- 2021-06-21
- Date posted
- 2025-01-16
- 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 |