muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
FDA device recall Z-1069-2025 · posted 2025-01-30 · Open, Classified
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 sent an email to its consignees on 04/22/2024 to inform them of the issue and provide the correct workflow to address the issue. The email further requested the posting of the workflow guidance in nurse training areas, add to in-services, and other recurrent training for Vios Monitoring. If the flickering issue is observed on the central station monitor, immediately begin using the bedside tablet for all patient monitoring and alarm management and contact Vios Support at 866-990-1434.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- DRT
- Quantity affected
- 62 units
- Distribution
- Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
- Date initiated
- 2024-04-22
- Date posted
- 2025-01-30
- 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 |