Murata Vios, Inc.: Device Recall
Recall #Z-1069-2025 · 04/22/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1069-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Murata Vios, Inc.
- Status
- Ongoing
- Date Initiated
- 04/22/2024
- Location
- Woodbury, MN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62 units
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.
Product Description
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
Distribution Pattern
Worldwide - US Nationwide distribution in the states of NY, TX, OH, MD and the country of India.
Other Recalls by Murata Vios, Inc.
- Class II: Risk 08/09/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.