| 2024-08-09 |
Class II
|
Ongoing |
Z-1292-2025 |
Vios Monitoring System Bedside Monitor Model BSM2050 |
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Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivi… |
| 2024-04-22 |
Class II
|
Ongoing |
Z-1069-2025 |
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate |
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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 … |
| 2023-06-06 |
Class II
|
Ongoing |
Z-1169-2025 |
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00 |
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A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occ… |
| 2021-06-21 |
Class II
|
Completed |
Z-0956-2025 |
muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate |
— |
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 … |