Murata Vios Cardiac Monitor Model 2050 Displays Distorted and Flickering Waveforms
The muRata Vios Monitoring System Model 2050 central station monitor can display distorted and flickering ECG waveforms and vital signs. The issue affects only the central station display, not the bedside monitor or patient monitoring accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm product (cardiac display system) where no illnesses or injuries have been reported. The distorted and flickering waveform display could lead to misreading of critical cardiac data.
Plain-English summary
The muRata Vios Monitoring System Model 2050 is a bedside cardiac monitor that displays patient vital signs, ECG waveforms, and heart rate. The recall affects approximately 275 units globally, distributed in the United States (New York, Louisiana) and India, with software versions 1.49.02 and 1.52.00.
During the setup and workflow initialization for patient monitoring, the central station monitor (CSM) can display distorted and rapidly flickering ECG waveforms and vital signs in the patient tiles view. This issue occurs only on the CSM display in the tiles view and does not affect the bedside monitor or monitoring functions elsewhere.
The recalling firm, Murata Vios, Inc., issued this Class II medical device recall. Healthcare facilities using the affected equipment should contact the manufacturer regarding this issue and any recommended corrective actions.
The recalled product
- Product
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Manufacturer
- Murata Vios, Inc.
- Category
- Medical Device — Cardiac Monitor
- Hazard
- display-distortion
- display-flicker
Distribution
Distributed nationwide across the United States.
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