Bedside cardiac monitor system recalled for display distortion
The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.
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 of a cardiac monitoring system with a confirmed software defect causing display distortion of critical patient vital signs and ECG waveforms. This constitutes a risk-of-harm product where injury has not yet been reported, warranting classification as High per the rubric.
Plain-English summary
The muRata Vios Monitoring System Model 2050 is a bedside cardiac monitor used in healthcare settings to display and monitor patient vital signs, ECG waveforms, and cardiac activity. A software defect in version 1.57.20 has prompted an FDA Class II recall affecting 62 units distributed in New York, Texas, Ohio, Maryland, and India.
During system setup and workflow operations, patient vital signs and ECG waveforms can become distorted and will flicker or flash rapidly. This issue occurs only on the Central Station Monitor when viewing patient tiles and does not affect the bedside monitor or other points in the monitoring workflow.
Facilities using the affected equipment should contact Murata Vios, Inc. to obtain information about corrective measures or equipment replacement options.
The recalled product
- Product
- muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
- Manufacturer
- Murata Vios, Inc.
- Hazard
- display-distortion
- monitoring-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Soft ware version 1.57.20
- UDI: +B595BSM20500/$$7V1.57.20/16D20231129Y
Distribution
Distributed nationwide across the United States.
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