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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 62
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
Related recalls
Same manufacturer · Murata Vios, Inc.
See all →- ModerateVios bedside monitor batteries may deplete during storage
FDA (Devices) · 2025-03-12
- HighVios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings
FDA (Devices) · 2025-02-19
- HighMurata Vios Cardiac Monitor Model 2050 Displays Distorted and Flickering Waveforms
FDA (Devices) · 2025-01-22
Same hazard · display distortion
See all →- HighGE Healthcare X-Ray Systems Affected by Display Image Distortion Defect
FDA (Devices) · 2021-06-23
Similar recalls
- HighMurata Vios Cardiac Monitor Model 2050 Displays Distorted and Flickering Waveforms
FDA (Devices) · 2025-01-22
- HighVios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings
FDA (Devices) · 2025-02-19
- HighCardiac Monitoring System Software Error May Disable Device
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- ModerateVios bedside monitor batteries may deplete during storage
FDA (Devices) · 2025-03-12
- HighMindray DPM Central Monitoring System Recalled for ECG Waveform Anomaly
FDA (Devices) · 2013-02-20
- HighPhilips Xper Flex Cardio Physiomonitoring System Recalled for Display Errors
FDA (Devices) · 2018-12-26