FDA-Device2016-12-07Class II
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterizat
Merge Healthcare, Inc.
Hazard
The application may crash during the cath lab procedure.
Sold states
Nationwide Distribution
Affected count
192 sites potentially have the affected software
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterization laboratories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0665-2017Don't want to check this manually?
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