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Merge Healthcare, Inc. recalls Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a c
Recalled December 7, 2016 · FDA recall Z-0665-2017 · Merge Healthcare
Hazard
The application may crash during the cath lab procedure. · FDA Class II
Units
192 sites potentially have the affected software
Sold at
Nationwide Distribution
Description
The application may crash during the cath lab procedure.
Product
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
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →