Company: Merge Healthcare, Inc.
Date of Enforcement Report 12/7/2016
Class lI:
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
Recall Number Z-0665-2017
REASON
The application may crash during the cath lab procedure.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/28/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
192 sites potentially have the affected version
DISTRIBUTION
Nationwide
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