Merge Healthcare, Inc. - Merge Hemo - Class 2 Recall

Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module Merge Hemo (formerly named HeartSuite Hemodynamics) 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 comprises the Patient Data Module and the Merge Hemo, Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the Merge Hemo, Hemo Monitor PC via the serial interface. All data can be shown and monitored on the Merge Hemo, Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The Merge Hemo, Hemo Monitor PC is powered via the normal mains connection 230V/ 110V. The system is intended for use in hospital cardiac catheterization laboratories.
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts