Device 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
Z-0665-2017
Product summary
- Event
- Event 75564
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 sites potentially have the affected software
- Official record key
device-enforcement:Z-0665-2017
Official wording
Reason: The application may crash during the cath lab procedure.
Code information: Versions 9.10, 9.20.0, 9.20.2, 9.30.0, 9.40.0, 9.40.1, and 9.40.2 with Windows 7 Operating System
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The application may crash during the cath lab procedure.