PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 7, 2016 Initiated: April 30, 2014 #Z-0665-2017

Product Description

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

Reason for Recall

The application may crash during the cath lab procedure.

Details

Recalling Firm
Merge Healthcare, Inc.
Units Affected
192 sites potentially have the affected software
Distribution
Nationwide Distribution
Location
Hartland, WI

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Merge Healthcare, Inc.. Units affected: 192 sites potentially have the affected software.
Why was this product recalled? ▼
The application may crash during the cath lab procedure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 7, 2016. Severity: Moderate. Recall number: Z-0665-2017.

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