Merge Hemo software recalled over injury risk

Recall date

April 30, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Merge Healthcare, Inc. recalls Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a card…

Recall number

Z-0665-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Nationwide Distribution

Why it was recalled

The application may crash during the cath lab procedure.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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