Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0665-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 30, 2014

Date Posted: December 7, 2016

Recall Number: Z-0665-2017

Event ID: 75564

Reason for Recall:

The application may crash during the cath lab procedure.

Status: Terminated

Product Quantity: 192 sites potentially have the affected software

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

Voluntary or Mandated:

Voluntary: Firm initiated