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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 catheterization laboratories

FDA Recall Z-0665-2017 · Posted None

Recalling FirmMerge Healthcare, Inc.
Recall StatusTerminated
Product CodeDQK
Date Initiated2014-04-30
Date Terminated2019-12-23
Product Quantity192 sites potentially have the affected software

Reason for Recall

The application may crash during the cath lab procedure.

Firm Action

Merge sent an Important Alert letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact Merge Support at 866-261-5761 or [email protected]. For questions regarding this recall call 877-741-5369.

Root Cause

Software design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082421HEARTSUITE HEMODYNAMICS 7.10Emageon, Inc. · 2008-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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