Dec

2016

Merge Hemo software Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 12/7/2016
Class lI:

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
Recall Number Z-0665-2017

REASON
The application may crash during the cath lab procedure.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 11/28/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
192 sites potentially have the affected version

DISTRIBUTION
Nationwide

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Merge Hemo software Cl II

Amy Sellers

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