FDA-Device2017-02-01Class II

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Merge Healthcare, Inc.
Hazard

There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

Sold states
Nationwide Distribution
Affected count
242 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1091-2017

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