FDA-Device2017-03-29Class II

Merge Cardio software.

Merge Healthcare, Inc.
Hazard

Cardio study list does not show STAT studies without refreshing.

Sold states
Distribution was nationwide to medical facilities. There was also military distribution. There was no foreign/government distribution.
Affected count
217 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Cardio software.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1486-2017

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