FDA-Device2016-09-28Class II

Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.

Merge Healthcare, Inc.
Hazard

Patient information in the header is only found on the first page of the report and not on the subsequent pages.

Sold states
US Nationwide Distribution
Affected count
42 sites potentially have the affected version
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2865-2016

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