FDA-Device2016-12-21Class II
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Merge Healthcare, Inc.
Hazard
If images are sent without an order in the system, they will be matched with the latest order on the current patient/modality matching potentially resulting in the matching of the report to the incorrect accession number (but still associated to the correct patient).
Sold states
Nationwide Distribution
Affected count
198 sites potentially have the effected versions
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0729-2017Don't want to check this manually?
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