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Merge Healthcare, Inc. recalls Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive
Recalled December 21, 2016 · FDA recall Z-0729-2017 · Merge Healthcare
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). · FDA Class II
Units
198 sites potentially have the effected versions
Sold at
Nationwide Distribution
Description
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).
Product
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.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →