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Merge Healthcare, Inc. recalls Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, trans
Recalled March 29, 2017 · FDA recall Z-1517-2017 · Merge Healthcare
Hazard
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation. · FDA Class II
Units
89 sites potentially have the affected software
Sold at
US Nationwide Distribution.
Description
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
Product
Merge Cardio software. Product Usage: 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 →