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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 January 25, 2017 · FDA recall Z-1046-2017 · Merge Healthcare
Hazard
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis. · FDA Class II
Units
188 sites potentially have the effected versions
Sold at
US Nationwide Distribution
Description
If a reader selects Multi-study review prior to the original study completing its loading process and then immediately returns to image review of the original study, it is possible that not all current images will be present for review, which could result in incorrect treatment/diagnosis.
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 →