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.On (b)(6) 2016, a customer contacted merge healthcare and stated that a diagnostic measurement taken by their modality was importing with the incorrect unit of measure within the clinical reporting tool.Due to an incorrect value displaying in the diagnostic report, there is a potential for incorrect treatment of a patient that could result in harm.(b)(4).
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