Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/29/2017
Class lI:
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..
Recall Number Z-1517-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 9/22/2015. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
89 sites potentially have the affected accessory
DISTRIBUTION
Nationwide sites.. Military distribution was also made. There was no foreign/government distribution.
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