Company: Merge Healthcare, Inc.
Date of Enforcement Report 1/25/2017
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-1046-2017
REASON
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.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 3/28/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
188 sites
DISTRIBUTION
Nationwide
___________________________________
