Company: Merge Healthcare, Inc.
Date of Enforcement Report 12/21/2016
Class lI:
PRODUCT
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems 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-0730-2017
REASON
Reporting feature times out after inactivity for more than an hour sending the user back to the study list, which causes all reporting data being entered to be lost.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 10/1/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
116 sites potentially have the effected versions
DISTRIBUTION
Nationwide
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