Company: Merge Healthcare, Inc.
Date of Enforcement Report: 7/1/2020
Class II
PRODUCT
Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release – Product Usage: VERICIS 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-2403-2020
REASON
An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. The error may reduce the sensitivity of the Z-Score in detecting an abnormality resulting in a false negative.
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc. on 5/8/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
U.S. Nationwide