Merge Healthcare, Inc. recalls Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Relea…

Recall date

May 8, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2403-2020

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

US Nationwide distribution including in the states of IL, TX, OR, AZ, OH, TN, CA, UT, MO, GA, NM, OK, VA, IN, CT, and VT.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.