01

Jul

2020

Recall – Clinical information system incorrectly detects abnormality

recall, softwareerror

0

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

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