Recall Z-2403-2020— Merge Healthcare, Inc.

Name: FDA recall Z-2403-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-08

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2020-05-08, terminated 2023-06-23. It names one FDA 510(k) clearance: K051649. 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.. 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: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-05-08
Terminated: 2023-06-23
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K051649 — VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0Camtronics Medical Systems·cleared 2005-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.