# FDA recall Z-2403-2020

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2020-05-08.

## 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 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-2403-2020
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-08
- **Report date:** 2020-07-01
- **Termination date:** 2023-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hartland, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2403-2020

## Citation

> AI Analytics. FDA recall Z-2403-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2403-2020. Source: US FDA. Licensed CC0.

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