Merge Healthcare Merge Application Server Software Release and Merge… — Class II medical device recall Z-2403-2020

Terminated recall by Merge Healthcare, Inc., reported 2020-07-01, distributed nationwide. An error in the calculation of the Michigan Reference Ranges can generate an inaccurate Z-Score calculation. T

Recall number	`Z-2403-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Merge Healthcare, Inc., Hartland, WI, United States
Recall initiated	2020-05-08
Classified	2020-06-19
Reported by FDA	2020-07-01
Terminated	2023-06-23
Distributed	Nationwide (US)
Quantity	62 units
UPC / GTIN / UDI-DI	`00842000100041`, `00842000100416`, `00842000100751`

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2403-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.