# FDA recall Z-1399-2025

> **Merge Healthcare, Inc.** · Class II · device recall initiated 2025-02-19.

## Product

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.

## Reason for recall

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may be inconsistent with the associated primitive measurements in the final patient report.

## Distribution

US

## Key facts

- **Recall number:** Z-1399-2025
- **Recalling firm:** Merge Healthcare, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-19
- **Report date:** 2025-03-26

- **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-1399-2025

## Citation

> AI Analytics. FDA recall Z-1399-2025. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1399-2025. Source: US FDA. Licensed CC0.

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