# FDA recall Z-1402-2025

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

## Product

Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management 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-1402-2025
- **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-1402-2025

## Citation

> AI Analytics. FDA recall Z-1402-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1402-2025. Source: US FDA. Licensed CC0.

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