# FDA recall Z-0127-2025

> **CHANGE HEALTHCARE CANADA COMPANY** · Class II · device recall initiated 2024-08-21.

## Product

Horizon Cardiology Hemo. Version 12.2.

## Reason for recall

A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.

## Key facts

- **Recall number:** Z-0127-2025
- **Recalling firm:** CHANGE HEALTHCARE CANADA COMPANY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-21
- **Report date:** 2024-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2025

## Citation

> AI Analytics. FDA recall Z-0127-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0127-2025. Source: US FDA. Licensed CC0.

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