Horizon Cardiology Hemo — Class II medical device recall Z-0127-2025
Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2024-10-23, distributed nationwide. A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead
| Recall number | Z-0127-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY, Richmond, Canada |
| Recall initiated | 2024-08-21 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, GB, IE, IL |
| Quantity | 3 systems |
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.
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-0127-2025. 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.