Class II — CHANGE HEALTHCARE CANADA COMPANY
| Recalling firm | Change Healthcare Canada Company |
|---|---|
| Registered facility | CHANGE HEALTHCARE CANADA COMPANY (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1. |
| Quantity | 221 systems |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom. |
| Initiated | 2024-08-21 |
| Classified | 2024-10-17 |
| Recall number | Z-0126-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CHANGE HEALTHCARE CANADA COMPANY (Z-0126-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95284/
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