Official recall record
Horizon Cardiology Hemo. Version 12.2.
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-08-21
- Country of alert
- Canada
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- CHANGE HEALTHCARE CANADA COMPANY
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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