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CHANGE HEALTHCARE CANADA COMPANY recalls Horizon Cardiology Hemo. Version 12.2.
Recalled October 23, 2024 · FDA recall Z-0127-2025 · CHANGE HEALTHCARE CANADA
Hazard
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. · FDA Class II
Units
3 systems
Sold at
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Description
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
Horizon Cardiology Hemo. Version 12.2.
Manufacturer(s)
CHANGE HEALTHCARE CANADA COMPANY
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →