Medical Device Recall: Horizon Cardiology Hemo. Version 12.2.
CHANGE HEALTHCARE CANADA COMPANY · August 21, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
3 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0127-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.