Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Change Healthcare Cardiology Hemo. Versions 14.2 Recalled by CHANGE HEALTHCARE CANADA COMPANY Due to A potential issue has been identified in Change...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CHANGE HEALTHCARE CANADA COMPANY directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CHANGE HEALTHCARE CANADA COMPANY
CHANGE HEALTHCARE CANADA COMPANY has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report