FDA-Device2024-10-23Class II
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
CHANGE HEALTHCARE CANADA COMPANY
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Affected count
35 systems
Manufactured in
10711 Cambie Rd Suite 130, Richmond, Canada
Products
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0128-2025Don't want to check this manually?
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