FDAFDA · Food and drugs·Recall number Z-0127-2025
Horizon Cardiology Hemo. Version 12.2.
Published October 23, 2024 · Recall initiated: August 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
- Lot
- No UDI. Version 12.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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