CHANGE HEALTHCARE CANADA COMPANY: Device Recall
Recall #Z-0127-2025 · 08/21/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0127-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- CHANGE HEALTHCARE CANADA COMPANY
- Status
- Ongoing
- Date Initiated
- 08/21/2024
- Location
- Richmond, Canada
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 systems
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.
Product Description
Horizon Cardiology Hemo. Version 12.2.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Other Recalls by CHANGE HEALTHCARE CANADA COMPANY
- Class II: Risk 08/13/2025
- Class II: Risk 05/22/2025
- Class II: Risk 05/22/2025
- Class II: Risk 08/21/2024
- Class II: Risk 08/21/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.