Horizon Cardiology Hemo. Version 12.2.
Reported: October 23, 2024 Initiated: August 21, 2024 #Z-0127-2025
Product Description
Horizon Cardiology Hemo. Version 12.2.
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.
Details
- Recalling Firm
- CHANGE HEALTHCARE CANADA COMPANY
- Units Affected
- 3 systems
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
- Location
- Richmond
Frequently Asked Questions
What product was recalled? ▼
Horizon Cardiology Hemo. Version 12.2.. Recalled by CHANGE HEALTHCARE CANADA COMPANY. Units affected: 3 systems.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0127-2025.
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