Z-0127-2025 Class II Ongoing
FDA device recall Z-0127-2025 was initiated by CHANGE HEALTHCARE CANADA COMPANY on August 21, 2024 and is designated Class II. 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 inappro… The recall status is ongoing. Affected quantity: 3 systems.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- August 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 systems
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
Code Information
No UDI. Version 12.2