Horizon Cardiology Hemo. Version 12.2 recall
Horizon Cardiology Hemo. Version 12.2.
Why was Horizon Cardiology Hemo. Version 12.2 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
No UDI. Version 12.2
- Product
- Horizon Cardiology Hemo. Version 12.2.
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Quantity
- 3 systems
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
- Recall date
- October 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)