Horizon Cardiology Hemodynamic System Recalled for Configuration Error
Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall affecting a system used for critical patient monitoring decisions. Although no illnesses or injuries have been reported, the product poses a genuine risk of harm: incorrect hemodynamic calculations can lead to misdiagnosis and inappropriate treatment. This meets the rubric criterion for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Horizon Cardiology Hemo Version 12.2 is a cardiology hemodynamic monitoring system manufactured by Change Healthcare Canada Company. The FDA has issued a Class II recall for this product affecting 3 systems worldwide.
A configuration issue has been identified in the software. When the unit of measurement (UOM) setting for hemoglobin is configured in a way that differs from the user's understanding, incorrect data entry can occur. These errors lead to inaccurate hemodynamic calculations, which can potentially result in misdiagnosis and inappropriate treatment of cardiac patients.
The recalled systems have been distributed to medical facilities in the United States, Australia, Canada, Germany, Ireland, Israel, and the United Kingdom. Affected users should verify their system's unit of measurement configuration matches their facility's clinical protocols and user expectations. Contact Change Healthcare Canada Company for guidance on correcting this configuration issue.
The recalled product
- Product
- Horizon Cardiology Hemo. Version 12.2.
- Manufacturer
- CHANGE HEALTHCARE CANADA COMPANY
- Hazard
- configuration-error
- calculation-error
- misdiagnosis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- No UDI. Version 12.2
Distribution
Distributed nationwide across the United States.
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