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Recall Observatory FDA recall evidence

Device product

Horizon Cardiology Hemo. Version 12.2.

Z-0127-2025

August 21, 2024

Class II

Product summary

Firm
CHANGE HEALTHCARE CANADA COMPANY
Event
Event 95284
Status
Ongoing
Classification
Class II
Quantity
3 systems
Official record key
device-enforcement:Z-0127-2025

Official wording

Reason: 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.

Code information: No UDI. Version 12.2

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.