CHANGE HEALTHCARE CANADA COMPANY

6 FDA enforcement actions

6 Total Recalls

0 Class I

6 Class II

0 Class III

Firm Details

Product Types: device
States: N/A

All Recalls

Class II: Risk 08/13/2025 device

Due to software issue, radiology reports may not be fully displayed when viewing.
Class II: Risk 05/22/2025 device

Due to complaints, software update may cause software to unexpectedly shutdown.
Class II: Risk 05/22/2025 device

Due to complaints, software update may cause software to unexpectedly shutdown.
Class II: Risk 08/21/2024 device

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.
Class II: Risk 08/21/2024 device

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.
Class II: Risk 08/21/2024 device

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.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.