CHANGE HEALTHCARE CANADA COMPANY: Device Recall

Recall #Z-0030-2026 · 08/13/2025

Class II: Risk

Recall Details

Recall Number: Z-0030-2026
Classification: Class II
Product Type: Device
Recalling Firm: CHANGE HEALTHCARE CANADA COMPANY
Status: Ongoing
Date Initiated: 08/13/2025
Location: Richmond, N/A, Canada
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12 programs

Reason for Recall

Due to software issue, radiology reports may not be fully displayed when viewing.

Product Description

Change Healthcare Radiology Solutions software version 14.2.2

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.

Other Recalls by CHANGE HEALTHCARE CANADA COMPANY

Class II: Risk 05/22/2025

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

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

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

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

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.

View all recalls by CHANGE HEALTHCARE CANADA COMPANY →

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.