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CHANGE HEALTHCARE CANADA Recalls
12 recalls on record · April 15, 2020 to October 8, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 8, 2025Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions software version 14.2.2
Hazard: Due to software issue, radiology reports may not be fully displayed when viewing.
July 9, 2025Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Cardiology Hemodynamics Software
Hazard: Due to complaints, software update may cause software to unexpectedly shutdown.
July 9, 2025Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Cardiology Hemo Software
Hazard: Due to complaints, software update may cause software to unexpectedly shutdown.
October 23, 2024Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Hazard: 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.
October 23, 2024Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Horizon Cardiology Hemo. Version 12.2.
Hazard: 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.
October 23, 2024Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Hazard: 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.
December 20, 2023Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Hazard: Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
November 15, 2023Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management
Hazard: Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.
June 9, 2021Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D d
Hazard: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
May 5, 2021Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Enterprise Viewer
Hazard: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
October 14, 2020Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions 14.0
Hazard: Software defect which may potentially result in one or more images missing in a study
April 15, 2020Medical DevicesFDA
CHANGE HEALTHCARE CANADA COMPANY recalls McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
Hazard: Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format