Change Healthcare Canada recalls
Change Healthcare Canada appears in 12 official U.S. recall notices indexed by RecallRadar, most recently on 2025-10-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 12 |
|---|---|
| Published | 2020-04-15 to 2025-10-08 |
| By agency | FDA Device (12) |
| By classification | Class II (12) |
| By status | ongoing (11), terminated (1) |
| Distribution named in notices | AK, AZ, CA, FL, HI, IA, IL, IN, KY, MI, MS, NE, NY, OH, PA, TX, US, VT, WA, WI, WV, WY |
Recalls
- Change Healthcare Radiology Solutions software version 14.2.2
FDA Device · Class II · 2025-10-08 · Change Healthcare Canada
Reason: Due to software issue, radiology reports may not be fully displayed when viewing. - Change Healthcare Cardiology Hemodynamics Software
FDA Device · Class II · 2025-07-09 · Change Healthcare Canada
Reason: Due to complaints, software update may cause software to unexpectedly shutdown. - Change Healthcare Cardiology Hemo Software
FDA Device · Class II · 2025-07-09 · Change Healthcare Canada
Reason: Due to complaints, software update may cause software to unexpectedly shutdown. - Change Healthcare Cardiology Hemo
FDA Device · Class II · 2024-10-23 · Change Healthcare Canada
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. T… - McKesson Cardiology Hemo
FDA Device · Class II · 2024-10-23 · Change Healthcare Canada
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. T… - Horizon Cardiology Hemo
FDA Device · Class II · 2024-10-23 · Change Healthcare Canada
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. T… - Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS
FDA Device · Class II · 2023-12-20 · Change Healthcare Canada
Reason: Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study. - Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software
FDA Device · Class II · 2023-11-15 · Change Healthcare Canada
Reason: 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. - Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and…
FDA Device · Class II · 2021-06-09 · Change Healthcare Canada
Reason: A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV. - Change Healthcare Enterprise Viewer
FDA Device · Class II · 2021-05-05 · Change Healthcare Canada
Reason: Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display. - Change Healthcare Radiology Solutions 14.0
FDA Device · Class II · 2020-10-14 · Change Healthcare Canada
Reason: Software defect which may potentially result in one or more images missing in a study - McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
FDA Device · Class II · 2020-04-15 · Change Healthcare Canada
Reason: 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