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Change Healthcare Canada Company FDA Recalls

10 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Change Healthcare Radiology Solutions software version 14.2.2Class IIAug 13, 2025Due to software issue, radiology reports may not be fully di
Change Healthcare Cardiology Hemo SoftwareClass IIMay 22, 2025Due to complaints, software update may cause software to une
Change Healthcare Cardiology Hemodynamics SoftwareClass IIMay 22, 2025Due to complaints, software update may cause software to une
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.Class IIAug 21, 2024A potential issue has been identified in Change Healthcare C
Horizon Cardiology Hemo. Version 12.2.Class IIAug 21, 2024A potential issue has been identified in Change Healthcare C
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.Class IIAug 21, 2024A potential issue has been identified in Change Healthcare C
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.Class IINov 1, 2023Under certain circumstances, information from HL7 messages r
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management Class IIOct 12, 2023Change Healthcare has identified a software issue where Chan
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D dClass IIApr 19, 2021A software defect was identified where the Image Styles defi
Change Healthcare Enterprise ViewerClass IIMar 17, 2021Change Healthcare has identified an intermittent software de

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