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CHANGE HEALTHCARE CANADA COMPANY

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0030-2026Class IIChange Healthcare Radiology Solutions software version 14.2.2August 13, 2025
Z-2072-2025Class IIChange Healthcare Cardiology Hemodynamics SoftwareMay 22, 2025
Z-2071-2025Class IIChange Healthcare Cardiology Hemo SoftwareMay 22, 2025
Z-0126-2025Class IIChange Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.August 21, 2024
Z-0127-2025Class IIHorizon Cardiology Hemo. Version 12.2.August 21, 2024
Z-0128-2025Class IIMcKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.August 21, 2024
Z-0551-2024Class IIChange Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus ImaNovember 1, 2023
Z-0237-2024Class IIChange Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and infOctober 12, 2023
Z-1773-2021Class IIChange Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardwareApril 19, 2021
Z-1508-2021Class IIChange Healthcare Enterprise ViewerMarch 17, 2021
Z-0072-2021Class IIChange Healthcare Radiology Solutions 14.0August 25, 2020
Z-1682-2020Class IIMcKesson Cardiology ECG Management, Change Healthcare Cardiology ECG ManagementFebruary 10, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K241981Change Healthcare Stratus Imaging PACSNovember 12, 2024
K210719Change Healthcare Anatomical AIJuly 20, 2021
K181185Change Healthcare Enterprise ViewerAugust 29, 2018