CHANGE HEALTHCARE CANADA COMPANY
CHANGE HEALTHCARE CANADA COMPANY appears in FDA public data with 12 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0030-2026, Class II) was initiated on August 13, 2025. Its most recent 510(k) clearance was granted on November 12, 2024.
Summary
- Total Recalls
- 12
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0030-2026 | Class II | Change Healthcare Radiology Solutions software version 14.2.2 | August 13, 2025 |
| Z-2072-2025 | Class II | Change Healthcare Cardiology Hemodynamics Software | May 22, 2025 |
| Z-2071-2025 | Class II | Change Healthcare Cardiology Hemo Software | May 22, 2025 |
| Z-0127-2025 | Class II | Horizon Cardiology Hemo. Version 12.2. | August 21, 2024 |
| Z-0128-2025 | Class II | McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. | August 21, 2024 |
| Z-0126-2025 | Class II | Change 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-0551-2024 | Class II | Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Ima | November 1, 2023 |
| Z-0237-2024 | Class II | Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and inf | October 12, 2023 |
| Z-1773-2021 | Class II | Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware | April 19, 2021 |
| Z-1508-2021 | Class II | Change Healthcare Enterprise Viewer | March 17, 2021 |
| Z-0072-2021 | Class II | Change Healthcare Radiology Solutions 14.0 | August 25, 2020 |
| Z-1682-2020 | Class II | McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management | February 10, 2020 |