Change Healthcare Canada Company
Change Healthcare Canada Company holds FDA 510(k) medical device clearances, first cleared 2018, most recent 2024, with 12 FDA device recalls on record.
Top product codes for Change Healthcare Canada Company
FDA recalls by Change Healthcare Canada Company
10 most recent of 12- Z-0030-2026 — Change Healthcare Radiology Solutions software version 14.2.2
- Z-2072-2025 — Change Healthcare Cardiology Hemodynamics Software
- Z-2071-2025 — Change Healthcare Cardiology Hemo Software
- Z-0126-2025 — Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
- Z-0127-2025 — Horizon Cardiology Hemo. Version 12.2.
- Z-0128-2025 — McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
- Z-0551-2024 — Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
- Z-0237-2024 — Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
- Z-1773-2021 — Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
- Z-1508-2021 — Change Healthcare Enterprise Viewer
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Change Healthcare Canada Company
Data sourced from openFDA. This site is unofficial and independent of the FDA.