Recall Register

CHANGE HEALTHCARE CANADA COMPANY: FDA recalls

FDA enforcement reports name CHANGE HEALTHCARE CANADA COMPANY as the recalling firm in 9 events. The events have 12 product records. The recalls started from 2020 to 2025. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

9 events, newest first.

FDA enforcement events of CHANGE HEALTHCARE CANADA COMPANY
InitiatedProduct (first record)TypeClassRecordsStatus
13 Aug 2025Change Healthcare Radiology Solutions software version 14.2.2DeviceClass II1Ongoing
22 May 2025Change Healthcare Cardiology Hemo SoftwareDeviceClass II2Ongoing
21 Aug 2024Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.DeviceClass II3Ongoing
1 Nov 2023Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.DeviceClass II1Ongoing
12 Oct 2023Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.DeviceClass II1Ongoing
19 Apr 2021Change 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.DeviceClass II1Ongoing
17 Mar 2021Change Healthcare Enterprise ViewerDeviceClass II1Ongoing
25 Aug 2020Change Healthcare Radiology Solutions 14.0DeviceClass II1Terminated
10 Feb 2020McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG ManagementDeviceClass II1Ongoing

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

CHANGE HEALTHCARE CANADA COMPANY: events for each product type
TypeEvents
Device9
CHANGE HEALTHCARE CANADA COMPANY: events in each class
ClassEvents
Class II9
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
8

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of CHANGE HEALTHCARE CANADA COMPANY, by the year that the recall started. The largest year is 2020, with 2 events.

Official channels

Cite this page

Recall Register. CHANGE HEALTHCARE CANADA COMPANY: FDA recalls. https://recallregister.com/firm/change-healthcare-canada-company/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A, British Columbia

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of CHANGE HEALTHCARE CANADA COMPANY have?
Class II: 9 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of CHANGE HEALTHCARE CANADA COMPANY?
FDA event 97545, which the firm started on 13 Aug 2025. The first product in the record is: Change Healthcare Radiology Solutions software version 14.2.2
How many FDA recalls of CHANGE HEALTHCARE CANADA COMPANY have the status Ongoing?
8 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.