Richmond, Canada
CHANGE HEALTHCARE CANADA COMPANY recalls
9 recalls recorded since 2018, most recently on 13 August 2025. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)8
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 August 2025
- Reason
- Due to software issue, radiology reports may not be fully displayed when viewing.
- Distribution
- Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0030-2026
- Change Healthcare Radiology Solutions software version 14.2.2
Ongoing Class II Medical devices
- Recall started
- 22 May 2025
- Reason
- Due to complaints, software update may cause software to unexpectedly shutdown.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, KY MO, MS, NE, NH, NJ, PA, TN, TX, WA and the countries of Australia, Canada, Germany, Great Britain, Ireland, Israel, New Zealand.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2072-2025, Z-2071-2025
- Change Healthcare Cardiology Hemodynamics Software
- Change Healthcare Cardiology Hemo Software
Ongoing Class II Medical devices
- Recall started
- 21 August 2024
- Reason
- A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. This issue occurs when the unit of measurement (UOM) for hemoglobin is configured in a way that differs from the users understanding.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Ireland, Israel, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0127-2025, Z-0126-2025, Z-0128-2025
- Horizon Cardiology Hemo. Version 12.2.
- Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
- McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Ongoing Class II Medical devices
- Recall started
- 1 November 2023
- Reason
- Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
- Distribution
- US Nationwide distribution. There was no military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0551-2024
- Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Ongoing Class II Medical devices
- Recall started
- 12 October 2023
- Reason
- Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.
- Distribution
- US, Canada, Ireland, Saudi Arabia, France, UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0237-2024
- Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Ongoing Class II Medical devices
- Recall started
- 19 April 2021
- Reason
- A software defect was identified where the Image Styles defined by presentation states from CHRS are not displayed in CHEV.
- Distribution
- US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IA, IN, IL, KY, NE, NY, MA, MI, MS, OH, PA, TX,TN, WA, WI, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Ongoing Class II Medical devices
- Recall started
- 17 March 2021
- Reason
- Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
- Distribution
- Domestic Distribution only. IN, KY, CA, NY, WA, IL, IA, FL, TX, WA, MI, HI, AK, WI, WY, NE, AZ, OH, PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1508-2021
- Change Healthcare Enterprise Viewer
Terminated Class II Medical devices
- Recall started
- 25 August 2020
- Terminated
- 16 February 2021
- Reason
- Software defect which may potentially result in one or more images missing in a study
- Distribution
- Domestic distribution to VT, MS, WV, NE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0072-2021
- Change Healthcare Radiology Solutions 14.0
Ongoing Class II Medical devices
- Recall started
- 10 February 2020
- Reason
- Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format
- Distribution
- Distribution US nationwide, Canada and the United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1682-2020
- McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.