CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Brand
CHANGE HEALTHCARE CANADA COMPANY
Lot Codes / Batch Numbers
UDI/DI 17540262030020
Products Sold
UDI/DI 17540262030020
CHANGE HEALTHCARE CANADA COMPANY is recalling Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and info due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Field Safety Notice was distributed to all consignees on10/12/2023 by email. The notice explained the issue, potential risk to the patient, and directed users to to check the CHRS Exception Tracker on a regular basis, as failed updates will be listed with details on the failure. Recommended actions to take on potentially affected data: Impacted data can be identified by using the CHRS Exception Tracker. Customers are advised to review records of recent updates from CHRS to external systems and manually update any changes to study records that may have been missed. Change Healthcare will install a software update.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026