Z-0237-2024Class II

Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information...

Name: Z-0237-2024 Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information...
Creator: Change Healthcare Canada Company
Published: 2023-10-12
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2023-10-12 / Open, Classified / root cause: software

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software on 2023-10-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0237-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-12
Posted: 2023-11-06
Recalling firm: Change Healthcare Canada Company
Product: Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 282 units
Distribution: US, Canada, Ireland, Saudi Arabia, France, UK
Product codes and lots: UDI/DI 17540262030020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0237-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0237-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-06

Product code LLZ

K140909Class IIMckesson RadiologyMckesson Medical Imaging Company / cleared 2014-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)