Z-0030-2026Class II

Change Healthcare Radiology Solutions software version 14.2.2

Name: Z-0030-2026 Change Healthcare Radiology Solutions software version 14.2.2
Creator: Change Healthcare Canada Company
Published: 2025-08-13
License: https://open.fda.gov/license/

Change Healthcare Canada Company / initiated 2025-08-13 / Open, Classified / root cause: software

FDA source

CHANGE HEALTHCARE CANADA COMPANY began a recall of Change Healthcare Radiology Solutions software version 14.2.2 on 2025-08-13. FDA classified it as Class II and gives the reason as "Due to software issue, radiology reports may not be fully displayed when viewing". 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-0030-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-13
Posted: 2025-10-02
Recalling firm: Change Healthcare Canada Company
Product: Change Healthcare Radiology Solutions software version 14.2.2
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Due to software issue, radiology reports may not be fully displayed when viewing.
Root cause tag: software
FDA root cause: Software Design Change
Action: On August 13, 2025, Change Healthcare Canada Company issued a Urgent Medical Device Recall notification to affected consignees via Email. Chang Healthcare asked consignees to take the following actions: 1. Generate an audit report to list all studies accessed since CHRS 14.2.2 client was first installed. 2. Re-evaluate the identified cases and take any necessary follow-up measures to confirm that each patient s diagnosis and management remain appropriate. 4. This notice must be distributed to all personnel within your organization who need to be aware 5. To ensure effectiveness of any required corrective actions, please maintain awareness of this RECALL until the issue has been fully resolved. 6. Please notify our Customer Support department at: 1-800-663-2533 that you have read and understood the recall notice and schedule your product update to be installed on your system.
Quantity in commerce: 12 programs
Distribution: Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Product codes and lots: Version 14.2.2/UDI: (01)17540262030068

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0030-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0030-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-08	2025-10-02

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)