Change Healthcare Radiology Solutions software version 14.2.2
FDA Recall Z-0030-2026 · Posted 2025-10-02
Recalling FirmCHANGE HEALTHCARE CANADA COMPANY
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2025-08-13
Product Quantity12 programs
Reason for Recall
Due to software issue, radiology reports may not be fully displayed when viewing.
Firm 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.
Root Cause
Software Design Change
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AR, WI, NJ, IN, AL, CA, WA, FL, MA, LA and the country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.