CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions software version 14.2.2

Due to software issue, radiology reports may not be fully displayed when viewing.

Change Healthcare Radiology Solutions software version 14.2.2

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.

• FDA enforcement recordOfficial FDA database entry for Z-0030-2026
• FDA 510(k) clearance · K140909The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CHANGE HEALTHCARE CANADA COMPANYSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.