Change Healthcare Radiology Solutions software version 14.2.2
FDA device recall Z-0030-2026 · posted 2025-10-02 · Open, Classified
Recall details
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Reason for recall
- Due to software issue, radiology reports may not be fully displayed when viewing.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 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.
- Date initiated
- 2025-08-13
- Date posted
- 2025-10-02
- Location
- Richmond, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCKESSON RADIOLOGY (K140909) | Mckesson Medical Imaging Company | 2014-07-02 |