Recall Z-0030-2026 ยท LLZ System, Image Processing, Radiological
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Radiology Solutions software version 14.2.2
| Date | Oct 2, 2025 (initiated Aug 13, 2025) |
| Status | Open, Classified |
| Reason | Due to software issue, radiology reports may not be fully displayed when viewing. |
| 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 req |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140909 | MCKESSON RADIOLOGY Mckesson Medical Imaging Company, Jul 2, 2014 |