Recall Z-0237-2024 ยท LLZ System, Image Processing, Radiological
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
| Date | Nov 6, 2023 (initiated Oct 12, 2023) |
| Status | Open, Classified |
| Reason | Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications. |
| Root cause | Software design |
| Action | Field Safety Notice was distributed to all consignees on10/12/2023 by email. The notice explained the issue, potential risk to the patient, and directed users to to check the CHRS Exception Tracker on a regular basis, as failed updates will be listed with details on the failure. Recommended actions to take on potentially affected data: Impacted data can be identified by using the CHRS Exception Tracker. Customers are advised to review records of recent updates from CHRS to external systems and manually update any changes to study records that may have been missed. Change Healthcare will i |
| Quantity | 282 units |
| Distribution | US, Canada, Ireland, Saudi Arabia, France, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140909 | MCKESSON RADIOLOGY Mckesson Medical Imaging Company, Jul 2, 2014 |