Change Healthcare Radiology Solutions — Class II medical device recall Z-0237-2024
Ongoing recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2023-11-15. Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and
| Recall number | Z-0237-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY, Richmond, Canada |
| Recall initiated | 2023-10-12 |
| Classified | 2023-11-06 |
| Reported by FDA | 2023-11-15 |
| Countries outside the US | CA, FR, GB, IE, SA |
| Quantity | 282 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 17540262030020 |
Product
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0237-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.