Change Healthcare Radiology Solutions 14 — Class II medical device recall Z-0072-2021
Terminated recall by CHANGE HEALTHCARE CANADA COMPANY, reported 2020-10-14, distributed in MS, NE, VT, WV. Software defect which may potentially result in one or more images missing in a study
| Recall number | Z-0072-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CHANGE HEALTHCARE CANADA COMPANY, Richmond, N/A, Canada |
| Recall initiated | 2020-08-25 |
| Classified | 2020-10-08 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2021-02-16 |
| Distributed | MS, NE, VT, WV |
| Quantity | 5 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 17540262030020 |
| Model numbers | 14.0 |
Product
Change Healthcare Radiology Solutions 14.0
Reason for recall
Software defect which may potentially result in one or more images missing in a study
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-0072-2021. 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.