Agfa HealthCare Enterprise Imaging XERO Viewer — Class II medical device recall Z-1004-2023
Ongoing recall by Agfa Healthcare NV, reported 2023-02-01. There is a software defect that can cause issues with images.
| Recall number | Z-1004-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa Healthcare NV, Mortsel, N/A, Belgium |
| Recall initiated | 2022-12-05 |
| Classified | 2023-01-20 |
| Reported by FDA | 2023-02-01 |
| Countries outside the US | AU, BE, BR, CA, CL, CY, ES, FR, GB, IE, IS, IT, KE, LU, NL, RO, SA, SE, ZA |
| Quantity | 110 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05400874000710 |
Product
Agfa HealthCare Enterprise Imaging XERO Viewer
Reason for recall
There is a software defect that can cause issues with images.
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-1004-2023. 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.