Enterprise Imaging XERO Viewer- software application used for… — Class II medical device recall Z-0055-2025
Ongoing recall by Agfa Healthcare NV, reported 2024-10-16, distributed nationwide. Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly place
| Recall number | Z-0055-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Agfa Healthcare NV, Mortsel, Belgium |
| Recall initiated | 2024-09-06 |
| Classified | 2024-10-10 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, CA, CL, CO, CY, CZ, DK, DO, EC, EE, EG, ES, GB, GR, HK, HR, IE, IS, IT, JO, KE, KW, LB, LU, MX, NI, NL, NO, OM, PE, PK, PL, RO, SA, SE, SG, SI, TN, ZA |
| Quantity | 801 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05400874000710 |
Product
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000 (including all SU s and HF s)
Reason for recall
Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.
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-0055-2025. 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.