ARTIS icono — Class II medical device recall Z-0523-2024
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-12-20, distributed nationwide. Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing coll
| Recall number | Z-0523-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2023-10-17 |
| Classified | 2023-12-09 |
| Reported by FDA | 2023-12-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, CN, DE, DK, EG, ES, FI, GB, IL, NL, SE, ZA |
| UPC / GTIN / UDI-DI | 04056869295923 |
| Model numbers | 11328100 |
Product
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
Reason for recall
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
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-0523-2024. 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.