Artis Pheno — Class II medical device recall Z-2529-2025
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2025-09-17, distributed nationwide. Limited system movements after startup .
| Recall number | Z-2529-2025 |
|---|---|
| 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 | 2025-08-12 |
| Classified | 2025-09-05 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 04056869046877 |
| Serial numbers | 164011, 164019, 164026, 164027, 164069, 164071, 164072, 164080, 164084, 164086, 164094, 164097, 164100, 164105, 164152, 164158, 164161, 164183, 164184, 164188 |
| Model numbers | 10849000 |
Product
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Reason for recall
Limited system movements after startup .
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-2529-2025. 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.