ARTIS pheno-Angiography systems developed for single and biplane… — Class II medical device recall Z-2361-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-08-16, distributed nationwide. Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable conne
| Recall number | Z-2361-2023 |
|---|---|
| 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 | 2023-06-19 |
| Classified | 2023-08-08 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CL, CN, CZ, DE, DK, DZ, ES, FI, FR, GB, HK, ID, IN, IT, JP, LU, LV, MX, NL, NO, NZ, PL, QA, RO, SE, SI, SK, TH, TR, TW, ZA |
| Quantity | 10 units |
| UPC / GTIN / UDI-DI | 04056869149325 |
| Serial numbers | 164833, 164836, 164840, 164845, 164850, 164851, 164853, 164854, 164855, 164856 |
Product
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
Reason for recall
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
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-2361-2023. 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.