System Material # Artis zee floor 10094135 Artis zee ceiling 10094137… — Class II medical device recall Z-1040-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2023-02-08, distributed nationwide. In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating
| Recall number | Z-1040-2023 |
|---|---|
| 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 | 2022-12-16 |
| Classified | 2023-01-30 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 04056869009971, 04056869009988, 04056869009995, 04056869010007, 04056869010014, 04056869010021, 04056869010038, 04056869010045, 04056869010052, 04056869010069, 04056869010076, 04056869010083 |
| Serial numbers | 103008, 103030, 103048, 103218, 103222, 103230, 103245, 103258, 103348, 103384, 104005, 104007, 104012, 104013, 104016, 104020, 104025, 104027, 104029, 104047, 104049, 104051, 104061, 104062, 105007 and 475 more |
Product
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
Reason for recall
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may 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-1040-2023. 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.