Axiom Artis systems — Class II medical device recall Z-2108-2013
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2013-09-04, distributed in DC, DE, MD, NJ, PA, VA. The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that
| Recall number | Z-2108-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2013-04-26 |
| Classified | 2013-08-28 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2014-11-06 |
| Distributed | DC, DE, MD, NJ, PA, VA |
| Quantity | 178 |
| Model numbers | 10093902, 10093961, 10094135, 10094137, 10094139, 10094141, 10094142, 10094200, 10272410, 10280959, 10281013, 10281163, 475509, 475517, 475525, 5895003, 5904433, 5904441, 7008605, 7151066, 7412807, 755365, 7555357, 7555373, 7728392 and 7 more |
Product
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
Reason for recall
The firm became aware of a potential issue with Axiom Artis systems installed by a third party installer that may involve incorrect channel nuts being used.
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-2108-2013. 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.