Interventional Fluoroscopic X-Ray System ARTIS icono biplane-… — Class II medical device recall Z-1497-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-05-05, distributed nationwide. Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be t
| Recall number | Z-1497-2021 |
|---|---|
| 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 | 2021-03-19 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2021-11-09 |
| Distributed | Nationwide (US) |
| Quantity | 133 systems |
| Reason classes | software |
| Serial numbers | 164703, 170025, 170303, 170304, 170305, 170307, 170309, 170310, 170312, 170319, 180014, 180015, 180037, 180040, 180047, 180048, 180060, 180062, 180072, 180080, 180083, 180085, 180301, 180305, 180309 and 10 more |
Product
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason for recall
Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray 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-1497-2021. 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.