ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model:… — Class II medical device recall Z-1144-2021
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2021-03-03, distributed nationwide. Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono fl
| Recall number | Z-1144-2021 |
|---|---|
| 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 | 2020-12-18 |
| Classified | 2021-02-23 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2021-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 41 u.s |
| Reason classes | software |
| Serial numbers | 170023, 170025, 170026, 170027, 170051, 170053, 180014, 180015, 180018, 180019, 180029, 180034, 180035, 180037, 180040, 180041, 180043, 180046, 180047, 180048, 180049, 180053, 180054, 180055, 180056 and 16 more |
| Model numbers | 11327600, 11327700 |
Product
ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 with software version VE20B - Product Usage: Intended for single and biplane diagnostic imaging and interventional procedures.
Reason for recall
Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or ARTIS Icono floor systems with software version VE20B. Potential issues include System error management, Erroneous error messages, Zoom/Pan Function, Grid Indication, and Coolant Level. May cause procedures 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-1144-2021. 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.