Artis icono biplane- Model No — Class II medical device recall Z-1647-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-09-07, distributed nationwide. Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono
| Recall number | Z-1647-2022 |
|---|---|
| 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 | 2022-08-10 |
| Classified | 2022-08-26 |
| Reported by FDA | 2022-09-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CN, CO, CR, CZ, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, ID, IE, IL, IN, IR, IT, JO, JP, KR, KW, LB, LU, MX, MY, NL, NO, NZ, OM, PH, PL, PT, QA, RS, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, VN, ZA |
| UPC / GTIN / UDI-DI | 04056869063317, 04056869149325 |
| Serial numbers | 170025, 170026, 170051, 170053, 170319, 170322, 170343, 170346, 170349, 170357, 170358, 170360, 170361, 170364, 170365, 170367, 170368, 170378, 170383, 170384, 170385, 170386, 170387, 170388, 170389 and 98 more |
| Model numbers | 11327600, 11327700 |
Product
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
Reason for recall
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
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-1647-2022. 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.