Artis pheno- Model No — Class II medical device recall Z-1646-2022
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-1646-2022 |
|---|---|
| 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 | 04056869046877 |
| Serial numbers | 164022, 164034, 164048, 164060, 164069, 164071, 164072, 164074, 164084, 164086, 164095, 164097, 164098, 164100, 164105, 164113, 164138, 164140, 164153, 164163, 164172, 164183, 164184, 164186, 164187 and 49 more |
| Model numbers | 10849000 |
Product
Artis pheno- Model No. 10849000
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-1646-2022. 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.