ARTIS pheno — Class II medical device recall Z-0119-2023
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-11-02, distributed nationwide. Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE1
| Recall number | Z-0119-2023 |
|---|---|
| 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 | 2022-09-20 |
| Classified | 2022-10-21 |
| Reported by FDA | 2022-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 140 us |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869046877 |
| Serial numbers | 164011, 164013, 164018, 164019, 164021, 164022, 164024, 164025, 164026, 164027, 164033, 164034, 164048, 164049, 164053, 164054, 164055, 164057, 164060, 164061, 164063, 164064, 164066, 164068, 164069 and 115 more |
| Model numbers | 10849000 |
Product
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Reason for recall
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate 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-0119-2023. 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.