Artis pheno with software VE20C- diagnostic imaging angiography… — Class II medical device recall Z-0515-2022
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2022-02-02, distributed nationwide. Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibr
| Recall number | Z-0515-2022 |
|---|---|
| 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 | 2021-10-12 |
| Classified | 2022-01-21 |
| Reported by FDA | 2022-02-02 |
| Terminated | 2024-04-11 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04056869046877 |
| Serial numbers | 164703, 164711, 164712, 164718, 164719, 164721, 164722, 164723, 164724, 164725, 164726, 164728 |
| Model numbers | 10849000 |
Product
Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Reason for recall
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
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-0515-2022. 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.