syngo Application software VE20 — Class II medical device recall Z-1339-2022
Ongoing recall by Siemens Medical Solutions USA, Inc, reported 2022-07-13, distributed nationwide. After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image
| Recall number | Z-1339-2022 |
|---|---|
| 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 | 2022-02-25 |
| Classified | 2022-07-06 |
| Reported by FDA | 2022-07-13 |
| Distributed | Nationwide (US) |
| Quantity | 127 units |
| UPC / GTIN / UDI-DI | 04056869046877, 04056869063317, 04056869149325 |
| Serial numbers | 164311, 164321, 164703, 164711, 164712, 164718, 164719, 164721, 164722, 164723, 164724, 164725, 164726, 164728, 164735, 164739, 164740, 164741, 164743, 164760, 164763, 170025, 170026, 170053, 170303 and 102 more |
| Model numbers | 10849000, 11327600, 11327700 |
Product
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
Reason for recall
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
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-1339-2022. 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.