FDA Device recall Z-0517-2022
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
- FDA Device
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700 by Siemens Medical Solutions Usa, citing 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 pos….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0517-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-12 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Reason
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
Identifiers
| code_info | Serial Numbers: 170319 170026 170343 170305 170307 170331 170309 170310 170023 170304 170328 170334 170336 170025 17034…Serial Numbers: 170319 170026 170343 170305 170307 170331 170309 170310 170023 170304 170328 170334 170336 170025 170346 170051 170333 170332 170312 170027 170303 170322 170053 UDI: 04056869149325 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0517-2022%22
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