Siemens Medical Solutions USA, Inc Recall 89260
Description: Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700
Siemens Medical Solutions USA, Inc Recall 89260 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0517-2022 |
| Event ID | 89260 |
| Event Description | Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 23 units |
| Recall 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 |
| Device Classification | 20220202 |
| Device Code Info | 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 |
| Center Classification Date | 20220121 |
| Recall Initiation Date | 20211012 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
| Similar To |