Siemens Medical Solutions USA, Inc Recall 89260
Description: Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Siemens Medical Solutions USA, Inc Recall 89260 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0515-2022 |
| Event ID | 89260 |
| Event Description | Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 12 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: 164719 164712 164722 164723 164728 164711 164718 164703 164721 164726 164724 164725 UDI: 04056869046877 |
| Center Classification Date | 20220121 |
| Recall Initiation Date | 20211012 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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