Recall Z-0516-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
| Date | Oct 12, 2021 |
| Status | Terminated |
| 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 |
| Root cause | Software design |
| Action | Siemens issued A Customer Safety Advisory Notice dated 10/12/21 to affected customers via AX047/21/S. Additionally, a software update will be initiated for all affected users via Update Instruction AX046/21/S. Letter states reason for recall, health risk and action to take: To avoid inaccurate measurement values, repeat the distance measurements after changing the Auto TOD Calibration or Distance Calibration of the scene. Additionally, before closing the image after performing the calibration, create a screenshot/secondary capture image for post review. The Operator Manual of the affected s |
| Quantity | 72 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193326 | ARTIS Icono Siemens Medical Solutions USA, Inc., Apr 16, 2020 |