Recall Z-2206-2026 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
| Date | Jun 4, 2026 (initiated Mar 9, 2026) |
| Status | Open, Classified |
| Reason | During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026. |
| Distribution | US and Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241572 | ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) Siemens Medical Solutions USA, Inc., Oct 22, 2024 |