Recall Z-2205-2026
Siemens Medical Solutions USA, Inc · initiated March 9, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Codes / lots: UDI: 4056869046877
Reason for recall
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.
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026.
Details
- Recall number
- Z-2205-2026
- Initiated
- March 9, 2026
- Posted by FDA
- June 4, 2026
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Distribution
- US and Worldwide
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2206-2026 Class II | ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono…During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient.… | 03/09/2026Open, Classified |