FDA Recall
Open, Classified
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
Recall: Z-2206-2026
·
Initiated March 9, 2026
Recall
- Recall Number
- Z-2206-2026
- Event Number
- 98992
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Open, Classified
- Root Cause
- Radiation Control for Health and Safety Act
- Initiated
- March 9, 2026
- Posted
- June 4, 2026
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
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
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.
Action
Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026.
Distribution
US and Worldwide