Recall Z-2206-2026
- Recall number
- Z-2206-2026
- Event number
- 98992
- Firm
- Siemens Medical Solutions USA, Inc
- Firm FEI
- 2240869
- Product code
- OWB
- Status
- Open, Classified
- Initiated
- 2026-03-09
- Posted
- 2026-06-04
- Root cause
- Radiation Control for Health and Safety Act
- 510(k) numbers
- K241572, K170800, K243646, K181966, K223409, K151000, K082243, K161976, K240224, K172180, K203281, K221344, K232344, K121772, K210055, K141574, K250241, K974355, K912448, K122457, K022322, K252500, K151598, K061203, K222625, K021049, K183109, K103425, K240199, K123529
Product#
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 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.