Class 2 Device Recall ARTIS pheno

• Date Initiated by Firm: March 09, 2026
• Date Posted: June 04, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2206-2026
• Recall Event ID: 98992
• 510(K)Number: K241572
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• 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
• Code Information: ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: 610-219-4834
• Manufacturer 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: Distribution of Customer Advisory Notice (CAN) to all affected customers began by Siemens on March 9, 2026.
• Distribution: US and Worldwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB