Class 2 Device Recall ARTIS icono biplane

• Date Initiated by Firm: September 24, 2026
• Date Posted: November 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0370-2027
• Recall Event ID: 100014
• 510(K)Number: K254173
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: ARTIS icono ceiling. Model Number: 11328100.
• Code Information: Model Number: 11328100. UDI-DI: 4056869295923. Serial Number: 190047. Software Version VE50B.
• FEI Number: 2240869
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 40 Liberty Blvd; Malvern PA 19355-1418
• For Additional Information Contact: Anastasia Sokolova; 610-219-4834
• Manufacturer Reason for Recall: Potential that the system may not execute movement control commands as intended and may display the following message to the user, "Limited stand/table movement, SC."
• FDA Determined Cause: Under Investigation by firm
• Action: Siemens notified consignees on about 09/24/2026 via letter titled "CUSTOMER SAFETY ADVISORY NOTICE." Consignees were instructed that before initiating a procedure, particularly any time-critical or high-risk treatment step, the healthcare professional must assess whether the planned procedure can be safely performed using the affected system. If the described behavior occurs, discontinue attempts to perform the affected motorized movement. Due to the intermittent nature of the issue, a system restart is expected to restore motorized movement in most cases. Restoration cannot be guaranteed. If the issue occurs while an interventional device is in the patient, imaging and visualization functions remain available. Based on the clinical situation and the assessment, the current procedural step may be completed only if it can be performed safely without the affected motorized movement. Subsequently, retrieve the interventional devices in a controlled manner under continuous imaging guidance. If the described behavior occurs during a procedure and immediate access to the patient is required, follow the patient rescue and emergency procedures specified in the Operator Manual. Consignees were also instructed to ensure all users of the affected system are informed of these instructions and are familiar with the applicable patient rescue and emergency procedures in the Operator Manual. Also confirm acknowledgment of the notification letter. The manufacturer is conducting investigation of the reported system behavior and will provide additional instructions if needed. On about 10/16/2026 an additional communication was sent to consignees notifying them that Siemens is implementing a Field Safety Corrective Action for affected systems, which includes a software-supported recovery function via Patch 3.5. The corrective action is being distributed through Update Instruction AX053/26/S.
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the states of CA, KY, NY, TX.
• 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