ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling ...

FDA Device Recall #Z-2206-2026 — Class II — March 9, 2026

Recall Summary

Recall Number Z-2206-2026
Classification Class II — Moderate risk
Date Initiated March 9, 2026
Status Ongoing
Voluntary FDA Mandated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices

Product 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 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.

Distribution Pattern

US and Worldwide

Lot / Code Information

ARTIS icono biplane UDI 4056869063317 ARTIS icono ceiling UDI 4056869295923 ARTIS icono floor UDI 4056869149325

Other Recalls from Siemens Medical Solutions USA, Inc

Recall # Classification Product Date
Z-1814-2026 Class II ARTIS Pheno VE30A and VE40A, Model 10849000 Mar 12, 2026
Z-1653-2026 Class II ARTIS pheno and ARTIS Icono biplane, floor and ... Mar 10, 2026
Z-2205-2026 Class II ARTIS pheno, Model 10849000. interventional flu... Mar 9, 2026
Z-1175-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025
Z-1174-2026 Class II Interventional Fluoroscopic X-Ray System: LUMIN... Dec 29, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.