ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron r...

FDA Device Recall #Z-0441-2022 — Class II — December 9, 2021

Recall Summary

Recall Number Z-0441-2022
Classification Class II — Moderate risk
Date Initiated December 9, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Siemens Medical Solutions USA, Inc
Location Malvern, PA
Product Type Devices
Quantity 13 units

Product Description

ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815

Reason for Recall

Potential safety issue under specific preconditons that may result in a user selecting the wrong site for treatment with the possibility to deliver dose to the wrong isocenter which could result in serious patient injury

Distribution Pattern

US Nationwide distribution in the states of IA, LA, NE, NJ, NV, NY, OH, PA, SC, SD.

Lot / Code Information

Serial Numbers: 10085 10524 10737 10736 10586 10792 10793 10822 10843 10850 10886 10865 11122 UDI: 040568691613655911

Other Recalls from Siemens Medical Solutions USA, Inc

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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-2206-2026 Class II ARTIS Icono biplane, floor and ceiling.: ARTIS ... Mar 9, 2026
Z-1175-2026 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.