ARTIS Pheno VE30A and VE40A, Model 10849000
FDA Device Recall #Z-1814-2026 - Class II, March 12, 2026
Recall Summary
| Recall Number | Z-1814-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | March 12, 2026 |
| Status | Ongoing |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 73 |
Product Description
ARTIS Pheno VE30A and VE40A, Model 10849000
Reason for Recall
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Distribution Pattern
U.S. and O.U.S.
Lot / Code Information
UDI 04056869046877
Other Recalls from Siemens Medical Solutions USA, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2648-2026 | Class II | ARTIS icono ceiling. Model Number: 11328100. | Jun 8, 2026 |
| Z-2642-2026 | Class II | ARTIS icono ceiling. Model Number: 11328100. | May 20, 2026 |
| Z-2641-2026 | Class II | ARTIS icono biplane. Model Number: 11327600. | May 20, 2026 |
| Z-2643-2026 | Class II | ARTIS icono floor. Model Number: 11327700. | May 20, 2026 |
| Z-1653-2026 | Class II | ARTIS pheno and ARTIS Icono biplane, floor and ... | Mar 10, 2026 |
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.