Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and...
FDA Device Recall #Z-1167-2023 - Class II, December 21, 2022
Recall Summary
| Recall Number | Z-1167-2023 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 21, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Siemens Medical Solutions USA, Inc |
| Location | Malvern, PA |
| Product Type | Devices |
| Quantity | 2 units; Expanded recall: 53 units |
Product Description
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Reason for Recall
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
UDI: 4056869009162 S/N: 5037 5951 Expanded Recall 2/24/23: 5069 5085 5209 5234 5340 5364 5634 5664 5682 5919 5920 5921 5947 5953 5954 5956 5963 7075 7098 7147 7162 7168 7172 7208 7266 7310 7319 7391 7404 7442 7460 7488 7545 7743 7771 8074 8093 8094 8183 8198 8223 8242 8244 8275 8320 8322 8334 8361 8371 8378 8385 8389
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-1814-2026 | Class II | ARTIS Pheno VE30A and VE40A, Model 10849000 | Mar 12, 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.