Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic st...
FDA Device Recall #Z-1166-2023 - Class II, December 21, 2022
Recall Summary
| Recall Number | Z-1166-2023 |
| 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 | 1 unit; Expanded Recall: 25 units |
Product Description
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
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: N/A S/N: 4650 Expanded Recall 2/24/23: 4043 4051 4143 4156 4199 4201 4238 4252 4291 4323 4332 4342 4354 4372 4401 4430 4508 4600 4606 4637 4641 4683 4722 4724 4734
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.