Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Br...
FDA Device Recall #Z-2650-2026 - Class II, June 11, 2026
Recall Summary
| Recall Number | Z-2650-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | June 11, 2026 |
| Status | Ongoing |
| Voluntary | FDA Mandated |
Recalling Firm
| Firm | PHILIPS MEDICAL SYSTEMS |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 128 |
Product Description
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Reason for Recall
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Distribution Pattern
US Nationwide Distribution including Puerto Rico
Lot / Code Information
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
Other Recalls from PHILIPS MEDICAL SYSTEMS
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2652-2026 | Class II | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ing... | Jun 11, 2026 |
| Z-2651-2026 | Class II | IQon Spectral CT IQon Spectral CT Upgrades | Jun 11, 2026 |
| Z-1825-2026 | Class II | Philips Spectral CT on Rails. Model Number: 728... | Mar 7, 2026 |
| Z-0376-2026 | Class II | Model: CT 5300; Product Code (REF): 728285; S... | Sep 25, 2025 |
| Z-0377-2026 | Class II | Model: Incisive CT for Brazil SKD; Product Cod... | Sep 25, 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.