Official recall notice
FDA Recall: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brill
- Recall date
- 2026-08-05
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232