United StatesPhilips is recalling specified CT systems: Brilliance iCT (and upgrades), IQon Spectral CT (and upgrades), and various Ingenuity CT models and upgrades, identified by the listed FCO and DI numbers and sold U.S. nationwide including Puerto Rico. The clinical scan may not automatically trigger after the Bolus Tracking scan or may produce additional Bolus Tracking shots, which can make the clinical acquisition inadequate for diagnosis and could require patient rescan and additional radiation exposure.
What's being recalled
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
IQon Spectral CT IQon Spectral CT Upgrades
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Recalling firm: Philips Medical Systems, Cambridge, MA, United States.
How to identify it
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232 FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542 FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide Distribution including Puerto Rico
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)