FDAClass IIAugust 5, 2026

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT recall

Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

Why was Brilliance iCT Brilliance iCT Upgrades Brilliance iCT recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232

Product
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
128
Distribution
US Nationwide Distribution including Puerto Rico
Recall date
August 5, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls