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PHILIPS MEDICAL SYSTEMS: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades

Medical DevicesSource: FDA (device) · Date: 2026-08-05

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
PHILIPS MEDICAL SYSTEMS
Product
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide Distribution including Puerto Rico
Recall initiated
2026-06-11
Code info
FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232
Product quantity
128
Voluntary mandated
FDA Mandated
City
Cambridge
State
MA
Country
United States
Event id
99352
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