Official recall record

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

US FDA — Medical Devices · 2026-06-11 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Alert date: 2026-06-11
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838059474
Brand on record: PHILIPS MEDICAL SYSTEMS

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2017-11-10 · US FDA — Medical Devices
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray
2026-01-07 · US FDA — Medical Devices
Brilliance iCT; Product Code (REF): 728306;
2020-04-06 · US FDA — Medical Devices
Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)008848
2021-06-08 · US FDA — Medical Devices
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
2025-08-13 · US FDA — Medical Devices
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

Other recalls from this brand

2026-06-11 · US FDA — Medical Devices
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades In
2026-03-07 · US FDA — Medical Devices
Philips Spectral CT on Rails. Model Number: 728334.

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.