FDA · Class II · September 9, 2026

Philips recall: Brilliance and 3 more products

Philips North America Llc is recalling Philips Brilliance and 3 more products – N/A. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 7, 2026. Distributed US and US Territories..

Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	Philips Brilliance and 3 more products
Brand	Philips
Company	Philips North America Llc
Type	Medical devices
Classification	Class II
Recall date	August 7, 2026
Published by FDA	September 9, 2026
Quantity	N/A
Recall ID	99784

As listed by FDA

Recalled products (4)

Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
FDA recall number
Z-3040-2026
Codes, lots and dates
UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.
Quantity
N/A
Classification
Class II
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
FDA recall number
Z-3041-2026
Codes, lots and dates
UDI:N/A
Quantity
N/A
Classification
Class II
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
FDA recall number
Z-3042-2026
Codes, lots and dates
UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A
Quantity
N/A
Classification
Class II
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
FDA recall number
Z-3043-2026
Codes, lots and dates
Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.
Quantity
N/A
Classification
Class II

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99784
Initiated: FDA Mandated
Status: Ongoing
Firm location: Cambridge, MA, United States

Why it was recalled

The reason the FDA lists: “Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.”

Where it was sold

Distribution as the FDA records it: “US and US Territories.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99784, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other Philips recalls

Date	Recall	Problem	Agency
Oct 7, 2026	Philips recall: Medical Systems Technologies LtdMedical devices · 62	an increased risk of a crash Serious	FDA Class II
Oct 7, 2026	Philips recall: Ingenia Blue Seal SE and Blue Seal XE and 11 more productsMedical devices · 6; 216; 243; 422; 340; 131; 107; 200; 5; 1; 30; 91	When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR… Serious	FDA Class II
Sep 30, 2026	Philips recall: Achieva 1.5T and 11 more productsMedical devices · 387; 210; 15; 91; 2038; 922; 1447; 596; 82; 611; 37; 965	A software issue will terminate an examination during the image reconstruction process if … Serious	FDA Class II
Sep 23, 2026	Philips recall: Patient Information Center iX REF:866389 and 1 more productMedical devices · 7359 Units; 312 units	Due to software malfunction, patient information system may freeze and become unresponsive… Serious	FDA Class II
Aug 26, 2026	Philips recall: Cardiac Workstation 5000 and 1 more productMedical devices · 796 units; 1,810 units	Device will intermittently provide inaccurate data related to native heart rate. Serious	FDA Class II

All 6 Philips recalls →

FAQ

About this recall

Is Philips Philips Brilliance recalled?

Yes. Philips North America Llc recalled it on August 7, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

What should I do if I have it?

Where was it sold?

US and US Territories..

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.