CLASS II ONGOING Device recall · Reported 9 Sep 2026 · FDA Enforcement Report

Philips Brilliance recalled by Philips North America

Philips North America is recalling Philips Brilliance. The recall was initiated on 7 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3040-2026
FDA event ID: 99784
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 7 Aug 2026
FDA classified: 1 Sep 2026
Reported: 9 Sep 2026
Type: FDA Mandated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Medical Software

Timeline

7 Aug 2026	Recall initiated by company
1 Sep 2026	Classified by FDA	+25 days
9 Sep 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.

Where it was distributed

US and US Territories.

Questions about this recall

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.

Which lots are affected?

UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.

Where was it sold?

US and US Territories.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

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

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99784

This product is part of a recall event; the main page for the event is Philips Brilliance CT 64: Brilliance CT 64 Channel recalled.

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
9 Sep 2026	CLASS II	Philips Ingenuity CT recalled by Philips North America	Philips North America	Device Malfunction	MA
9 Sep 2026	CLASS II	Philips IQon Spectral CT recalled by Philips North America	Philips North America	Device Malfunction	MA

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All 545

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