FDA recall, , Moderate risk
Philips Brilliance, IQon Spectral and Ingenuity CT Scanners
Philips CT systems have an unintended radiation issue that could affect equipment performance.
Summary by Recall Canary from the FDA notice
What happened
Philips North America Llc, of Cambridge, Massachusetts, began a recall on August 7, 2026, for its Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems due to an unintended radiation issue that could affect equipment performance. The recall was added to the FDA's Enforcement Report and classified on September 1, 2026, and in the FDA's weekly enforcement report on September 9, 2026. The products were distributed in the US and US Territories.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Match the UDI-DI and product code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x
- UDI-DI
- 00884838059474
- Product code
- 728306
- 728305
- 728311.
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
- UDI-DI
- 00884838098701
- 00884838059863
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
- UDI-DI
- 00884838083325
Recall details
- Company began the recall
- Sold in
US and US Territories.
- Company
- Philips North America LlcCambridge, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99784
- Recall numbers
- Z-3040-2026 to Z-3043-2026
All recalls from Philips North America Llc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
