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MEDICAL DEVICE RECALLMODERATE
Philips Brilliance CT Systems
Philips recalls Brilliance iCT and related CT systems over unintended radiation issue.
What to do
Contact Philips North America LLC for further instructions and to schedule the necessary software update or service.
Why it was recalled
Philips North America LLC is recalling certain Philips Brilliance CT systems, including Brilliance iCT, Brilliance iCT Upgrades, and Brilliance iCT SP, due to an unintended radiation issue that could affect equipment performance.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UDI-DI |
|---|---|
| Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311. | 00884838059474 |
| Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x | 00884838083325 |
| Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x | – |
| Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x | 00884838098701, 00884838059863, 128 |
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
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Editorial summary by Recall Canary · summary updated 2026-09-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification