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Class IIOngoing

Philips North America Llc recalls 4 products

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as fda mandated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Philips North America Llc
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US and US Territories.
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99784…

Products (4)

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

    Codes/lots: UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.Quantity: N/ARecall no. Z-3040-2026Class II

  2. Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x

    Codes/lots: UDI:N/AQuantity: N/ARecall no. Z-3041-2026Class II

  3. Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x

    Codes/lots: UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/AQuantity: N/ARecall no. Z-3042-2026Class II

  4. Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x

    Codes/lots: Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.Quantity: N/ARecall no. Z-3043-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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