Food, drugs, devices › Philips North America Llc
Device recall: Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes:
Philips North America Llc (Cambridge, MA) initiated this device recall on 7 Aug 2026; FDA lists 4 product records under event 99784, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: fda mandated. Philips North America Llc has 129 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Philips North America Llc, Cambridge, MA.
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."
Distribution
"US and US Territories."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3040-2026 | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311. | N/A | Class II | Ongoing | 9 Sep 2026 |
| Z-3041-2026 | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x | N/A | Class II | Ongoing | 9 Sep 2026 |
| Z-3042-2026 | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x | N/A | Class II | Ongoing | 9 Sep 2026 |
| Z-3043-2026 | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x | N/A | Class II | Ongoing | 9 Sep 2026 |
Context
Other enforcement events for Philips North America Llc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Jul 2026 | Cardiac Workstation 5000. Product Number: 860439. | Device | Class II | 2 |
| 5 Jun 2026 | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5 | Device | Class II | 1 |
| 26 May 2026 | Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Device | Class II | 2 |
| 1 May 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | Device | Class II | 1 |
| 7 Jan 2026 | Brilliance iCT; Product Code (REF): 728306; | Device | Class II | 4 |
| 12 Dec 2025 | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | Device | Class II | 1 |
| 31 Oct 2025 | IntelliVue MP2. Product Number: M8102A. | Device | Class II | 22 |
| 29 Oct 2025 | Incisive CT; Software Version Number: 4.5, 5.0, 5.1; | Device | Class II | 2 |
| 13 Aug 2025 | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Chan | Device | Class II | 10 |
| 29 May 2025 | Spectral CT. Computed tomography X-ray system. | Device | Class II | 1 |
All 129 events for Philips North America Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US and US Territories."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.