{"recall":{"id":"fda-device-99784","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Philips North America Llc recalls 4 products","firm":"Philips North America Llc","date":"2026-08-07","reported":"2026-09-09","status":"Ongoing","classification":"Class II","products":[{"name":"Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.","code":"UDI for Brilliance iCT: (01)00884838059474, UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.","quantity":"N/A","number":"Z-3040-2026","classification":"Class II"},{"name":"Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x","code":"UDI:N/A","quantity":"N/A","number":"Z-3041-2026","classification":"Class II"},{"name":"Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x","code":"UDI: Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A","quantity":"N/A","number":"Z-3042-2026","classification":"Class II"},{"name":"Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x","code":"Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.","quantity":"N/A","number":"Z-3043-2026","classification":"Class II"}],"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).","affected":"US and US Territories.","nationwide":false,"states":[],"units":"N/A; N/A; N/A; N/A","remedy":"","whatToDo":"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.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99784","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7ea322eaed3d7ca9","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99784","record":[{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99784","recalling_firm":"Philips North America Llc","address_1":"222 Jacobs St","address_2":"N/A","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"N/A","distribution_pattern":"US and US Territories.","recall_number":"Z-3040-2026","product_description":"Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x     Product Codes: 728306, 728305, 728311.","product_quantity":"N/A","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.","recall_initiation_date":"20260807","center_classification_date":"20260901","report_date":"20260909","code_info":"UDI for Brilliance iCT: (01)00884838059474,  UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99784","recalling_firm":"Philips North America Llc","address_1":"222 Jacobs St","address_2":"N/A","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"N/A","distribution_pattern":"US and US Territories.","recall_number":"Z-3041-2026","product_description":"Philips IQon Spectral CT     Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331  Software 4.7.7.x","product_quantity":"N/A","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.","recall_initiation_date":"20260807","center_classification_date":"20260901","report_date":"20260909","code_info":"UDI:N/A","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99784","recalling_firm":"Philips North America Llc","address_1":"222 Jacobs St","address_2":"N/A","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"N/A","distribution_pattern":"US and US Territories.","recall_number":"Z-3042-2026","product_description":"Philips Ingenuity CT  Product Codes: Ingenuity CT Upgrades 728327,   Ingenuity CT China 728324,  Ingenuity Core 128 Elite Brazil 728325.   Software 4.4.10.x","product_quantity":"N/A","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.","recall_initiation_date":"20260807","center_classification_date":"20260901","report_date":"20260909","code_info":"UDI:  Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A","more_code_info":""},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99784","recalling_firm":"Philips North America Llc","address_1":"222 Jacobs St","address_2":"N/A","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"N/A","distribution_pattern":"US and US Territories.","recall_number":"Z-3043-2026","product_description":"Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x","product_quantity":"N/A","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.","recall_initiation_date":"20260807","center_classification_date":"20260901","report_date":"20260909","code_info":"Brilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.","more_code_info":""}]}}