{"recall":{"id":"fda-device-99352","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"PHILIPS MEDICAL SYSTEMS recalls 3 products","firm":"PHILIPS MEDICAL SYSTEMS","date":"2026-06-11","reported":"2026-08-05","status":"Ongoing","classification":"Class II","products":[{"name":"Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades","code":"FCO72800812; FCO72800814 728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311 728231 (01)00884838083325 728232","quantity":"128","number":"Z-2650-2026","classification":"Class II"},{"name":"IQon Spectral CT IQon Spectral CT Upgrades","code":"FCO72800812; FCO72800814 728331 728332, DI (01)00884838059542","quantity":"42","number":"Z-2651-2026","classification":"Class II"},{"name":"Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil","code":"FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325","quantity":"182","number":"Z-2652-2026","classification":"Class II"}],"reason":"The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide Distribution including Puerto Rico","nationwide":true,"states":[],"units":"128; 42; 182","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=99352","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"397ee9b128bc82e3","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=99352","record":[{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99352","recalling_firm":"PHILIPS MEDICAL SYSTEMS","address_1":"222 Jacobs St","address_2":"N/A","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide Distribution including Puerto Rico","recall_number":"Z-2650-2026","product_description":"Brilliance iCT   Brilliance iCT Upgrades  Brilliance iCT SP  Brilliance CT 64 Channel  CT6000  Brilliance 64 Upgrades","product_quantity":"128","reason_for_recall":"The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.","recall_initiation_date":"20260611","center_classification_date":"20260727","report_date":"20260805","code_info":"FCO72800812; FCO72800814  728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311  728231 (01)00884838083325  728232"},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99352","recalling_firm":"PHILIPS MEDICAL SYSTEMS","address_1":"222 Jacobs St","address_2":"N/A","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide Distribution including Puerto Rico","recall_number":"Z-2651-2026","product_description":"IQon Spectral CT  IQon Spectral CT Upgrades","product_quantity":"42","reason_for_recall":"The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.","recall_initiation_date":"20260611","center_classification_date":"20260727","report_date":"20260805","code_info":"FCO72800812; FCO72800814  728331 728332, DI (01)00884838059542"},{"status":"Ongoing","city":"Cambridge","state":"MA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99352","recalling_firm":"PHILIPS MEDICAL SYSTEMS","address_1":"222 Jacobs St","address_2":"N/A","postal_code":"02141-2289","voluntary_mandated":"FDA Mandated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide Distribution including Puerto Rico","recall_number":"Z-2652-2026","product_description":"Ingenuity CT  CT5000 Ingenuity Plus  CT5000 Ingenuity Pro  CT5000 Ingenuity Premium  Ingenuity CT Upgrades  Ingenuity CT China  Ingenuity Core 128 Elite Brazil","product_quantity":"182","reason_for_recall":"The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.","recall_initiation_date":"20260611","center_classification_date":"20260727","report_date":"20260805","code_info":"FCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325"}]}}