{"url_path":"/fda/device/recalls/Z-3040-2026","section_key":"summary","section_title":"DEVICE Recall: Philips North America Llc — Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x     Product Codes: 728306, 728305, 728311.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-08-07","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3040-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Philips North America Llc"},"word_count":98,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3040-2026\n\n**Recalling firm:** Philips North America Llc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** FDA Mandated\n**Initiated:** 2026-08-07\n**Report date:** 2026-09-09\n\n## Product\nPhilips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x     Product Codes: 728306, 728305, 728311.\n\n## Reason\nPhilips 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.\n\n## Affected lots\nUDI for Brilliance iCT: (01)00884838059474,  UDI for Brilliance iCT Upgrades: N/A, UDI for Brilliance iCT SP: N/A.\n\n## Distribution\nUS and US Territories."}