{"url_path":"/fda/device/recalls/Z-3042-2026","section_key":"summary","section_title":"DEVICE Recall: Philips North America Llc — Philips Ingenuity CT  Product Codes: Ingenuity CT Upgrades 728327,   Ingenuity CT China 728324,  Ingenuity Core 128 Elite Brazil 728325.   Software 4.4.10.x","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-3042-2026%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":99,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3042-2026\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 Ingenuity CT  Product Codes: Ingenuity CT Upgrades 728327,   Ingenuity CT China 728324,  Ingenuity Core 128 Elite Brazil 728325.   Software 4.4.10.x\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:  Ingenuity CT Upgrades (01)00884838098701, Ingenuity CT China (01)00884838059863, Ingenuity Core 128 Elite Brazil: N/A\n\n## Distribution\nUS and US Territories."}