{"url_path":"/fda/device/recalls/Z-3043-2026","section_key":"summary","section_title":"DEVICE Recall: Philips North America Llc — Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.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-3043-2026%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":95,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3043-2026\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 CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.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\nBrilliance CT 64 Channel UDI (01)00884838083325. Brilliance CT 64 Upgrades UDI N/A.\n\n## Distribution\nUS and US Territories."}