{"url_path":"/fda/device/recalls/Z-2650-2026","section_key":"summary","section_title":"DEVICE Recall: PHILIPS MEDICAL SYSTEMS — Brilliance iCT   Brilliance iCT Upgrades  Brilliance iCT SP  Brilliance CT 64 Channel  CT6000  Brilliance 64 Upgrades","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-11","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2650-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"PHILIPS MEDICAL SYSTEMS"},"word_count":114,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2650-2026\n\n**Recalling firm:** PHILIPS MEDICAL SYSTEMS\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** FDA Mandated\n**Initiated:** 2026-06-11\n**Report date:** 2026-08-05\n\n## Product\nBrilliance iCT   Brilliance iCT Upgrades  Brilliance iCT SP  Brilliance CT 64 Channel  CT6000  Brilliance 64 Upgrades\n\n## Reason\nThe 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.\n\n## Affected lots\nFCO72800812; FCO72800814  728305 728306 DI (01)00884838059474 728307 DI (01)00884838104600 728311  728231 (01)00884838083325  728232\n\n## Distribution\nUS Nationwide Distribution including Puerto Rico"}