{"url_path":"/fda/device/recalls/Z-2652-2026","section_key":"summary","section_title":"DEVICE Recall: PHILIPS MEDICAL SYSTEMS — Ingenuity CT  CT5000 Ingenuity Plus  CT5000 Ingenuity Pro  CT5000 Ingenuity Premium  Ingenuity CT Upgrades  Ingenuity CT China  Ingenuity Core 128 Elite Brazil","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-2652-2026%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":125,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2652-2026\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\nIngenuity CT  CT5000 Ingenuity Plus  CT5000 Ingenuity Pro  CT5000 Ingenuity Premium  Ingenuity CT Upgrades  Ingenuity CT China  Ingenuity Core 128 Elite Brazil\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\nFCO72800815, FCO72800816, 728321 DI (01)00884838059498 728323 DI (01)00884838059504 728326 DI (01)00884838059511 728327 DI (01)00884838098701 728324 DI (01)00884838059863 728325\n\n## Distribution\nUS Nationwide Distribution including Puerto Rico"}