{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73474", "product_res_number": "Z-0456-2009", "event_date_initiated": "2008-09-25", "event_date_posted": "2008-12-03", "recall_status": "Terminated", "event_date_terminated": "2008-12-03", "res_event_number": "49460", "product_code": "HGM", "k_numbers": [ "K993008" ], "product_description": "GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mother-Baby and the Neonatal Intensive Care Unit; GE Healthcare Integrated IT Solutions, Barrington, IL 60010\n\nIntended for use as a clinical data management system.", "code_info": "software version 6.80.0 only with Alert and Reminder feature activated", "firm_fei_number": "3004526608", "recalling_firm": "GE Healthcare Integrated IT Solutions", "address_1": "540 W Northwest Hwy", "city": "Barrington", "state": "IL", "postal_code": "60010-3051", "additional_info_contact": "GE Customer Care Center\n800-437-1171", "reason_for_recall": "Software anomalies in the Alert and Reminder feature could result in a delay of treatment. When attempting to select the last visible alert or reminder choice, the next choice on the list below the desired choice is selected, and an inconsistent color may be displayed for the same clinical element across a set of work stations.", "root_cause_description": "Software design", "action": "The software was updated to version 6.80.1 on 4/22/08, however, the consignee was notified of the software defects relating to the last visible Alerts and Reminders choice and the inconsistent display for the same clinical element across a set of work stations, via Product Safety Notification letter dated 8/29/08, sent via first class mail on 9/24/08. If there were any questions, the customer was to contact Tech Support at 1-800-433-2009.", "product_quantity": "1 unit", "distribution_pattern": "Nationwide Distribution --- state of Ohio.", "openfda": { "k_number": [ "K051175", "K761201", "K010552", "K771379", "K812863", "K831115", "K870692", "K060230", "K882966", "K790139", "K102140", "K010889", "K900480", "K871383", "K171865", "K902690", "K241009", "K173941", "K013281", "K771196", "K921956", "K970456", "K072976", "K892501", "K121267", "K171178", "K813007", "K935377", "K912890", "K023931", "K960109", "K955931", "K123335", "K043597", "K832849", "K771194", "K110556", "K940898", "K910169", "K200975", "K011304", "K761030", "K912639", "K121758", "K790761", "K142883", "K965008", "K861189", "K071800", "K110612", "K231964", "K090269", "K871082", "K050234", "K150398", "K963608", "K112159", "K032252", "K042082", "K111083", "K132918", "K173715", "K781359", "K780176", "K770296", "K770297", "K073221", "K843385", "K821479", "K103545", "K800013", "K220732", "K905295", "K121208", "K902802", "K903992", "K052190", "K021135", "K254036", "K012718", "K931133", "K932077", "K010894", "K964770", "K904358", "K925572", "K120018", "K860237", "K831371", "K892354", "K030261", "K002548", "K253021", "K994008", "K813457", "K040903", "K100420", "K791037", "K801747", "K992607", "K993008", "K823188", "K153580", "K111614", "K855044", "K103172", "K791035", "K894036", "K991905", "K141194", "K052795", "K050826", "K112187", "K150901", "K920376", "K954351", "K813458", "K831852", "K910418", "K935301", "K112317", "K241882", "K831113", "K142799", "K852704", "K910260", "K791038", "K043598", "K983395", "K822830", "K880419", "K771195", "K132650", "K852076", "K770692", "K934959", "K081203", "K761139", "K002503", "K860295", "K844724", "K823081", "K821580", "K082369", "K851252", "K014094", "K894958", "K950420", "K852518", "K092028", "K895045", "K905606", "K091251", "K893981", "K812256", "K971099", "K100358", "K842422", "K100797", "K760919", "K001677", "K871385", "K080226", "K102263", "K831114", "K090285", "K143695", "K780177", "K821478", "K882084", "K090061", "K781360", "K082602", "K990569", "K991739", "K001882", "K942887", "K140535", "K791039", "K912138", "K241368", "K050583", "K052715", "K993751", "K861455", "K021574", "K843918", "K841477", "K131941", "K173042", "K955559", "K233440", "K043075", "K023618", "K891595", "K040819", "K100885", "K002150", "K250777", "K963711", "K222327", "K861544", "K040788", "K032772", "K771541", "K852608", "K102958", "K161902", "K921957", "K861556", "K980719", "K960553", "K974248", "K791036", "K062137" ], "registration_number": [ "3013546957", "9610816", "3010698831", "3010395077", "2132111", "1000589001", "3006104191", "2028916", "3014220748", "1000122786", "3021635975", "9617277", "3007309299", "3007048259", "3013783488", "3000126629", "9710602", "3004167720", "3016618143", "3013500228", "9680215", "3001570235", "3012528160", "1218950", "3016701404", "3007607999", "3008729547", "3012359877", "1000576299", "1066270", "3006179052", "3004423584", "3013596024", "3008717264", "1424263", "1930027", "3007734888", "3009499478", "3036470679", "3010611950", "3008403701", "9615396", "1450908", "3009077524", "9610105", "3015529350", "3010390468", "9681377", "3013400897", "3014541700", "3003971136", "3003681187", "3004566918", "1121996", "3004526608" ], "fei_number": [ "3013546957", "3010698831", "3010395077", "1000589001", "3006104191", "3014220748", "1000140026", "1000300598", "1000122786", "3021635975", "3003190524", "3007309299", "3007048259", "3013783488", "3000126629", "3001084824", "1000142646", "3004167720", "3016618143", "3013500228", "3001570235", "3012528160", "1218950", "3016701404", "3007607999", "3008729547", "3012359877", "1000576299", "3003015552", "3006179052", "3004423584", "3013596024", "3008717264", "1930027", "3007734888", "3002806783", "3003513129", "3009499478", "3036470679", "3010611950", "3002687025", "3008403701", "1450908", "3009077524", "3000957797", "3015529350", "3010390468", "3013400897", "3014541700", "3003971136", "3003681187", "3004566918", "3002807167", "1121996", "3004526608" ], "device_name": "System, Monitoring, Perinatal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.2740", "device_class": "2" } } ] }