{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 28 } }, "results": [ { "cfres_id": "41713", "product_res_number": "Z-0035-06", "event_date_initiated": "2005-09-13", "event_date_posted": "2005-10-12", "recall_status": "Terminated", "event_date_terminated": "2006-08-07", "res_event_number": "33337", "product_code": "HGM", "product_description": "FETALGARD Lite Fetal Monitors, Model AP1S\n(Single Fetus Monitoring)", "code_info": "System Serial Numbers: FA002021 FA002022 FA002025 FA002027 FA002033 FA002020 FA002029 FA002005 FA002041 FA002044 FA002046 FA002112 FA002097 FA002117 FA002028 FA002047 FA002048 FA002118 FA002034 FA002093 FA002095 FA002116 FA002008 FA002023 FA002030 FA002031 FA002009 FA002098 FA002040 FA002092 FA002024 FA002114 FA002113 FA002115 FA002026 FA002032 FA001328", "firm_fei_number": "1220672", "recalling_firm": "Analogic Corporation", "address_1": "8 centennial industrial park centennial drive", "city": "Peabody", "state": "MA", "postal_code": "01960-7902", "additional_info_contact": "Dean Smith\n978-326-43333", "reason_for_recall": "Unit may not power up due to faulty circuit board", "root_cause_description": "Other", "action": "Analogic notified customers by letter dated 9/13/05. Distributors were requested to notify their accounts and return units for replacement of the main circuit board.", "product_quantity": "37 units", "distribution_pattern": "CT, PR\nForeign: Algeria, Chile,Ecudor, Mexico, South Africa, Vietnam, Russia, United Arab Emirates, Phillipines, Singapore, Korea, Malyasia", "openfda": { "k_number": [ "K082602", "K121208", "K023618", "K121758", "K132918", "K092028", "K831371", "K013281", "K141194", "K990569", "K813458", "K991905", "K983395", "K921957", "K091251", "K790761", "K791039", "K140535", "K771195", "K960553", "K905606", "K861556", "K021135", "K111614", "K920376", "K860237", "K102263", "K791036", "K142883", "K892501", "K791035", "K954351", "K841477", "K893981", "K910260", "K942887", "K052715", "K780176", "K241368", "K843385", "K161902", "K171178", "K040903", "K791038", "K760919", "K761139", "K100797", "K042082", "K250777", "K173941", "K891595", "K052190", "K851252", "K071800", "K812863", "K050826", "K023931", "K831114", "K860295", "K870692", "K994008", "K012718", "K871082", "K143695", "K100885", "K821580", "K903992", "K082369", "K080226", "K123335", "K103545", "K060230", "K052795", "K852076", "K935377", "K110556", "K081203", "K950420", "K040788", "K925572", "K100420", "K761030", "K882084", "K932077", "K010894", "K991739", "K880419", "K001882", "K780177", "K993008", "K010552", "K100358", "K980719", "K843918", "K253021", "K935301", "K111083", "K014094", "K072976", "K791037", "K822830", "K220732", "K142799", "K882966", "K823081", "K902690", "K963608", "K831115", "K813007", "K112159", "K855044", "K032772", "K900480", "K002150", "K241009", "K801747", "K043075", "K894036", "K153580", "K771194", "K090269", "K241882", "K030261", "K770692", "K852704", "K121267", "K871383", "K902802", "K852518", "K771541", "K963711", "K912138", "K790139", "K090285", "K010889", "K895045", "K761201", "K770297", "K852608", "K823188", "K800013", "K955559", "K821478", "K001677", "K173042", "K904358", "K090061", "K011304", "K894958", "K871385", "K110612", "K073221", "K200975", "K002548", "K120018", "K970456", "K103172", "K171865", "K974248", "K132650", "K993751", "K931133", "K971099", "K912890", "K831852", "K912639", "K910418", "K050234", "K771379", "K861455", "K921956", "K842422", "K771196", "K965008", "K062137", "K861189", "K964770", "K832849", "K043597", "K032252", "K905295", "K021574", "K910169", "K781359", "K222327", "K051175", "K821479", "K813457", "K050583", "K112317", "K831113", "K992607", "K940898", "K781360", "K770296", "K934959", "K861544", "K173715", "K812256", "K844724", "K131941", "K150901", "K102958", "K231964", "K960109", "K040819", "K892354", "K150398", "K955931", "K112187", "K043598", "K102140", "K233440", "K002503" ], "registration_number": [ "3006179052", "2028916", "1121996", "9617277", "9610816", "1424263", "3009077524", "3003681187", "3001570235", "3013400897", "3004167720", "9680215", "3014220748", "1000576299", "3006104191", "9615396", "1218950", "3008729547", "3021635975", "3009499478", "3007048259", "3013783488", "3010698831", "3008717264", "3004526608", "3036470679", "9710602", "3012359877", "3008403701", "1066270", "3010611950", "3007734888", "3016701404", "3013546957", "1450908", "3007309299", "3010390468", "3012528160", "9681377", "3013596024", "3007607999", "3014541700", "1000589001", "3016618143", "3004423584", "1000122786", "3010395077", "3013500228", "1930027", "3004566918", "3000126629", "9610105", "2132111", "3015529350", "3003971136" ], "fei_number": [ "3006179052", "3001084824", "1121996", "3003015552", "3009077524", "3003681187", "3001570235", "3013400897", "3004167720", "3002687025", "3014220748", "1000576299", "1000300598", "1000142646", "3006104191", "1218950", "3008729547", "3021635975", "3009499478", "3000957797", "3007048259", "3013783488", "3010698831", "3008717264", "3004526608", "3003190524", "3036470679", "3008403701", "3012359877", "3003513129", "3010611950", "3007734888", "3016701404", "3013546957", "1450908", "3002806783", "3010390468", "3012528160", "3007309299", "3013596024", "3007607999", "3014541700", "1000589001", "1000140026", "3016618143", "3004423584", "1000122786", "3010395077", "3013500228", "1930027", "3004566918", "3000126629", "3002807167", "3015529350", "3003971136" ], "device_name": "System, Monitoring, Perinatal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.2740", "device_class": "2" } } ] }