{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "81932", "product_res_number": "Z-1479-2009", "event_date_initiated": "2009-05-12", "event_date_posted": "2009-06-26", "recall_status": "Terminated", "event_date_terminated": "2020-09-23", "res_event_number": "52026", "product_code": "HGM", "k_numbers": [ "K071800" ], "product_description": "Philips Avalon Fetal Monitor FM30; Model Number: M2703A.", "code_info": "Units with serial numbers in the range of DE53001002 through DE53107383.", "firm_fei_number": "1218950", "recalling_firm": "Philips Healthcare Inc.", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "978-687-1501", "reason_for_recall": "Interruption of power-up/boot sequence may cause the paper scale and recorder speed settings of the monitor to revert to factory default may lead to misinterpretation of the fetal trace by the user and to potential incorrect clinical decisions", "root_cause_description": "Software change control", "action": "Philips Healthcare issued an \"Urgent-Medical Device Correction\" notification dated May 15, 2009 to Customers in the United States via UPS and notifications outside the US will be managed by Philips representatives in each affected geography. Customers were asked to follow the guidelines in the Action to be Taken by Customer/User section of the Correction Notice until they receive their software upgrade.\n\nQuestions can be made to Philips response center at 1-800-722-9377.", "product_quantity": "4,788 units", "distribution_pattern": "Worldwide Distribution", "openfda": { "k_number": [ "K844724", "K852608", "K935377", "K001882", "K121267", "K173941", "K790139", "K021135", "K870692", "K921957", "K112317", "K964770", "K250777", "K052715", "K103172", "K861189", "K990569", "K993751", "K253021", "K043598", "K072976", "K902802", "K894036", "K043597", "K103545", "K100358", "K912890", "K882966", "K131941", "K771541", "K781359", "K954351", "K871385", "K842422", "K102958", "K032772", "K043075", "K770297", "K994008", "K090269", "K153580", "K851252", "K140535", "K050583", "K110612", "K942887", "K761139", "K801747", "K882084", "K934959", "K241882", "K050234", "K910169", "K771194", "K080226", "K971099", "K052190", "K171178", "K030261", "K062137", "K121758", "K052795", "K823188", "K831115", "K831113", "K023618", "K832849", "K980719", "K920376", "K040819", "K771379", "K222327", "K791039", "K955931", "K904358", "K241009", "K902690", "K821479", "K910260", "K111083", "K132918", "K852518", "K112187", "K032252", "K791035", "K780177", "K831852", "K132650", "K100797", "K970456", "K121208", "K821478", "K813007", "K905606", "K993008", "K843918", "K813458", "K200975", "K002150", "K921956", "K771195", "K861556", "K931133", "K233440", "K082602", "K143695", "K974248", "K051175", "K812863", "K891595", "K800013", "K791036", "K040788", "K770296", "K822830", "K060230", "K823081", "K955559", "K001677", "K091251", "K010894", "K161902", "K791037", "K905295", "K940898", "K011304", "K171865", "K841477", "K040903", "K932077", "K010552", "K050826", "K900480", "K861544", "K895045", "K910418", "K861455", "K991739", "K852076", "K761030", "K173715", "K935301", "K963608", "K220732", "K081203", "K120018", "K983395", "K254036", "K871383", "K831371", "K950420", "K082369", "K231964", "K871082", "K855044", "K110556", "K013281", "K090061", "K852704", "K860237", "K813457", "K073221", "K791038", "K925572", "K023931", "K892354", "K843385", "K112159", "K831114", "K860295", "K770692", "K761201", "K991905", "K912639", "K780176", "K042082", "K021574", "K142883", "K965008", "K173042", "K821580", "K894958", "K102263", "K150901", "K141194", "K892501", "K142799", "K771196", "K014094", "K790761", "K903992", "K912138", "K002548", "K071800", "K123335", "K012718", "K893981", "K760919", "K100420", "K102140", "K963711", "K090285", "K241368", "K010889", "K960109", "K781360", "K111614", "K100885", "K002503", "K812256", "K150398", "K992607", "K092028", "K880419", "K960553" ], "registration_number": [ "3004566918", "3007048259", "3010611950", "3009499478", "9680215", "3003681187", "1424263", "3009077524", "3013500228", "3004526608", "3013783488", "3010390468", "3004167720", "3014220748", "3021635975", "2028916", "3004423584", "3007309299", "9681377", "3014541700", "3008729547", "1450908", "3007734888", "1000576299", "3001570235", "9615396", "3015529350", "3008717264", "9710602", "3036470679", "3010395077", "3015976667", "3012359877", "3013400897", "1218950", "9617277", "1121996", "3016701404", "1930027", "3006179052", "3013546957", "1000122786", "1066270", "3000126629", "3016618143", "3010698831", "3013596024", "9610105", "3007607999", "3012528160", "9610816", "3006104191", "2132111", "1000589001", "8020045", "3003971136", "3008403701" ], "fei_number": [ "3004566918", "3007048259", "3010611950", "3009499478", "3003681187", "3009077524", "3003015552", "3013500228", "3004526608", "3013783488", "3010390468", "3004167720", "3014220748", "3021635975", "3004423584", "3007309299", "1000142646", "3014541700", "3008729547", "1450908", "3007734888", "1000576299", "6736", "3001570235", "3015529350", "3008717264", "3036470679", "3010395077", "3015976667", "3012359877", "1000300598", "3013400897", "1218950", "3003513129", "3002687025", "3002807167", "1121996", "3016701404", "1930027", "3006179052", "3013546957", "1000122786", "1000140026", "3000126629", "3016618143", "3010698831", "3013596024", "3003190524", "3007607999", "3012528160", "3006104191", "3001084824", "1000589001", "3002806783", "3000957797", "3003971136", "3008403701" ], "device_name": "System, Monitoring, Perinatal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.2740", "device_class": "2" } } ] }