{ "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": 1 } }, "results": [ { "cfres_id": "130271", "product_res_number": "Z-0105-2015", "event_date_initiated": "2014-10-03", "event_date_posted": "2014-10-21", "recall_status": "Terminated", "event_date_terminated": "2017-01-31", "res_event_number": "69348", "product_code": "HGM", "k_numbers": [ "K111083" ], "product_description": "Philips Avalon Monitors with software revision J.30.58: \n\nModel\t\tProduct\nFM20\t\tM2702A ;\nFM30\t\tM2703A ;\nFM50\t\tM2705A\n\nIntended for: \" Monitoring the physiological parameters of pregnant women \" Non-invasive monitoring of fetal heart rates and movements.", "code_info": "software revision J.30.58:", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems, Inc.", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "Same\n978-687-1501", "reason_for_recall": "Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped", "root_cause_description": "Software Design Change", "action": "Philips Healthcare issued on 10/3/14 the Urgent Medical Device Correction notification/Field Safety Notice. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.\nThe correction will consist of a software upgrade free of charge.\nA Philips Healthcare representative will contact customers with affected devices to arrange for service. \n\nPhilips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice:\n\nDuring the interim period until the SW is upgraded please make sure, if the NBP repetition interval needs to be increased (e.g. from 5 to 15 minutes), to restart the automatic NBP measurement.\n\nPlease review this information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.", "product_quantity": "118 units", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA AUSTRIA BAHRAIN BELGIUM CHINA COLOMBIA CZECH REPUBLIC DENMARK FINLAND FRANCE GERMANY HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN KAZAKHSTAN NETHERLANDS NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN POLAND ROMANIA RUSSIA SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UKRAINE and UNITED KINGDOM.", "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" } } ] }