{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "220769", "product_res_number": "Z-2522-2026", "event_date_initiated": "2026-05-26", "event_date_posted": "2026-06-22", "recall_status": "Open, Classified", "res_event_number": "99084", "product_code": "HGM", "k_numbers": [ "K140535" ], "product_description": "Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A", "code_info": "UDI/DI 00884838000407, Serial Numbers: DE79569306, DE79569332, DE79569360, DE79569417, DE79569442, DE79569482, DE79569307, DE79569470, DE79569390, DE79569356, DE79569452, DE79569289, DE79569302, DE79569536, DE79569358, DE79569343, DE79569457, DE79569353, DE79569373, DE79569411, DE79569491, DE79569615, DE79569287, DE79569338, DE79569437, DE79569459, DE79569473, DE79569340, DE79569308, DE79569377, DE79569286, DE79569304, DE79569327, DE79569330, DE79569347, DE79569352, DE79569400, DE79569418, DE79569431, DE79569436, DE79569456, DE79569469, DE79569474, DE79569588, DE79569326, DE79569424, DE79569487, DE79569547, DE79569290, DE79569258, DE79569367, DE79569370, DE79569380, DE79569388, DE79569311, DE79569440, DE79569460, DE79569527, DE79569462, DE79569299, DE79569261, DE79569405, DE79569260, DE79569313, DE79569369, DE79569216.", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Philips Customer Services\n800-722-9377", "reason_for_recall": "Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.", "root_cause_description": "Process control", "action": "Philips issued an URGENT Medical Device Correction notice to its consignees on 5/26/2026 via USPS certified mail. The notice explained the issue and how it can be identified, potential risk to the patient should the loss of audio is not detected, and requested the following: \n\"Actions that should be taken by the customer / user in order to prevent risks for\npatients or users \n\" Ensure fetal heart rate tones are enabled on the Avalon Fetal Monitor until the planned\nfix/correction is implemented. \n\" Pass this notice to all those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred. \n\" Place this Urgent Medical Device Correction with the documentation of the Philips Avalon Fetal Monitor and associated devices in a place where it is most likely to be seen and viewed.\"", "product_quantity": "285 units", "distribution_pattern": "Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.", "openfda": { "k_number": [ "K831115", "K861455", "K991905", "K843385", "K902690", "K821478", "K021574", "K110556", "K910260", "K071800", "K921957", "K983395", "K112187", "K010894", "K993751", "K925572", "K001882", "K960109", "K861556", "K954351", "K042082", "K823081", "K780177", "K935301", "K942887", "K761139", "K082369", "K892354", "K002548", "K173941", "K112159", "K880419", "K950420", "K111614", "K790761", "K761201", "K871385", "K781359", "K021135", "K851252", "K770692", "K111083", "K843918", "K142799", "K893981", "K253021", "K895045", "K852076", "K900480", "K010889", "K970456", "K142883", "K852608", "K904358", "K852704", "K905606", "K040819", "K090285", "K051175", "K882084", "K921956", "K121267", "K771194", "K964770", "K771379", "K861189", "K121758", "K132918", "K231964", "K112317", "K831852", "K052795", "K171865", "K080226", "K903992", "K120018", "K934959", "K920376", "K812863", "K912890", "K241882", "K050826", "K813458", "K241368", "K222327", "K171178", "K770297", "K912639", "K023618", "K103545", "K100358", "K043598", "K971099", "K102140", "K023931", "K860295", "K870692", "K812256", "K052715", "K852518", "K821580", "K014094", "K791036", "K882966", "K032772", "K090061", "K791037", "K102263", "K241009", "K220732", "K813007", "K780176", "K173715", "K791039", "K254036", "K082602", "K150398", "K992607", "K091251", "K032252", "K761030", "K073221", "K771541", "K960553", "K791038", "K892501", "K010552", "K963608", "K955559", "K994008", "K891595", "K823188", "K173042", "K161902", "K791035", "K030261", "K140535", "K110612", "K050583", "K771195", "K935377", "K790139", "K092028", "K102958", "K861544", "K131941", "K871082", "K043597", "K002503", "K250777", "K822830", "K855044", "K132650", "K781360", "K121208", "K090269", "K990569", "K841477", "K912138", "K860237", "K143695", "K040903", "K771196", "K100885", "K932077", "K760919", "K844724", "K123335", "K011304", "K905295", "K072976", "K141194", "K821479", "K980719", "K100420", "K103172", "K965008", "K813457", "K002150", "K894036", "K081203", "K963711", "K831113", "K910418", "K062137", "K001677", "K150901", "K993008", "K831114", "K012718", "K894958", "K013281", "K043075", "K060230", "K842422", "K940898", "K974248", "K902802", "K831371", "K200975", "K931133", "K100797", "K800013", "K991739", "K801747", "K153580", "K050234", "K770296", "K040788", "K871383", "K233440", "K910169", "K955931", "K052190", "K832849" ], "registration_number": [ "1930027", "9680215", "3003681187", "3006179052", "3013500228", "9617277", "9610816", "1121996", "3014220748", "3014541700", "3010611950", "3008717264", "1000576299", "3004566918", "3000126629", "1066270", "3013783488", "3008729547", "3012359877", "3001570235", "3007734888", "3006104191", "3007607999", "3007309299", "1000122786", "3016618143", "1000589001", "3013546957", "3015976667", "3004423584", "9615396", "3015529350", "3010395077", "3021635975", "1218950", "3004167720", "3009077524", "2028916", "9710602", "2132111", "3007048259", 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"device_name": "System, Monitoring, Perinatal", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.2740", "device_class": "2" } } ] }