{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "86576", "product_res_number": "Z-1193-2010", "event_date_initiated": "2009-11-02", "event_date_posted": "2010-03-23", "recall_status": "Terminated", "event_date_terminated": "2013-05-23", "res_event_number": "53816", "product_code": "MKJ", "k_numbers": [ "K050004" ], "product_description": "Philips Heartstart FRx automated external defibrillator (AED), Model 861304", "code_info": "DOMESTIC UNIT SERIAL NUMBERS - B09J-00860, B09J-00792, B09J-00810, B09J-00877, B09J-00878, B09J-00793, B09J-01110, B09J-00849, B09J-01016, B09J-01196, B09J-01299, B09J-00855, B09J-00805, B09J-01193, B09J-00896, B09J-00824, B09J-00821, B09J-00823, B09J-00825, B09J-00835, B09J-02749, B09J-00794, B09J-00856, B09J-00889, B09J-00891, B09J-00897, B09J-01005, B09J-01012, B09J-01197, B09J-01230, B09J-01269, B09J-01279, B09J-00791, B09J-00818, B09J-00875, B09J-01082, B09J-01100, B09J-01260, B09J-01010, B09J-01018, B09J-01021, B09J-01022, B09J-01108, B09J-01114, B09J-01120, B09J-01080, B09J-01014, B09J-01298, B09J-01300, B09J-01257, B09J-00872, B09J-00803, B09J-00804, B09J-00868, B09J-01013, B09J-01019, B09J-01020, B09J-01123, B09J-01258, B09J-00786, B09J-00817, B09J-00790, B09J-00816, B09J-01122, B09J-01162, B09J-00789, B09J-00795, B09J-00798, B09J-00806, B09J-00807, B09J-00808, B09J-00842, B09J-00847, B09J-00879, B09J-00892, B09J-01002, B09J-01003, B09J-01006, B09J-01007, B09J-00813, B09J-00819, B09J-00820, B09J-00853, B09J-00884, B09J-01015, B09J-01139, B09J-01252, B09J-01259, B09J-00787, B09J-01253, B09J-01303, and B09J-00898. 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B09J-02156, B09J-02161, B09J-02162, B09J-02168, B09J-02171, B09J-02179, B09J-02261, B09J-02263, B09J-02265, B09J-02269, B09J-02272, B09J-02273, B09J-02276, B09J-02278, B09J-02280, B09J-02281, B09J-02320, B09J-02328, B09J-02333, B09J-02416, B09J-02426, B09J-02429, B09J-02519, B09J-02527, B09J-02528, B09J-02530, B09J-02531, B09J-02532, B09J-02535, B09J-02539, B09J-02543, B09J-02545, B09J-02546, B09J-02547, B09J-02553, B09J-02559, B09J-02830, B09J-02831, B09J-02949, B09J-01335, B09J-01339, B09J-01344, B09J-01346, B09J-01502, B09J-01504, B09J-01505, B09J-01509, B09J-01511, B09J-01517, B09J-01521, B09J-01525, B09J-01526, B09J-01528, B09J-01672, B09J-01673, B09J-01694, B09J-01698, B09J-01096, B09J-01191, B09J-01231, B09J-01232, B09J-01236, B09J-01237, B09J-01238, B09J-01242, B09J-01249, B09J-01250, B09J-01306, B09J-01307, B09J-01308, B09J-01309, B09J-01311, B09J-01312, B09J-01314, B09J-01316, B09J-02386, B09J-02396, B09J-02448, B09J-02746, B09J-02803, B09J-02906, B09J-02917, B09J-02923, B09J-02932, B09J-01248, B09J-01305, B09J-01310, B09J-01313, B09J-01315, B09J-01320, B09J-01321, B09J-01322, B09J-01324, B09J-01325, B09J-01326, B09J-01328, B09J-01329, B09J-01330, B09J-01333, B09J-01336, B09J-01337, B09J-01340, B09J-01342, B09J-01343, B09J-01097, B09J-01240, B09J-01241, B09J-01245, B09J-01079, B09J-01332, B09J-01334, B09J-01338, B09J-01347, B09J-01503, B09J-01508, B09J-01510, B09J-01514, B09J-01522, B09J-01666, B09J-01671, B09J-02497, B09J-02631, and B09J-02647.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems", "address_1": "2301 5th Ave Ste 200 2301 5th Ave", "address_2": "Ste 200", "city": "Seattle", "state": "WA", "postal_code": "98121", "additional_info_contact": "206-664-5290", "reason_for_recall": "Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm notified their US distributors of the recall and instructed them to contact customers and provide information how to return the product to Philips for a free replacement. Firm contacted distributors via phone and email on 11/2/09 and by letter on 11/9/09. A web site providing information related to the recall was activated on 11/3/09.", "product_quantity": "92 units distributed domestically, 452 units distributed internationally", "distribution_pattern": "Worldwide Distribution.", "openfda": { "k_number": [ "K954504", "K092598", "K022732", "K061707", "K143714", "K060559", "K072812", "K040256", "K011144", "K042404", "K993533", "K130153", "K021168", "K983287", "K040056", "K121853", "K003228", "K041883", "K091943", "K002280", "K033275", "K090989", "K013896", "K962359", "K892005", "K033771", "K992977", "K141231", "K002079", "K002806", "K942344", "K141774", "K030898", "K063375", "K012766", "K040438", "K940445", "K142803", "K040479", "K031987", "K123881", "K051134", "K983307", "K003565", "K860676", "K073089", "K032439", "K941262", "K020203", "K040637", "K042417", "K023854", "K050004", "K092391", "K003548", "K032421", "K131550", "K072430", "K955890", "K112432", "K020984", "K942850", "K062233", "K955923", "K883584", "K120406", "K926172", 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"3003491392", "3011823740", "3012972516", "1220908", "1000305720", "3003521780", "3000215273", "3009077524", "3012104670", "3010317211", "3043226252", "3008207730", "3004906872", "1000148701", "3017422354", "3003537036", "3012607778", "3010783192", "3013557562", "3013517171", "3010030355", "3010703925", "3012494290", "3007029079", "3004123209", "3013826848", "3005621729", "3006108746", "3026976873", "3030733800", "1317188", "3013596024", "3013500228", "1000127185", "3015876", "3015134086", "3003867964", "1000140026", "3009886119", "3008717264", "1000524572", "1720929", "3038259592", "3020460367", "3021632375", "3014579161", "3026007685", "3014572985", "3002714378", "3021559257", "3004035727", "1930027", "6736", "3012502601", "3001451571", "1921846", "3029871637", "1218058", "3003800159", "2112020", "3030446844", "3010839093" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }