{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "82093", "product_res_number": "Z-0479-2011", "event_date_initiated": "2009-01-21", "event_date_posted": "2010-11-26", "recall_status": "Terminated", "event_date_terminated": "2010-12-30", "res_event_number": "52100", "product_code": "KPR", "k_numbers": [ "K031535" ], "product_description": "Product's marketing brochure is labeled in part: \"Philips Easy Diagnost Eleva Conventional R/F system...PHILIPS\". manufactured by Philips Medical Systems Gmbh, Hamburg, Germany.", "code_info": "Site Numbers:  506250, 506251, 506276, 519152, 520209, 521153, 530573, 530607, 532426, 532779, 533491, 533574, 534207, 534419, 534644, 534647, 534675, 534803, 534945, 535378, 535437, 535785, 536051, 536458, 536522, 536636, 536637, 536687, 536765, 536840, 536933, 536941, 536973, 536985, 536994, 537013, 537087, 537091, 537179, 537186, 537492, 537518, 537571, 537689, 537761, 537796, 537803, 537863, 537945, 537946, 537970, 537971, 538237, 538328, 538351, 538407, 538451, 538458, 538462, 538477, 538480, 538519, 538759, 538812, 538814, 538866, 538891, 538901, 539040, 539095, 539101, 539103, 539237, 539291, 539310, 539339, 539377, 539378, 539379, 539411, 539419, 539488, 539501, 539519, 539527, 539529, 539530, 539557, 539590, 539683, 539785, 540022, 540163, 540187, 540361, 540380, 540445, 540457, 540459, 540624, 540788, 540810, 541011, 541054, 541063, 541078, 541083, 541093, 541348, 541402, 541494, 541535, 541614, 541694, 541721, 541803, 541838, 541850, 541872, 541884, 542061, 542121, 542122, 542205, 542308, 542401, 542521, 542537, 542589, 542593, 542716, 542829, 542849, 543136, 543144, 543224, 543241, 543249, 543275, 543297, 543331, 543369, 543415, 543426, 543619, 543620, 543660, 543723, 543754, 543755, 543771, 543776, 543803, 543841, 544075, 544113, 544172, 544228, 544236, 544297, 544341, 544417, 544480, 544481, 544568, 544648, 544654, 544695, 544937, 544999, 545000, 545038, 545120, 545163, 545166, 545213, 545231, 545234, 545244, 545391, 545452, 545710, 545746, 545780, 545783, 545824, 545844, 545923, 545948, 545951, 546029, 546155, 546490, 546524, 546551, 546583, 546602, 547054, 547189, 547243, 547297, 547304, 547371, 547598, 547599, 547655, 547657, 547744, 547758, 547759, 547798, 547936, 547937, 548021, 548276, 548290, 548302, 548382, 548559, 548784, 549008, 549080, 549269, 549270, 549381, 549416, 549509, 549557, 549616, 549663, 550072, 550079, 550197, 550313, 550591, 550804, 550936, 550960, 551005, 551416, 551573, 551616, 551645, 551721, 551759, 551941, 551954, 551980, 552204, 552205, 552211, 552324, 552363, 552364, 552407, 552502, 552579, 552594, 552626, 552640, 552917, 552918, 552965, 552966, 553013, 553172, 553207, 553224, 553230, 553275, 553349, 553387, 553441, 553448, 553455, 553563, 553850, 553893, 553900, 553926, 554061, 554483, 554581, 554641, 554721, 554722, 554769, 555052, 555269, 555458, 555524, 555574, 555626, 555964, 555993, 556124, 556621, 556622, 556726, 556785, 556984, 557177, 557259, 557272, 558437, 558596, 558734, 558775, 41443799, 41444441, 41658234, 41862667, 42039161, and 537967 / 49371595.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems North America Co. Phillips", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Philips Healthcare Call Center\n800-722-9377", "reason_for_recall": "Patient and image data can be exchanged when a patient is selected in the patient list and the examination tab is pressed with background query running at the same time. There is a risk that the data may then be linked to the incorrect patient, which may adversely affect diagnosis and treatment.", "root_cause_description": "Software design", "action": "Philips Medical Systems issued URGENT-Device Correction letters dated January 27, 2009 to consignees describing the issue with the Easy Diagnost Eleva GXR RF systems. The consignees were informed of the potential for incorrect diagnosis or treatment if an incorrect image is used for diagnosis. \nConsignees should contact the Philips Healthcare Call Center at 800-722-9377, #5, #2 and reference \"FC0 70600030\" with any communication.", "product_quantity": "314 units", "distribution_pattern": "Nationside Distribution: USA, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PA, RI, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, and WV. \nDevices are not distributed to any foreign consignees.", "openfda": { "k_number": [ "K972766", "K060550", "K945278", "K913711", "K071409", "K233532", "K152244", "K143257", "K090279", "K062634", "K760205", "K853753", "K133259", "K101779", "K810973", "K790070", "K143270", "K202572", "K180543", "K884477", "K242847", "K880352", "K190601", "K973710", "K912517", "K072659", "K872468", "K091747", "K913659", "K101686", "K904147", "K934005", "K770060", "K210692", "K880982", "K232178", "K233543", "K813173", "K150725", "K984111", "K191699", "K231892", "K855161", "K091889", "K072010", "K993962", "K102408", "K122589", "K220271", "K091752", "K182134", "K233722", "K800788", "K233530", "K113248", "K123098", "K904676", "K260482", "K942792", "K936087", "K161937", "K912515", "K150165", "K230800", "K173517", "K162529", "K954196", "K250790", "K013826", "K872316", "K233920", "K101435", "K981056", "K071401", "K132294", "K140683", "K940306", "K781613", "K001341", "K182517", "K103050", "K193089", "K063246", "K012546", "K102284", "K133959", "K981657", "K082798", "K011111", "K083503", "K152788", "K201825", "K071408", "K191418", "K231761", "K250738", "K926554", "K071403", "K163115", "K181629", "K081722", "K123105", "K242478", "K192541", "K242019", "K862616", "K180765", "K122119", "K001201", "K073650", "K973219", "K841756", "K250954", "K173828", "K071392", "K050151", "K102349", "K063247", "K803049", "K941592", "K900562", "K250788", "K192364", "K913757", "K883160", "K926069", "K203537", "K090238", "K872317", "K942581", "K083109", "K861994", "K972000", "K854110", "K033345", "K153119", "K122454", "K172229", "K111655", "K852349", "K945708", "K214012", "K902606", "K172869", "K944613", "K811230", "K841923", "K193574", "K950980", "K200944", "K120034", "K073632", "K080614", "K061595", "K150663", "K121345", "K120752", "K062405", "K080553", "K092307", "K162224", "K981880", "K082604", "K052943", "K990298", "K133496", "K223550", "K941931", "K253446", "K110828", "K201725", "K083181", "K102680", "K141837", "K810797", "K872525", "K192453", "K883834", "K242119", "K982824", "K923455", "K902791", "K160620", "K042876", "K140332", "K990715", "K140334", "K192293", "K811934", "K242499", "K970136", "K142049", "K982196", "K132934", "K902378", "K202394", "K182622", "K121854", "K173953", "K223842", "K933512", "K082064", "K915362", "K771051", "K934755", "K093816", "K151219", "K142930", "K160857", "K193360", "K781473", "K870400", "K121109", "K040995", "K102123", "K201640", "K811807", "K101042", "K151419", "K933778", "K203340", "K251167", "K022737", "K082261", "K151924", "K220919", "K982955", "K811215", "K201670", "K150816", "K233662", "K123106", "K811142", "K791374", "K920347", "K952672", "K191879", "K181279", "K870300", "K193225", "K203345", "K921112", "K071546", "K993090", "K152767", "K920558", "K001336", "K992066", "K062417", "K904146", "K080582", "K231995", "K051967", "K863309", "K233719", "K141381", "K935649", "K803130", "K790741", "K121513", "K910757", "K945709", "K043025", "K180663", "K220518", "K110849", "K102285", "K241068", "K081836", "K103448", "K201373", "K781983", "K230241", "K192079", "K913435", "K182880", "K013481", "K990242", "K150506", "K812332", "K113855", "K183541", "K213700", "K802200", "K051258", "K133695", "K974112", "K072867", "K052541", "K220149", "K023008", "K012389", "K071430", "K022667", "K790685", "K122726", "K152294", "K182183", "K962896", "K162971", "K193637", "K800564", "K160997", "K221853", "K931071", "K140326", "K853330", "K202388", "K011486", "K921539", "K173823", "K182647", "K151685", "K213057", "K190330", "K904145", "K071402", "K860025", "K963941", "K974863", "K080655", "K974597", "K933023", "K173612", "K112670", "K953832", "K092830", "K212186", "K083640", "K152813", "K242678", "K143029", "K233381", "K223060", "K062335", "K202156", "K993665", "K790740", "K033577", "K050704", "K952871", "K181413", "K031535", "K980296", "K922813", "K163203", "K142773", "K252000", "K790069", "K202293", "K070678", "K073114", "K163410", "K833559", "K012165", "K083510" ], "registration_number": [ "9614430", "3042864600", "3012624817", "3007305589", "3009608361", "3011950073", "1064396", "3005172103", "3008364043", "9616047", "3009001657", "3012127758", "2126677", "3031503890", "3003775006", "3004077520", "8022065", "1450503", "3011015597", "3008284470", "3023003446", "3011955679", "9617251", "3004485675", "3009717300", "1054713", "3014209556", "3035950510", "3003768277", "1418484", "3016250464", "3001722928", "3010300212", "9613445", "2433615", "3006551157", "3003202425", "3006051164", "3004606964", "3004198450", "3005406110", "3011416394", "3021059265", "3009134655", "3011825597", "3012569470", "3033527770", "3005810333", "3000126629", "1418964", "3006165260", "3032116890", "2243057", "3009715136", "3030089787", "3001556265", "3008496839", "3014403439", "3027339477", "3025442726", "3009077524", "9616014", "3009529630", "3009963139", "3033525986", "3004977335", "3004756607", "3029916061", "3013714596", "3006115340", "3016674851", "3023190435", "3024891354", "3013679558", "3003769120", "3005778458", "3003768251", "3004989804", "3014293172", "3015276088", "1317307", "8030112", "8030233" ], "fei_number": [ "3042864600", "3012624817", "3007305589", "3009608361", "3011950073", "3005172103", "3008364043", "3009001657", "3012127758", "3002143662", "2126677", "3031503890", "3003775006", "3004077520", "3003434037", "1450503", "3011015597", "3008284470", "3023003446", "3011955679", "3004485675", "3009717300", "3002808139", "3014209556", "3035950510", "1418484", "3016250464", "3001722928", "3010300212", "2433615", "3006551157", "3003202425", "3006051164", "3004606964", "3004198450", "3005406110", "3011416394", "3021059265", "3009134655", "3011825597", "3012569470", "3033527770", "1000114111", "3005810333", "3000126629", "3002495042", "3002885429", "1418964", "3006165260", "3032116890", "2243057", "3003377038", "3009715136", "3030089787", "3001556265", "3008496839", "3014403439", "3027339477", "3025442726", "3009077524", "3009529630", "3002675731", "3009963139", "3033525986", "3004977335", "3004756607", "3029916061", "3013714596", "3006115340", "3016674851", "3023190435", "3024891354", "3013679558", "3003769120", "3002175190", "3005778458", "3003768251", "3002807880", "3004989804", "3014293172", "3015276088", "3005116291", "1317307" ], "device_name": "System, X-Ray, Stationary", "medical_specialty_description": "Radiology", "regulation_number": "892.1680", "device_class": "2" } } ] }