{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210875", "product_res_number": "Z-0540-2025", "event_date_initiated": "2024-11-04", "event_date_posted": "2024-11-25", "recall_status": "Open, Classified", "res_event_number": "95645", "product_code": "MOS", "k_numbers": [ "K032576" ], "product_description": "dS Breast 7ch 3.0T", "code_info": "REF: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729911, 459801729912, 459801729913; UDI-DI: 00884838066168, 00884838086173, 00884838098404, 00884838107953, 00884838118294; Serial No. 1050, 632, 709, 981, 944, 1060, 175, 703, 723, 1009, 102, 209, 227, 365, 514, 342, 509, 742, 753, 801, 819, 1013, 462, 903, 912, 833, 868, 843, 884, 892, 1002, 1038, 182, 170, 946, 980, 747, 219, 626, 907, 827, 840, 861, 854, 890, 871, 860, 850, 878, 891, 859, 894, 883, 889, 926, 863, 880, 909, 910, 988, 904, 888, 902, 966, 913, 929, 998, 935, 896, 928, 932, 943, 959, 958, 1051, 1041, 972, 1011, 982, 997, 978, 991, 992, 995, 987, 1062, 1008, 1004, 747, 999, 1029, 1044, 1014, 1063, 1036, 1057, 1058, 220, 297, 337, 339, 343, 543, 545, 615, 607, 602, 685, 623, 635, 619, 670, 496, 633, 229, 614, 628, 642, 624, 680, 717, 644, 676, 705, 682, 707, 792, 697, 776, 727, 704, 715, 713, 757, 805, 731, 770, 803, 754, 775, 778, 756, 751, 768, 689, 761, 794, 793, 799, 779, 773, 815, 814, 930, 990, 938, 205, 893, 1061, 858, 609, 538, 767, 135, 127, 977, 812, 893, 879, 692, 22, 617, 816, 832, 877, 51, 82, 93, 66, 103, 223, 148, 239, 234, 421, 612, 422, 232, 1000, 168, 106, 798, 117, 744, 876, 925, 927, 684, 810, 864, 874, 1030, 985, 677, 746, 169, 83, 146, 190, 145, 211, 208, 212, 230, 241, 235, 567, 618, 608, 802, 898, 866, 165, 181, 688, 1027, 215, 763, 905, 911, 882, 706, 640, 745, 811, 808, 837, 836, 849, 844, 856, 867, 881, 931, 924, 960, 948, 968, 983, 1010, 620, 622, 625, 396, 630, 612, 681, 696, 636, 643, 684, 687, 725, 726, 720, 741, 743, 797, 831, 809, 824, 847, 855, 899, 865, 852, 934, 895, 906, 897, 964, 965, 845, 1043, 1033, 1042, 85, 139, 177, 149, 185, 253, 147, 118, 172, 226, 206, 184, 238, 195, 228, 218, 221, 240, 194, 342, 497, 60, 302, 260, 244, 261, 254, 512, 293, 341, 600, 460, 583, 423, 509, 616, 627, 526, 764, 77, 461, 679, 551, 237, 845, 1040, 139, 171, 139, 171, 701, 846, 885, 698, 777, 144, 236, 188, 213, 310, 634, 700, 691, 971, 718, 61, 996, 183, 233, 817, 368, 647, 686, 848, 1059, 258, 510, 396, 732, 78, 842, 791, 821, 933, 962, 969, 1006, 749, 869, 936, 176, 367, 172, 886, 719, 804, 857, 949, 728, 975, 695, 830, 527, 825, 908, 631, 699, 716, 721, 774, 755, 796, 826, 823, 841, 961, 951, 920, 1045, 1001, 1012, 1047, 993, 47, 9, 189, 124, 338, 366, 550, 542, 552, 581, 224, 1028, 750, 772, 1053, 820, 851, 1003, 166, 340, 629, 722, 862, 989, 795, 994, 52, 511, 613, 937, 683, 639, 710, 689, 730, 614, 887, 967, 957, 1034, 17, 58, 36, 59, 8, 116, 99, 81, 151, 92, 91, 126, 101, 79, 128, 150, 125, 23, 167, 210, 152, 207, 229, 217, 216, 242, 222, 243, 380, 496, 426, 526, 195, 541, 252, 637, 769, 71, 2052, 2075, 2073, 2095, 2032, 2086, 2011, 2019, 2070, 2102, 2074, 2010, 2041, 2021, 2088, 2013, 2025, 2098, 2042, 2024, 2046, 2017, 2063, 2050, 2087, 2106, 2062, 2097, 2047, 2072, 2085, 2071, 2037, 2058, 2084, 2093, 2069, 2108, 2099, 2103, 2091, 2083, 2027, 2107, 2051, 2100, 2035, 2043, 2105, 2023, 2034, 2036, 2043, 2061, 2110, 2038, 2040, 2048, 2016, 2022, 2049, 2039, 2059, 2030, 2045, 2033, 2031, 2060, 2064, 2076, 2051, 2037, 2028, 2018, 2094, 2068, 2030, 2014, 2012, 2112, 2053, 2015, 2090, 2026, 2044, 2096, 2109, 251, 17, 210, 44, 66, 108, 155, 55, 40, 119, 98, 128, 69, 112, 233, 113, 139, 100, 185, 137, 171, 170, 159, 183, 223, 181, 247, 235, 201, 240, 264, 256, 241, 222, 70, 56, 68, 16, 199, 118, 105, 75, 83, 10, 103, 63, 76, 73, 65, 85, 50, 254, 135, 121, 61, 34, 84, 79, 62, 80, 46, 64, 77, 158, 86, 95, 120, 74, 109, 114, 132, 111, 81, 97, 64, 164, 140, 131, 143, 165, 187, 163, 192, 173, 200, 184, 177, 190, 206, 172, 232, 194, 209, 208, 198, 220, 255, 228, 253, 213, 231, 248, 217, 239, 195, 246, 238, 268, 122, 138, 175, 263, 37, 13, 41, 160, 87, 218, 156, 205, 234, 244, 250, 204, 245, 58, 265, 154, 211, 227, 96, 54, 267, 92, 266, 99, 35, 82, 49, 90, 142, 133, 225, 257, 230, 30, 38, 32, 104, 110, 117, 157, 116, 124, 134, 229, 237, 219, 93, 51, 174, 102, 221, 33, 261, 48, 216, 243, 207, 60, 176, 161, 249, 59, 115, 67, 91, 101, 178, 188, 182, 191, 214, 242, 236, 36, 180, 127, 224, 123, 94, 31, 45, 260, 125, 130, 169, 258, 162, 252, 144, 186, 166, 47, 226, 203, 42, 57, 202, 215, 89, 129, 167, 179, 1123, 1159, 1119, 1312, 1308, 1136, 1128, 1115, 1060, 1162, 1086, 1169, 1007, 1084, 1088, 1054, 1087, 1083, 1062, 1075, 1076, 1116, 1192, 1104, 1132, 1168, 1180, 1152, 1153, 1107, 1331, 1307, 1135, 1196, 1324, 1268, 1340, 1008, 1052, 1318, 1271, 1056, 1130, 1096, 1080, 1089, 1059, 1077, 1066, 1064, 1078, 1103, 1057, 1055, 1079, 1091, 1092, 1102, 1163, 1141, 1114, 1148, 1134, 1097, 1109, 1120, 1099, 1110, 1183, 1131, 1094, 1137, 1154, 1195, 1184, 1188, 1158, 1178, 1138, 1122, 1175, 1274, 1108, 1142, 1164, 1149, 1150, 1182, 1215, 1176, 1179, 1277, 1121, 1266, 1337, 1272, 1173, 1214, 1310, 1267, 1265, 1144, 1216, 1270, 1275, 1325, 1327, 1334, 1350, 1311, 1349, 1069, 1022, 1273, 1317, 1146, 1278, 1185, 1269, 1316, 1345, 1342, 1280, 1157, 1061, 1329, 1309, 1347, 1170, 1151, 1070, 1098, 1143, 1320, 1187, 1140, 1071, 1095, 1106, 1127, 1058, 1166, 1124, 1313, 1161, 1165, 1217, 1186, 1346, 1326, 1343, 1197, 1065, 1156, 1139, 1118, 1081, 1145, 1174, 1323, 1262, 1171, 1085, 1073, 1067, 1105, 1330, 1193, 1315, 1172, 1167, 1101, 1090, 1341, 1314, 1126, 1053, 1322, 1063, 1111, 1133, 1117, 1072, 1125, 1279, 1321, 1335, 1068, 1129, 1280, 1332, 1107, 1333, 1264, 1328, 1348, 1264, 1093, 27, 52, 29, 98, 25, 48, 44, 71, 65, 132, 20, 49, 81, 61, 5, 146, 43, 8, 47, 26, 78, 143, 32, 13, 137, 57, 34, 38, 30, 11, 39, 50, 46, 140, 181, 122, 58, 68, 74, 142, 76, 123, 101, 111, 125, 186, 97, 105, 165, 169, 172, 138, 147, 148, 150, 180, 168, 154, 176, 187, 188, 163, 19, 28, 23, 141, 18, 51, 63, 56, 107, 67, 106, 89, 99, 144, 170, 184, 164, 160, 124, 21, 55, 93, 158, 91, 85, 84, 109, 139, 133, 103, 127, 117, 136, 112, 182, 62, 54, 171, 24, 9, 31, 45, 69, 190, 4, 131, 178, 70, 102, 128, 36, 60, 83, 151, 96, 121, 108, 80, 72, 104, 110, 183, 173, 135, 82, 166, 119, 77, 95, 152, 159, 189, 14, 41, 59, 66, 120, 145, 174, 7, 162, 6, 17, 130, 88, 2, 35, 177, 185, 1, 179, 64, 175, 92, 33, 134, 162, 40, 10, 16, 22, 42, 94, 149, 87, 153, 161, 15, 29, 139, 101, 19, 12, 17, 4, 10, 8, 71, 53, 109, 103, 69, 7, 25, 96, 50, 6, 15, 77, 47, 64, 28, 70, 73, 132, 168, 163, 126, 121, 180, 62, 39, 68, 26, 95, 49, 48, 89, 162, 165, 157, 100, 128, 145, 93, 87, 160, 142, 94, 107, 136, 177, 83, 21, 80, 105, 36, 79, 148, 13, 129, 114, 110, 138, 78, 173, 135, 119, 86, 159, 90, 127, 118, 14, 56, 99, 32, 175, 104, 72, 88, 5, 164, 146, 131, 111, 82, 155, 181, 167, 143, 174, 123, 20, 166, 133, 179, 125, 149, 169, 140, 27, 23, 150, 60, 74, 153, 76, 59, 1, 113, 158, 33, 182, 124, 18, 151, 106, 85, 130, 170, 172, 52, 134, 98, 55, 102, 171, 147, 92, 16, 108, 141, 115, 176, 137, 144, 54, 75, 9, 2, 34, 42, 30, 40, 37, 178, 66, 35, 156, 11, 3, 152, 120, 112, 61, 76, 24, 20, 41, 39, 22, 30, 35, 2, 18, 17, 38, 43, 23, 37, 72, 11, 65, 40.", "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": "Customer Care Solution Center\n1-800-722-9377", "reason_for_recall": "Potential safety issue where a patient may be harmed while preparing for or during a scan.", "root_cause_description": "Use error", "action": "An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at Philips.Recall@philips.com. Customers with any questions are to contact their local Philips Representative.", "product_quantity": "5,231 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K003386", "K190668", "K253738", "K964854", "K002345", "K001210", "K061715", "K993233", "K022372", "K100670", "K994345", "K081322", "K062767", "K120290", "K023982", "K120627", "K121362", "K042207", "K010802", "K231647", "K994042", "K091047", "K001312", "K020790", "K990007", "K130457", "K111259", "K013322", "K222325", "K984257", "K040937", "K050621", "K030540", "K110487", "K022883", "K052497", "K030953", "K223487", "K982916", "K082373", "K072873", "K051349", "K022007", "K103274", "K021433", "K061952", "K032576", "K042009", "K070778", "K092962", "K984588", "K010513", "K042103", "K172222", "K050514", "K000935", "K113365", "K023084", "K213397", "K050622", "K953595", "K983109", "K244054", "K093842", "K992650", "K022487", "K233600", "K033753", "K982339", "K091546", "K243316", "K010946", "K052584", "K211658", "K113474", "K111802", "K983143", "K001209", "K982972", "K003097", "K950966", "K024352", "K001944", "K032618", "K181697", "K072874", "K021631", "K122897", "K032633", "K022588", "K140998", "K093667", "K103335", "K972592", "K982496", "K111251", "K022669", "K032538", "K061950", "K002482", "K090267", "K093284", "K021751", "K180123", "K111060", "K173446", "K024187", "K200477", "K103275", "K073131", "K133506", "K002774", "K223378", "K223239", "K093693", "K961628", "K031089", "K123327", "K013541", "K162079", "K231085", "K252876", "K100113", "K981094", "K974308", "K103365", "K162946", "K182737", "K023596", "K111673", "K083539", "K213727", "K033152", "K103149", "K013810", "K021575", "K093689", "K260947", "K163661", "K001303", "K991765", "K142755", "K071847", "K051512", "K180666", "K050299", "K040122", "K031366", "K040349", "K023247", "K022863", "K013099", "K021141", "K083541", "K033567", "K254190", "K003340", "K193140", "K140606", "K162029", "K130706", "K142002", "K011608", "K162651", "K242096", "K020993", "K083434", "K081340", "K013508", "K000002", "K022582", "K022395", "K060401", "K030371", "K031119", "K223225", "K081118", "K080820", "K012728", "K163205", "K031143", "K052200", "K121249", "K024209", "K003655", "K142676", "K173290", "K955626", "K002522", "K001946", "K033292", "K071179", "K061170", "K052704", "K031095", "K260519", "K213735", "K232762", "K112313", "K103506", "K242879", "K151829", "K020850", "K181948", "K023442", "K010140", "K003331", "K102748", "K993719", "K961525", "K972205", "K963356", "K982978", "K023679", "K182590", "K083086", "K121910", "K042844", "K013595", "K213351", "K030495", "K052621", "K002864", "K072935", "K140282", "K984272", "K041145", "K100141", "K072931", "K040640", "K052045", "K162966", "K161193", "K001097", "K964678", "K191539", "K071534", "K150331", "K013594", "K220144", "K020036", "K152695", "K062556", "K031139", "K083578", "K081745", "K112112", "K252179", "K252587", "K954190", "K002602", "K964820", "K964813", "K160932", "K954952", "K042718", "K213480", "K021262", "K012353", "K032429", "K993235", "K160935", "K033490", "K151753", "K050307", "K971246", "K984278", "K112366", "K082916", "K102348", "K030317", "K022720", "K002539", "K981406", "K970868", "K213687", "K024208", "K983139", "K964668", "K002483", "K262330", "K052916", "K253182", "K021330", "K003685", "K063513", "K031056", "K013528", "K091114", "K993780", "K042342", "K060873", "K003613", "K011781", "K000549", "K973630", "K110120", "K110591", "K243428", "K093348", "K103342", "K241069", "K023848", "K003436", "K041487", "K991740", "K212239", "K082987", "K223484", "K122638", "K201101", "K112002", "K082636", "K033353", "K173377", "K022910", "K041481", "K003505", "K052827", "K041921", "K073236", "K073310", "K071966", "K013985", "K080120", "K081198", "K020606", "K182504", "K123272", "K003144", "K101632", "K991434", "K980157", "K982921", "K243033", "K031172", "K952944", "K980691", "K023164", "K014086", "K162623", "K001331", "K162001", "K011683", "K110373", "K991115", "K123091", "K123492", "K993898", "K163066", "K080062", "K032474", "K001870", "K013592", "K083255", "K993776", "K031365", "K063373", "K110411", "K002916", "K041185", "K020495", "K982919", "K063342", "K983222", "K003946", "K021570", "K233444", "K994040", "K052077", "K040348", "K032090", "K961391", "K060547", "K982772", "K071611", "K120122", "K981959", "K031209", "K013854", "K053042", "K053017", "K162177", "K032045", "K033151", "K994315", "K060689", "K010074", "K162863", "K171515", "K072909", "K003366", "K151653", "K091902", "K133986", "K000993", "K112293", "K010730", "K083160", "K000437", "K042617", "K060758", "K002860", "K262294", "K000345", "K233656", "K121911", "K001713", "K032415", "K073181", "K101492", "K122646", "K132444", "K052585", "K172695", "K182958", "K993477", "K101949", "K013514", "K133422", "K993819", "K042186", "K183111", "K110610", "K113280", "K031536", "K013159", "K023929", "K083014", "K013894", "K232021", "K070629", "K051763", "K141832", "K024354", "K222407", "K972296", "K991724", "K964969", "K994436", "K033235", "K030042", "K200836", "K233348", "K223429", "K213766", "K101858", "K971667", "K964141", "K122694", "K173469", "K001582", "K061281", "K050476", "K973787", "K071882", "K033662", "K972340", "K991057", "K993279", "K140252", "K020601", "K022488", "K984159", "K994378", "K051618", "K243675", "K183186", "K071311", "K013602", "K233652", "K143389", "K123681", "K991113", "K083166", "K212864", "K142802", "K103185", "K123708", "K992193", "K974438", "K050728", "K102889", "K023571", "K000589", "K040288", "K971016", "K222257", "K023650", "K012491" ], "registration_number": [ "1835830", "3011950073", "3014809646", "2011171", "3010949642", "9613936", "1054811", "1932898", "3032109225", "9614698", "3007137598", "3031503890", "3008414621", "3023003446", "3035950510", "3005877899", "3011015597", "2183553", "3007350713", "3010326005", "3018423337", "3014343100", "3009514037", "9616047", "3029521953", "3012439308", "3016851825", "3012085143", "3012761544", "3042177665", "3004977335", "3004754211", "3009714754", "3015431711", "1043549", "3026047529", "3008632256", "2029275", "3015276088", "3009755250", "3013875850", "3005049692", "2183744", "3009656988", "3014635027", "3009970070", "1058584", "3009529630", "3010132318", "3028006458", "3006239787", "3010703925", "3009077524", "3008355361", "3006369484", "3021244844", "3021059265", "3015329423", "3002808157", "3008986341", "3005326970", "3006262888", "3008284470", "1529041", "3027339477", "3036666444", "3009196578", "3004531751", "3017375271", "3009963139", "3007562060", "3000126629", "3004929307", "3014310698", "3003768277", "3012169560" ], "fei_number": [ "3011950073", "3014809646", "2011171", "3010949642", "3001814065", "1000306431", "3007137598", "1000219637", "3032109225", "3031503890", "3003377038", "3008414621", "1000158431", "3023003446", "3035950510", "3005877899", "3011015597", "2183553", "3007350713", "3010326005", "3018423337", "3014343100", "3009514037", "3029521953", "3012439308", "1000571342", "3016851825", "3012085143", "3012761544", "3042177665", "3004977335", "3004754211", "3005214683", "3009714754", "3015431711", "1043549", "3026047529", "3008632256", "3002807880", "1000114185", "3015276088", "3009755250", "3013875850", "3005049692", "2183744", "3009656988", "3014635027", "3009970070", "3009529630", "3028006458", "3010132318", "3006239787", "3010703925", "3009077524", "3008355361", "3006369484", "3021244844", "3021059265", "3015329423", "3002808157", "3008986341", "3005326970", "3006262888", "3008284470", "3027339477", "3036666444", "3009196578", "3004531751", "3017375271", "3009963139", "3007562060", "3000126629", "3002808382", "3004929307", "3014310698", "3012169560" ], "device_name": "Coil, Magnetic Resonance, Specialty", "medical_specialty_description": "Radiology", "regulation_number": "892.1000", "device_class": "2" } } ] }