{ "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": "64648", "product_res_number": "Z-0329-2008", "event_date_initiated": "2007-09-24", "event_date_posted": "2007-12-07", "recall_status": "Terminated", "event_date_terminated": "2012-05-03", "res_event_number": "44959", "product_code": "IZI", "k_numbers": [ "K033737" ], "product_description": "Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021", "code_info": "Serial numbers affected:  17, 21, 22, 39, 44, 48, 49, 52, 54, 60, 81, 83, 93, 107, 111, 118, 121, 122, 135, 141, 144, 145, 153, 159, 160, 163, 165, 166, 167, 168, 170, 175, 176, 178, 179, 183, 184, 186, 187, 190, 191, 195, 196, 202, 203, 207, 211, 212, 213, 214, 220, 222, 225, 230, 231, 232, 234, 239, 246, 248, 249, 250, 251, 252, 254, 255, 262, 263, 265, 269, 270, 272, 277, 278, 283, 285, 286, 287, 289, 294, 301, 302, 303, 304, 306, 308, 310, 314, 315, 318, 321, 326, 327, 332, 337, 340, 341, 343, 347, 361, 362, 366, 369, 376, 379, 384, 387, 388, 389, 396, 404, 423, 425, 426, 435, 439, 445, 458, 467, 468, 469, 470, 471, 472, 479, 490, 494, 498, 504, 512, 514, 515, 518, 520, 521, 523, 528, 532, 534, 535, 543, 545, 553, 554, 559, 560, 579, 582, 586, 587, 588, 591, 592, 593, 595, 596, 599, 601, 602, 604, 606, 609, 611, 612, 615, 616, 618, 622, 623, 625, 626, 627, 628, 632, 634, 637, 638, 641, 642, 647, 649, 651, 654, 655, 658, 661, 663, 664, 667, 668, 670, 671, 672, 673, 674, 675, 676, 677, 678, 679, 680, 681, 683, 685, 686, 689, 691, 692, 694, 700, 701, 702, 705, 706, 707, 709, 716, 718, 722, 723, 730, 731, 737, 738, 741, 742, 744, 746, 750, 751, 752, 753, 754, 759, 765, 766, 770, 771, 773, 774, 775, 776, 777, 778, 779, 780, 781, 782, 785, 786, 788, 789, 790, 796, 797, 800, 804, 806, 808, 810, 813, 816, 821, 822, 823, 825, 826, 827, 828, 829, 830, 840, 841, 842, 843, 844, 845, 847, 848, 849, 850, 851, 852, 853, 857, 860, 861, 862, 863, 878, 882, 882, 886, 888, 892, 893, 894, 895, 896, 903, 904, 905, 906, 907, 908, 910, 911, 912, 913, 914, 919, 920, 921, 923, 924, 927, 929, 930, 933, 934, 939, 942, 943, 953, 959, 960, 961, 962, 966, 968, 970, 971, 972, 976, 984, 991, 992, 993, 994, 1007, 1009, 1015, 1032, 1038, 1044, 1045, 1046, 1056, 1075, 1076, 1081, 1085, 1090, 1092, 1093, 1095, 1096, 1098, 1103, 1104, 1105, 1107, 1108, 1114, 1115, 1116, 1118, 1119, 1124, 1126, 1127, 1128, 1132, 1138, 1139, 1140, 1141, 1145, 1147, 1150, 1153, 1161, 1166, 1167, 1168, 1169, 1170, 1174, 1176, 1177, 1178, 1179, 1183, 1187, 1188, 1189, 1190, 1195, 1196, 1201, 1202, 1205, 1206, 1207, 1209, 1211, 1221, 1223, 1227, 1228, 1229, 1235, 1236, 1237, 1240, 1241, 1242, 1252, 1253, 1256, 1258, 1259, 1267, 1268, 1269, 1273, 1274, 1276, 1277, 1279, 1291, 1293, 1294, 1297, 1298, 1300, 1302, 1318, 1321, 1326, 1331, 1338, 1364, 1374, 18165, 43041, 43048, 43051, 43057, 43068, 43070, 43076, 43080, 43081, 43090, 43093, 1674122, 521, 9A, and CG22N41.", "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": "Sarah Baxter\n425-487-7602", "reason_for_recall": "Inaccurate anatomical measurements when using the optional SmartMask feature", "root_cause_description": "Device Design", "action": "The recalling firm sent customers an Urgent Device Correction notification letter dated 09/21/07 via certified mail - return receipt requested. This notification provided a short term work around for the device defect. For a permanent fix, the recalling firm is developing software update to check for mismatch at the start of a subtracted fluoroscopy run, and will contact customers to schedule an install. Installation is expected to begin 10/2007 and be completed 06/2008.", "product_quantity": "468 units", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K810183", "K041027", "K030139", "K842494", "K930635", "K230727", "K972229", "K181537", "K945375", "K231986", "K875374", "K914376", "K944952", "K942503", "K812238", "K100849", "K970525", "K042646", "K955519", "K915232", "K945449", "K904540", "K934496", "K033184", "K982203", "K945400", "K993765", "K853044", "K882358", "K903372", "K842495", "K133719", "K910370", "K063345", "K052039", "K973482", "K875379", "K926258", "K082907", "K922804", "K243077", "K932410", "K903371", "K911732", "K072591", "K940484", "K083745", "K933058", "K850455", "K991922", "K926082", "K903941", "K813588", "K970738", "K062360", "K974679", "K811149", "K936002", "K923112", "K875376", "K924137", "K883831", "K945540", "K060749", "K897115", "K182907", "K984545", "K234090", "K960575", "K031333", "K052076", "K110256", "K243645", "K971181", "K931184", 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