FDAFDA · Food and drugs·Recall number Z-2163-2024
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.
Published July 3, 2024 · Recall initiated: June 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for coils to heat up and harm patients (burn).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- Worldwide distribution: US (Nationwide) and OUS (Foreign): Afghanistan, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Papua New Guinea, Peru, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, T¿rkiye, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam.
- Lot
- UDI-DI: N/A. 1. Model Number 453567141882. Serial Numbers: 137, 141, 145, 147, 157, 18, 188, 19, 191, 197, 251, 291, 301, 320, 356, 360, 364, 366, 371, 39, 394, 40, 408, 418, 428, 434, 446, 464, 468, 470, 471, 472, 557, 95, 124, 352, 303, 328, 315, 443, 2, 412, 215, 358, 300, 427, 175, 421, 300202352, 432, 429, 469, 313, 365. 2. Model Number 453567141883. Serial Numbers: 113, 134, 137, 140, 152, 153, 174, 196, 197, 20, 204, 205, 228, 234, 235, 26, 37, 40, 41, 42, 44, 70, 92, 93, 95, 80, 52, 162, 24, 116, 58, 82, 47, 96, 46, 15. 3. Model Number 989603014351. Serial Numbers: IBA_CD_2012, 629, 240, 530, 203, 408, 494, 638. 4. Model Number 989603014352. Serial Numbers: 288, 843, 743, 895, 1169, 1204, 1262, 1003, 500, 1197, 1150, 921, 1063, 1107, 1098, 1120, 1138, 1133, 1139, 1155, 1170, 1156, 1177, 1183, 1187, 1190, 1205, 1212, 1298, 1244, 1247, 1269, 1266, 1274, 1299, 1315, 1283, 457, 844, 1181, 1224, 1258, 1257, 1249, 1073, 440, 465, 429, 1289, 1252, 334, 363, 980, 928, 1092, 1323, 709, 614, 192, 540, 708, 647, 1246, 711, 754, 816, 569, 896, 656, 415, 550, 702, 574, 359, 1147, 712, 1186, 256, 954, 988, 1035, 1055, 411, 968, 327, 586, 819, 450, 1223, 937, 923, 470, 1288, 634, 1027, 715, 1242, 885, 471, 468, 399, 1038, 518, 612, 306, 1117, 661, 289, 1234, 637, 1116, 489, 684, 678, 681, 1128, 813, 1278, 887, 1051, 562, 834, 483, 1113, 773, 1091, RS416, 1185, 662, 568, 572, 1238, 1232, 1094, 180, 1235, 793, 677, 682, 267, 796, 810, 777, 906, 349, 328, 410, 594, 414, 185, 791, 950, 526, 305, 549, 720, 1124, 331, 802, 528, 1200, 663, 343, 706, 753, 458, 539, 650, 600, 1085, 557, 655, 615, 728, 913, 1324, 506, 1049, 1157, 504, 536, 424, 689, 752, 613, 184, 760, 181, 566, 908, 1325, 396, 879, 853, 1194, 1078, 405, 1292, 861, 644, 395, 962, 996, 792, 762, 651, 841, 1062, 246, 302, 840, 982, 1207, 1229, 1074, 1162, 496, 804, 739, 849, 517, 719, 441, 798, 660, 953, 1167, 1225, 1219, 1294, 498, 1182, 1184, 1103, 1202, 674, 693, 960, 1149, 606, 1018, 858, 989, 1259, 878, 1312, 1215, 778, 1037, 1295, 700, 1080, 931, 1281, 278, 1058, 924, 951, 784, 1104, 499, 790, 869, 868, 344, 890, 476, 313, 299, 1189, 1125, 1284, 617, 1168, 666, 1129, 428, 1148, 375, 460, 597, 1302, 1303, 454, 867, 197, 1196, 1280, 1272, 1277, 947, 332, 485, 871, 765, 735, 725, 1217, 1108, 1253, 511, 687, 883, 935, 1311, 909, 899, 444, 377, 824, 341, 742, 654, 856, 290, 1203, 701, 970, 1060, 710, 473, 1064, 218, 1008, 894, 1045, 975, 1054, 665, 806, 783, 704, 547, 1301, 1135, 800, 939, 695, 199, 205, 1241, 963, 209, 1059, 916, 605, 204, 308, 749, 516, 1119, 337, 748, 1095, 717, 925, 832, 966, 683, 734, 977, 942, 1046, 587, 671, 339, 1021, 385, 1270, 995, 976, 653, 623, 884, 1132, 741, 1195, 945, 1171, 865, 215, 774, 991, 955, 1114, 325, 262, 434, 1254, 1015, 372, 281, 635, 667, 1005, 639, 585, 1122, 537, 676, 439, 543, 488, 697, 383, 964, 1172, 904, 857, 1016, 559, 565, 736, 626, 625, 679, 624, 973, 675, 696, 652, 721, 690, 862, 874, 915, 911, 771, 912, 1158, 999, 892, 1028, 756, 948, 632, 998, 1211, 1048, 1255, 781, 738, 932, 1033, 1042, 936, 1075, 917, 1123, 919, 855, 956, 927, 1050, 889, 910, 891, 1209, 946, 852, 1066, 901, 1230, 967, 1118, 459, 1034, 1099, 1070, 990, 1077, 1072, 978, 961, 801, 1039, 1071, 1061, 1263, 983, 877, 926, 1069, 974, 1032, 1040, 1052, 342, 872, 1086, 1020, 1228, 888, 822, 1250, 1100, 1068, 1293, 831, 1314, 1233, 1240, 1251, 336, 992, 713, 1227, 729, 882, 1319, 406, 1067, 1213, 1286, 922, 993, 522, 758, 714, 1214, 859, 987, 694, 907, 668, 789, 1141, 902, 1102, 464, 1271, 1081, 794, 645, 699, 576, 972, 1276, 376, 315, 827, 1089, 905, 836, 997, 1275, 1206, 698, 830, 930, 1083, 479, 1121, 669, 1140, 1191, 257, 914, 558, 751, 1096, 1090, 805, 1267, 692, 940, 823, 1024, 1101, 1014, 846, 1176, 553, 618, 409, 1126, 447, 456, 1151, 231, 680, 971, 965, 817, 222, 1239, 1265, 691, 1164, 938, 803, 412.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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