FDA Device Recall Z-2163-2024

Device

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.

Lot / serial / GTIN: 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.

Quantity: 729 units

Reason for recall

Potential for coils to heat up and harm patients (burn).

Recall record

Recall number

Z-2163-2024

Classification

Class I

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

Distribution

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.

Recall initiated

2024-06-05

Classified by FDA Center

2024-06-27

FDA published

2024-07-03

Recalling firm

Philips North America Llc

Firm location

Cambridge, MA