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SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips M...

FDA Device Recall #Z-2163-2024 — Class I — June 5, 2024

Recall Summary

Recall Number Z-2163-2024
Classification Class I — Serious risk
Date Initiated June 5, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips North America Llc
Location Cambridge, MA
Product Type Devices
Quantity 729 units

Product Description

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.

Reason for Recall

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

Distribution Pattern

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 / Code Information

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.

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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