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.
Enforcement
- Recall Number
- Z-2163-2024
- Event ID
- 94786
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 3, 2024
- Initiation Date
- June 5, 2024
- Classification Date
- June 27, 2024
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289, United States
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.
Potential for coils to heat up and harm patients (burn).
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.
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.
729 units