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FDAFDA · Food and drugs·Recall number Z-2165-2024

SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

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 453567502281. Serial Numbers: 190, 187, 71, 60, 24, 244, 36, 151, 245, 29, 128, 151, 167, 179, 185, 187, 190, 29, 32, 34, 36, 38, 51. 2. Model Number 453567502282. Serial Numbers: 112, 27, 66, 67, 68, 75. 3. Model Number 453567502283. Serial Numbers: 1025, 1028, 1029, 1031, 1036, 1050, 1052, 1054, 1064, 1104, 1106, 111, 1112, 1131, 1134, 1135, 115, 1151, 1152, 1195, 1205, 1213, 1217, 1219, 1350, 1354, 1359, 1366, 1367, 1395, 1411, 208, 221, 243, 257, 279, 289, 357, 362, 4, 426, 450, 478, 50, 514, 519, 527, 530, 535, 616, 618, 65, 650, 678, 690, 702, 703, 723, 724, 755, 778, 787, 790, 873, 874, 923, 927, 928, 954, 957, 959, 962, 964, 973, 980, 984. 4. Model Number 453567502284. Serial Numbers: 1043, 200, 0086R4, 0131R4, 01444R3, 0156R4, 0163R4, 0296R3, 0312R3, 0480R3, 0516R3, 0580R3, 0603R3, 0629R3, 0673R3, 0696R3, 0884R3, 0939R4, 0979R3, 1, 1000, 1001, 1003, 1005, 1012, 1017, 1019, 1023, 1027, 1030, 1032, 1041, 1049, 1053, 1055, 1058, 1060, 1062, 1065, 1066, 1068, 1071, 1072, 1073, 1075, 1077, 1080, 1083, 1089, 1095R3, 109R2, 11, 1100, 1102, 1109, 1124, 1129, 1130, 1144R3, 1175, 1178, 1180, 1181, 1189, 1193R3, 120, 122R1, 123, 1243, 1246, 1252, 1261, 1262, 1276, 1277, 1298, 1308, 1309, 1317, 1318, 1319, 133, 1332, 1333, 1339, 1352R3, 137R3, 138, 1383, 1386, 1401, 1402R3, 1404, 1407, 1413, 1414, 146, 1470, 1472, 1495, 1514, 1521, 166R3, 177, 194, 195, 248, 257R4, 276, 286R3, 296, 300408480000, 304, 318, 333, 339, 340, 340R3, 347, 351, 353, 355, 376R4, 386, 388R3, 461R3, 474311, 474847, 474879, 474889, 474890, 474892, 474935, 47856, 4R3, 680R3, 723R3, 73, 814R3, 83R2, 853R3, 869R3, 894, 91, 911, 912, 915, 917, 933, 937, 938, 942, 946, 951, 953, 963, 965, 968, 971, 975R3, 976, 979, 981, 985, 986, 987, 991R3, 992, 997. 5. Model Number 453567502285. Serial Numbers: 1224, 1349, 1389, 1488, 48, 5, 55, 6, 62, 7. 6. Model Number 453567502286. Serial Numbers: 168, 223, 231, 247, 272, 28, 308, 349, 391, 411, 422, 441, 449, 59, 74. 7. Model Number 459801585212. Serial Numbers: 117, 577, 689, 754, 77, 791, 796, 805, 949, 993, 1004, 1006, 1007, 101, 1013, 1014, 1015, 1016, 103, 1038, 1039, 1048, 105, 1056, 1057, 1059, 1061, 1067, 1074, 109, 110, 119, 12, 125, 126, 148, 154, 155, 156, 159, 161, 163, 17, 171, 172, 189, 199, 1DHL.70, 1DHL135, 1DHL837, 207, 2074634, 210, 212, 218, 219, 227, 230, 240, 24092023, 245, 252, 255, 258, 259, 266, 277, 278, 284, 285, 287, 290, 295, 299, 30102031, 309, 317, 319, 321, 323, 324, 325, 343, 369, 379, 379412369, 379412375, 380, 383, 388, 390, 395, 405, 409, 410, 414, 430, 433, 436, 445, 448, 456, 459, 459801585223, 459801585263, 459801585267, 475, 479, 49, 497, 499, 501, 502, 507, 508, 509, 510, 512, 516, 520, 524, 529, 531, 532, 533, 534, 539, 54, 540, 550, 552, 553, 555, 556, 563, 573, 574, 580, 581, 583, 586, 588, 591, 598, 606, 612, 613, 614, 615, 620, 622, 624, 625, 634, 636, 638, 639, 644, 655, 656, 659, 662, 664, 676, 677, 679, 681, 683, 684, 693, 695, 698, 701, 704, 709, 717, 72, 721, 722, 727, 738, 740, 741, 742, 743, 748, 750, 753, 76, 764, 766, 770, 772, 774, 775, 776, 777, 784, 785, 789, 798, 806, 811, 812, 814, 815, 818, 821, 829, 830, 831, 833, 838, 842, 843, 844, 845, 846, 85, 853, 857, 858, 862, 863, 865, 866, 867, 869, 875, 878, 879, 888, 889, 890, 891, 893, 895, 899, 900, 902, 903, 906, 919, 934, 935, 940, 945, 958, 9600515602, 9600515609, 978, 990, 991, 995, 996, 998, 999.
Risk classification
Class I
Area (FDA)
device
Country
United States

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