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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