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Recall Observatory FDA recall evidence

Device product

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.

Z-2165-2024

June 05, 2024

Class I

Product summary

Firm
Philips North America Llc
Event
Event 94786
Status
Ongoing
Classification
Class I
Quantity
14 units
Official record key
device-enforcement:Z-2165-2024

Official wording

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

Code information: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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