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.
Enforcement
- Recall Number
- Z-2165-2024
- 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 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.
Potential for coils to heat up and harm patients (burn).
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.
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.
14 units