SENSE XL TORSO COIL 3.0T. 16-element receive only coil recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: N/A. 1. Model Number 453567394941. Serial Number: 9. 2. Model Number 453567394942. Serial Numbers: 40000, 100, 102, 104, 144, 192, 84, 98, 42. 3. Model Number 453567394943. Serial Numbers: 301, 228, 761, 87, 880, 814, 0174R3, 541, @001@0179R3, 0141R3, 0172R3, 0189R3, 0260R3, 0265R3, 0285R3, 0358R3, 116R3, 121, 127, 149, 152, 158, 165, 176, 180, 213R3, 216, 220, 224, 235, 237, 263, 265, 267, 273, 274, 286, 294, 298, 302, 303, 310R3, 312, 313, 316, 328R3, 336, 346, 359, 360, 374, 377, 382, 389, 400, 406, 421, 423, 424, 43, 431, 45, 454, 455, 460, 464, 466, 474, 477, 481, 488, 496, 505, 511, 513, 518, 523, 543, 549, 564, 576, 582, 592, 597, 602, 603, 61, 610, 611, 617R3, 627, 632, 633, 635, 642, 657, 658, 666r3, 669, 670, 672, 685, 686, 694, 708, 710, 716, 720, 726, 729, 732, 736, 745, 757, 761, 763, 780, 782, 783, 788, 793, 800, 828, 84, 861, 87, 880, 887, 89, 907, 908, 913, 924, 926, 932, 939, 947, 956, 961, 967. 4. Model Number 453567394945. Serial Numbers: 104, 107, 108, 117, 129, 145, 165, 166, 178, 180, 198, 201, 211, 22, 222, 225, 229, 242, 268, 31, 336, 35, 42, 64, 69, 87, 916, 94. 5. Model Number 459801593182. Serial Numbers: 116, 141, 165, 211, 100, 103, 104, 110, 112, 123, 124, 127, 128, 13, 131, 133, 134, 136, 142, 143, 144, 145, 146, 148, 15, 150, 156, 158, 164, 167, 168, 172, 173, 174, 179, 183, 186, 192, 193, 194, 195, 198, 199, 20, 204, 208, 21, 217, 221, 225, 23, 230, 232, 240, 241, 246, 249, 251, 253, 254, 26, 262, 264, 265, 266, 268, 275, 278, 279, 28, 288, 294, 297, 298, 303, 306, 311, 312, 313, 315, 321, 324, 326, 330, 339, 34, 340, 344, 345, 346, 349, 350, 352, 354, 355, 357, 361, 362, 365, 368, 370, 39, 40, 42586, 44, 52, 53, 57, 6, 60, 62, 63, 64, 66, 705, 71, 72, 79, 80, 88, 932, 94, 97. 6. Model Number 989603050641. Serial Numbers: 152, 169, 179, 88, 83, 109, 105, 130, 176. 7. Model Number 989603050642. Serial Numbers: 529, 509, 217, 189, 127, 311, 85, 531, 534, 546, 561, 347, 609, 296, 142, 110, 391, 137, 20, 28, 160, 378, 370, 172, 202, 76, 272, 326, 404, 167, 94, 446, 560, 521, 497, 353, 515, 386, 369, 253, 571, 220, 333, 362, 265, 426, 442, 469, 74, 31, 284, 533, 147, 248, 259, 69, 330, 270, 525, 611, 102, 309, 461, 52, 191, 203, 108, 8, 100, 524, 381, 503, 389, 283, 360, 53, 348, 448, 490, 556, 22, 380, 247, 59, 554, 589, 580, 403, 507, 226, 452, 183, 357, 224, 472, 39, 221, 435, 16, 480, 266, 255, 445, 588, 1, 128, 466, 32, 124, 133, 276, 329, 431, 443, 598, 227, 584, 14, 449, 295, 513, 168, 535, 40, 17, 48, 104, 51, 177, 64, 287, 9, 394, 174, 494, 201, 50, 482, 590, 350, 438, 487, 365, 297, 368, 57, 196, 432, 551, 310, 12, 242, 250, 249, 240, 366, 382, 18, 390, 320, 129, 604, 314, 545, 437, 58, 583, 175, 367, 274, 510, 512, 573, 131, 505, 44, 599, 47, 595, 398, 206, 593, 564, 495, 619, 54, 30, 122, 552, 312, 161, 254, 275, 282, 387, 123, 335, 364, 570, 607, 166, 91, 384, 379, 436, 508, 193, 474, 407, 575, 577, 608, 601, 356, 188, 232, 324, 430, 422, 455, 155, 195, 321, 300, 361, 194, 208, 338, 418, 214, 99, 243, 492, 317, 581, 103, 237, 340, 401.

Product

SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers…

Recalling firm

Philips North America Llc

Quantity

307 units

Distribution

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.

Recall date

July 3, 2024

Classification

Class I

Status

Ongoing

Agency

FDA (device)