FDAFDA · Food and drugs·Recall number Z-2164-2024
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: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.
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 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.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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