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.
Enforcement
- Recall Number
- Z-2164-2024
- 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 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.
Potential for coils to heat up and harm patients (burn).
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.
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.
307 units