Philips North America Llc: Medical Device Recall in 2024 - (Recall #: Z-0538-2025)

dS Breast 16ch 3.0T

Class II

Potential safety issue where a patient may be harmed while preparing for or during a scan.

REF: 453530280731, 459801290741, 459801290741, 459801290744, 459801729891, 459801729892; UDI: 00884838065840, 00884838086197, 00884838098381, 00884838118041; Serial No. 538, 170, 437, 14, 124, 189, 291, 194, 516, 412, 154, 271, 536, 122, 190, 151, 1, 353, 577, 479, 446, 502, 522, 481, 583, 578, 608, 592, 160, 393, 421, 422, 438, 432, 540, 526, 470, 580, 477, 483, 586, 521, 133, 50, 440, 223, 461, 537, 517, 448, 550, 539, 573, 621, 628, 588, 152, 447, 389, 458, 498, 495, 141, 147, 609, 533, 400, 567, 505, 560, 391, 557, 371, 425, 442, 456, 459, 534, 582, 546, 584, 365, 367, 370, 360, 369, 317, 382, 394, 387, 407, 416, 441, 443, 462, 455, 467, 463, 468, 464, 515, 520, 504, 505, 574, 576, 547, 593, 594, 601, 595, 602, 599, 618, 134, 145, 137, 104, 48, 164, 253, 270, 193, 187, 242, 191, 252, 250, 278, 249, 316, 290, 302, 329, 372, 303, 269, 332, 333, 339, 314, 305, 364, 418, 428, 616, 27, 265, 381, 551, 615, 607, 128, 128, 390, 406, 554, 366, 413, 488, 499, 579, 174, 172, 165, 263, 500, 414, 544, 427, 549, 378, 460, 317, 445, 523, 552, 310, 311, 306, 449, 606, 424, 435, 524, 465, 466, 501, 530, 532, 546, 555, 541, 575, 566, 469, 588, 627, 590, 603, 340, 242, 375, 377, 388, 409, 434, 431, 444, 469, 509, 611, 127, 103, 158, 181, 318, 146, 358, 362, 357, 361, 506, 535, 619, 480, 523, 433, 361, 392, 401, 548, 571, 96, 123, 140, 296, 338, 313, 620, 380, 242, 439, 591, 383, 372, 558, 562, 600, 317, 356, 411, 426, 610, 173, 501, 396, 355, 379, 408, 410, 587, 612, 33, 47, 11, 124, 51, 135, 146, 36, 35, 105, 126, 143, 148, 159, 149, 150, 138, 162, 169, 176, 157, 218, 138, 294, 277, 363, 354, 335, 262, 373, 448, 15, 133, 107, 166, 20, 52, 22, 57, 67, 113, 112, 150, 156, 171, 168, 134, 172, 23, 24, 61, 93, 94, 19, 42, 74, 118, 155, 40, 116, 148, 140, 41, 100, 123, 127, 30, 10, 11, 38, 88, 21, 50, 66, 146, 71, 63, 28, 69, 59, 48, 75, 143, 126, 62, 125, 129, 122, 131, 9, 55, 54, 12, 157, 16, 101, 18, 60, 158, 58, 73, 68, 26, 31, 13, 17, 19, 34, 64, 65, 14, 175, 34, 119, 162, 130, 92, 95, 120, 46, 165, 159, 174, 167, 124, 176, 27, 90, 25, 89, 98, 114, 96, 70, 91, 132, 117, 49, 106, 121, 115, 29, 99, 154, 35, 15, 170, 83, 122, 10, 18, 12, 42, 13, 103, 39, 69, 114, 100, 61, 99, 76, 112, 117, 26, 72, 64, 108, 58, 175, 169, 179, 73, 67, 102, 106, 107, 139, 129, 86, 125, 174, 177, 52, 65, 101, 47, 57, 32, 82, 138, 77, 7, 84, 81, 75, 66, 22, 40, 28, 51, 30, 48, 29, 115, 46, 70, 60, 98, 45, 16, 79, 44, 43, 62, 56, 127, 31, 71, 55, 54, 126, 37, 111, 178, 128, 171, 78, 5, 6, 14, 19, 33, 49, 68, 3, 80, 38, 105, 123, 124, 173, 133, 121, 104, 135, 137, 132, 110, 11, 136, 131, 53, 50, 8, 24, 23, 41, 17, 74, 113, 97, 118, 134, 140, 176, 9, 20, 104, 120, 153, 79, 156, 184, 175, 71, 131, 145, 21, 23, 38, 22, 28, 40, 53, 43, 26, 45, 52, 2, 10, 27, 50, 44, 78, 9, 1, 47, 64, 73, 63, 76, 82, 49, 98, 140, 147, 166, 108, 107, 161, 39, 88, 95, 72, 83, 102, 134, 196, 214, 157, 146, 141, 143, 151, 228, 187, 125, 169, 159, 183, 186, 188, 195, 167, 182, 203, 222, 152, 202, 150, 208, 221, 211, 205, 178, 181, 201, 180, 199, 126, 90, 4, 46, 41, 30, 13, 16, 158, 162, 109, 8, 209, 67, 171, 193, 198, 54, 224, 226, 207, 135, 165, 174, 3, 7, 51, 81, 34, 25, 32, 33, 56, 192, 142, 144, 130, 80, 154, 155, 177, 215, 227, 223, 225, 210, 216, 217, 60, 160, 57, 149, 89, 173, 137, 179, 31, 59, 86, 93, 29, 68, 61, 124, 105, 103, 200, 194, 168, 204, 212, 206, 170, 189, 69, 218, 129, 37, 57, 95, 58, 62, 164, 128, 24, 42, 85, 122, 87, 100, 101, 99, 96, 138, 74, 97, 106, 65, 139, 219, 64, 38, 15, 14, 30, 17, 12, 20, 6, 8, 35, 56, 28, 29, 7, 72, 57, 3, 21, 1, 16, 75, 33, 58, 62, 22, 9, 25, 73, 31, 4, 5, 11, 67, 36, 37, 13, 34, 45, 23, 26, 66.

US Nationwide distribution.

Voluntary: Firm initiated