BEUDAMED
    FDA Enforcement Class II Ongoing

    dS Breast 16ch 3.0T

    Recall: Z-0538-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0538-2025
    Event ID
    95645
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    November 4, 2024
    Classification Date
    November 25, 2024
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    Description

    dS Breast 16ch 3.0T

    Reason

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

    Code Info

    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.

    Distribution

    US Nationwide distribution.

    Quantity

    5,231 units