FDAFDA · Food and drugs·Recall number Z-0537-2025
dS Breast 16ch 1.5T
Published December 4, 2024 · Recall initiated: November 4, 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 safety issue where a patient may be harmed while preparing for or during a scan.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America Llc
- Distributor
- US Nationwide distribution.
- Lot
- REF: 453530280721, 453530280723, 459801290511, 459801290514, 459801729882; UDI: 00884838066854, 00884838086425, 00884838118393; Serial No. 482, 508, 119, 40, 318, 394, 443, 41, 286, 120, 264, 412, 426, 457, 476, 342, 154, 319, 368, 409, 176, 35, 265, 416, 392, 437, 493, 529, 500, 526, 517, 531, 533, 276, 430, 509, 333, 356, 370, 445, 510, 53, 125, 117, 268, 174, 175, 282, 310, 452, 425, 399, 389, 442, 442, 303, 505, 45, 375, 369, 321, 325, 347, 300, 377, 372, 423, 448, 470, 525, 413, 458, 385, 510, 387, 314, 327, 335, 340, 376, 447, 401, 410, 486, 487, 507, 515, 516, 2, 129, 124, 122, 264, 272, 284, 304, 311, 479, 514, 344, 349, 513, 453, 367, 512, 513, 309, 306, 313, 355, 362, 363, 406, 390, 444, 428, 451, 488, 523, 504, 532, 444, 528, 52, 27, 146, 301, 315, 281, 520, 114, 424, 336, 535, 155, 411, 449, 524, 433, 25, 128, 137, 123, 144, 300, 158, 274, 300, 302, 307, 446, 308, 160, 275, 46, 329, 359, 353, 115, 138, 348, 534, 478, 502, 358, 431, 149, 383, 354, 351, 346, 454, 527, 271, 326, 339, 371, 386, 497, 391, 435, 163, 283, 332, 405, 159, 269, 352, 459, 456, 496, 501, 330, 388, 530, 113, 148, 157, 156, 320, 176, 415, 384, 407, 145, 10, 2, 71, 54, 12, 112, 118, 64, 102, 151, 147, 150, 153, 146, 166, 273, 267, 280, 1081, 1071, 1098, 1097, 1024, 1000, 1050, 1047, 1003, 1074, 528, 1069, 1096, 1052, 510, 1072, 1088, 1030, 1089, 1070, 1073, 1087, 1085, 1001, 1017, 1082, 513, 1005, 1022, 1051, 1093, 1103, 1104, 1090, 1032, 1083, 1076, 1063, 1062, 1075, 1067, 1004, 1006, 1091, 1080, 1068, 1046, 31, 120, 109, 106, 111, 3, 112, 7, 60, 122, 34, 139, 51, 43, 72, 38, 88, 104, 35, 105, 114, 62, 133, 138, 28, 37, 151, 74, 56, 108, 113, 55, 36, 18, 115, 4, 152, 24, 40, 21, 39, 23, 85, 150, 27, 15, 69, 65, 103, 153, 86, 61, 64, 42, 38, 58, 71, 1, 41, 117, 4, 6, 16, 47, 46, 29, 87, 127, 75, 107, 110, 68, 136, 5, 9, 8, 89, 118, 45, 149, 137, 2, 52, 67, 124, 119, 32, 71, 19, 66, 53, 73, 150, 13, 126, 132, 20, 121, 90, 125, 131, 11, 63, 48, 17, 123, 10, 148, 147, 57, 30, 33, 44, 54, 70, 81, 39, 32, 95, 42, 33, 55, 132, 40, 36, 111, 48, 49, 76, 108, 50, 22, 115, 119, 66, 35, 24, 20, 18, 34, 16, 102, 128, 51, 14, 83, 65, 74, 82, 120, 125, 129, 110, 59, 12, 71, 11, 28, 54, 172, 104, 67, 21, 29, 46, 58, 41, 78, 89, 26, 44, 80, 116, 64, 70, 45, 114, 118, 130, 27, 63, 15, 17, 109, 72, 103, 126, 171, 168, 23, 56, 100, 9, 37, 57, 25, 30, 53, 113, 173, 99, 75, 86, 69, 121, 31, 106, 73, 94, 6, 174, 68, 77, 88, 170, 10, 60, 13, 19, 52, 47, 112, 98, 117, 105, 61, 123, 167, 2, 33, 29, 30, 36, 20, 18, 12, 17, 7, 39, 5, 3, 35, 4, 13, 32, 28, 10, 23, 45.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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