Philips North America Llc recalls dS Breast 16ch 1.5T

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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.