Philips North America Llc Recall 95645
Description: dS Breast 16ch 1.5T
Philips North America Llc Recall 95645 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0537-2025 |
| Event ID | 95645 |
| Event Description | dS Breast 16ch 1.5T |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 5,231 units |
| Recall Reason | Potential safety issue where a patient may be harmed while preparing for or during a scan. |
| Device Classification | 20241204 |
| Device 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. |
| Center Classification Date | 20241125 |
| Recall Initiation Date | 20241104 |
| Recalling Firm | Philips North America Llc |
| Initial Notification | Letter |
| Similar To |