🔍 RecallPedia

dS Breast 16ch 1.5T

Class I - Dangerous
🏥 Medical Devices Recalled: November 4, 2024 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America Llc
Reason for Recall:
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

dS Breast 16ch 1.5T

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0537-2025

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