Use caution Medical device recall · FDA · Published November 4, 2024
Philips dS Breast 16ch 1.5T MRI Scanners: Potential Patient Harm During Scans
Philips recalls certain dS Breast 16ch 1.5T MRI scanners due to potential patient harm during scans. Affected units have specific serial numbers and reference codes listed in the recall notice.
Use caution until it’s fixed
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Contact the company
Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289
What happened, in plain English
Philips is recalling specific models of breast MRI scanners that could harm patients during scans. This recall is due to a potential safety issue that might cause injury during medical imaging procedures. Read more at govinfonow.com/recall/53577-philips-ds-breast-16ch-1-5t-mri-scanners-potential-patient.
Source Summary by GovInfoNow · govinfonow.com/recall/53577-philips-ds-breast-16ch-1-5t-mri-scanners-potential-patient · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0537-2025
Cite this page
“Philips dS Breast 16ch 1.5T MRI Scanners: Potential Patient Harm During Scans.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53577-philips-ds-breast-16ch-1-5t-mri-scanners-potential-patient. Based on FDA recall #Z-0537-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0537-2025%22&limit=1).
Why it’s dangerous
The scanner may cause harm to patients during preparation or the scan itself. This could happen if the device malfunctions during medical imaging procedures, potentially leading to injury.
Who’s affected
Patients undergoing breast MRI scans and healthcare providers using the recalled scanners are most at risk. The affected units are identified by specific serial numbers and reference codes.
How to tell if you have this one
Check the serial number or reference code on the scanner. Affected units have specific serial numbers listed in the recall notice, including numbers like 482, 508, 119, and others.
- Brand
Philips- Category
Medical device
All 13 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution.
| Recall number | Product, codes & lots |
|---|---|
| Z-0536-2025 | Achieva TX Interventional Coil 3.0T; REF: 453530264711; UDI: 00884838066175; Serial No. 171, 318, 274, 333, 116, 120, 169, 177, 449, 430, 280, 460, 301, 287, 539, 460, 545, 182, 301, 502, 533, 109, 194, 178, 240, 198, 197, 223, 209, 204, 224, 93, 212, 341, 303, 237, 282, 298, 309, 268, 281, 297, 296, 312, 313, 326, 323, 325, 327, 345, 340, 350, 320, 346, 459, 358, 420, 495, 496, 323, 509, 468, 467, 522, 553, 535, 546, 538, 497, 543, 320, 560, 544, 550, 581, 554, 558, 593, 580, 603, 582, 561, 605, 576, 606, 588, 618, 586, 587, 574, 624, 601, 608, 623, 607, 613, 627, 630, 631, 229, 498, 542, 534, 579, 469, 532, 145, 231, 328, 410, 195, 245, 98, 164, 135, 196, 234, 84, 583, 125, 238, 429, 510, 255, 294, 199, 61, 45, 131, 57, 134, 57, 134, 123, 147, 133, 210, 283, 324, 497, 524, 115, 150, 291, 277, 118, 310, 247, 67, 130, 279, 137, 202, 206, 220, 241, 124, 246, 106, 156, 286, 41, 132, 118, 151, 138, 113, 107, 119, 142, 180, 203, 230, 227, 254, 319, 321, 290, 322, 321, 507, 536, 528, 530, 578, 507, 332, 364, 508, 288, 83, 122, 579, 105, 144, 235, 110, 94, 213, 278, 470, 537, 541, 602, 626, 82, 165, 329. |
| Z-0537-2025 | dS Breast 16ch 1.5T; 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. |
| Z-0538-2025 | dS Breast 16ch 3.0T; 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. |
| Z-0539-2025 | dS Breast 7ch 1.5T; REF: 453530280881, 453530280882, 459801290431, 459801290432; UDI: 00884838066847, 00884838086111; Serial No. 507, 648, 409, 133, 596, 421, 613, 68, 121, 132, 757, 787, 622, 538, 687, 139, 357, 806, 838, 555, 615, 754, 813, 525, 70, 1755, 518, 594, 628, 662, 502, 653, 575, 629, 473, 281, 335, 367, 364, 567, 1672, 1683, 740, 144, 1673, 561, 1655, 445, 435, 1725, 1661, 823, 1720, 1736, 1711, 1788, 1774, 427, 584, 589, 616, 627, 618, 540, 472, 436, 583, 715, 812, 1713, 510, 1692, 400, 1681, 741, 119, 382, 1780, 641, 236, 184, 467, 830, 794, 712, 433, 450, 486, 520, 624, 574, 605, 755, 751, 827, 1700, 661, 714, 1706, 1740, 825, 190, 438, 29, 60, 72, 83, 128, 129, 198, 138, 154, 185, 191, 146, 283, 285, 362, 365, 300, 372, 323, 377, 666, 678, 535, 609, 683, 802, 781, 676, 1685, 795, 539, 610, 654, 1763, 1787, 790, 665, 681, 75, 122, 797, 1773, 422, 474, 453, 528, 550, 1739, 1734, 1718, 807, 837, 710, 1670, 734, 462, 482, 509, 579, 696, 348, 657, 829, 828, 836, 761, 818, 530, 634, 1674, 1735, 461, 526, 519, 562, 586, 593, 577, 645, 675, 658, 643, 670, 796, 744, 801, 1719, 800, 835, 1684, 1689, 1737, 1764, 1772, 735, 803, 1715, 388, 21, 90, 9, 2, 155, 109, 179, 197, 160, 172, 116, 169, 183, 194, 175, 201, 199, 286, 356, 391, 386, 387, 1771, 705, 1785, 1669, 1747, 778, 699, 644, 739, 644, 1680, 580, 651, 582, 604, 637, 603, 647, 667, 693, 732, 704, 749, 833, 792, 811, 1701, 429, 419, 438, 426, 453, 468, 487, 504, 524, 553, 573, 542, 548, 557, 558, 614, 576, 632, 625, 650, 652, 548, 728, 669, 698, 730, 700, 729, 711, 743, 799, 760, 1675, 1656, 1646, 1693, 1724, 1722, 1729, 1775, 747, 89, 95, 100, 106, 76, 20, 207, 114, 117, 159, 123, 200, 196, 209, 217, 212, 324, 343, 389, 358, 346, 378, 366, 381, 370, 399, 425, 394, 432, 430, 499, 551, 475, 663, 104, 148, 177, 158, 413, 411, 415, 455, 512, 1679, 566, 817, 779, 477, 789, 822, 1696, 152, 731, 67, 140, 349, 373, 690, 282, 464, 606, 585, 630, 816, 1697, 659, 396, 1, 30, 120, 166, 345, 375, 443, 488, 213, 597, 607, 638, 1782, 279, 815, 1647, 213, 590, 529, 1746, 655, 1784, 371, 390, 798, 777, 1648, 1691, 758, 1676, 1704, 736, 300, 533, 559, 588, 587, 118, 124, 186, 393, 416, 1702, 1742, 476, 523, 672, 1678, 1659, 1786, 824, 1738, 599, 454, 694, 1768, 668, 392, 398, 825, 1654, 819, 805, 1790, 531, 831, 1756, 460, 503, 554, 522, 552, 706, 791, 804, 1745, 1645, 161, 126, 137, 145, 189, 147, 410, 423, 545, 1690, 497, 689, 691, 1789, 458, 463, 569, 826, 1698, 620, 631, 125, 379, 572, 673, 1660, 397, 505, 1721, 1726, 110, 111, 176, 546, 543, 549, 578, 713, 437, 1705, 642, 1781, 446, 448, 660, 1770, 544, 418, 633, 188, 534, 440, 621, 613, 471, 501, 511, 679, 742, 688, 748, 793, 702, 820, 1712, 1748, 58, 112, 287, 374, 412, 780, 1714, 424, 466, 479, 485, 563, 556, 568, 677, 595, 611, 640, 656, 664, 646, 686, 703, 707, 750, 763, 709, 1677, 1682, 1738, 810, 762, 814, 692, 738, 759, 1703, 59, 484, 34, 42, 10, 88, 71, 18, 64, 43, 78, 103, 82, 98, 136, 152, 130, 135, 150, 119, 182, 151, 157, 187, 184, 180, 202, 192, 280, 153, 168, 241, 326, 208, 380, 327, 383, 368, 403, 384, 376, 385, 434, 420, 451, 470, 498, 532, 527, 536, 617, 764, 788, 1727, 1728, 1744, 113, 195, 363, 135, 565, 506, 591, 173, 165, 171, 3083, 3019, 3127, 3025, 3034, 3035, 3124, 3080, 3015, 3037, 3067, 3003, 3088, 3095, 3058, 3129, 3096, 3078, 3020, 3117, 3132, 3069, 3110, 3128, 3113, 3087, 3062, 3001, 3086, 3033, 3051, 3097, 3056, 3094, 825, 3054, 3125, 3106, 3116, 3036, 3052, 3030, 3005, 3105, 3131, 3104, 3090, 3137, 3134, 3118, 3021, 3091, 3041, 3061, 3068, 3046, 3018, 3009, 3010, 3042, 3055, 3060, 3011, 3040, 3065, 3047, 3053, 3098, 3130, 3139, 3112, 3108, 3063, 3059, 3032, 3007, 3103, 3061, 3089, 3023, 701, 3006, 3133, 1738, 3081, 3115, 3026, 3012, 3102, 3031, 3121, 3093, 3119, 3109, 3085, 3089, 3028, 3082, 3084, 3013, 3008, 3079, 3114, 3060, 3005, 3016, 3041, 3122, 3004, 3029, 3107, 3002, 3027, 195, 158, 357, 178, 334, 324, 85, 142, 318, 286, 149, 157, 128, 124, 176, 148, 195, 168, 96, 153, 131, 135, 141, 127, 163, 292, 134, 194, 193, 350, 254, 197, 81, 238, 291, 323, 199, 155, 267, 338, 317, 314, 354, 366, 378, 340, 25, 363, 121, 188, 336, 145, 360, 20, 3, 122, 183, 196, 234, 316, 329, 89, 70, 353, 118, 233, 231, 288, 247, 369, 21, 133, 130, 241, 356, 68, 119, 351, 320, 380, 190, 299, 69, 78, 94, 72, 285, 295, 297, 283, 365, 330, 160, 181, 266, 335, 185, 174, 298, 287, 319, 184, 284, 364, 250, 303, 200, 82, 227, 119, 165, 201, 328, 157, 229, 242, 248, 251, 156, 294, 246, 144, 231, 245, 186, 120, 99, 74, 90, 88, 123, 92, 151, 152, 162, 125, 166, 182, 345, 243, 249, 255, 265, 252, 342, 325, 331, 341, 300, 327, 307, 346, 377, 170, 304, 229, 348, 371, 236, 337, 259, 343, 306, 187, 164, 173, 22, 177, 310, 154, 370, 237, 313, 258, 83, 91, 305, 308, 355, 347, 321, 362, 257, 359, 67, 93, 349, 244, 253, 98, 235, 26, 2, 232, 1, 80, 75, 95, 66, 116, 169, 368, 161, 63, 230, 115, 64, 309, 147, 73, 114, 264, 150, 289, 296, 302, 367, 361, 379, 228, 261, 191, 315, 167, 143, 71, 86, 84, 179, 301, 293, 248, 326, 263, 311, 358, 352, 62, 146, 239, 262, 23, 79, 171, 256, 344, 312, 339, 1140, 1086, 1166, 1177, 1182, 1245, 1265, 1191, 1347, 1159, 1244, 1199, 1173, 1292, 1203, 1100, 1168, 1238, 1198, 1091, 1142, 1106, 1104, 1141, 1068, 1065, 1146, 1092, 1136, 1248, 1241, 1257, 1165, 1178, 1192, 1235, 1284, 1247, 1108, 1103, 1169, 1193, 1287, 1196, 1134, 1119, 1132, 1204, 1174, 1063, 1109, 1101, 1164, 1202, 1260, 1114, 1139, 1288, 1291, 1285, 1125, 1070, 1074, 1144, 1282, 1345, 1277, 1148, 1286, 1062, 1100, 1135, 1232, 1206, 1087, 1110, 1113, 1171, 1069, 1145, 1077, 1068, 1089, 1167, 1079, 1180, 1201, 1067, 1161, 1121, 1184, 1163, 1188, 1197, 1263, 1194, 1239, 1266, 1200, 1256, 1099, 1105, 1186, 1156, 1259, 1080, 1240, 1098, 1123, 1162, 1283, 1137, 1085, 1294, 1276, 1154, 1064, 1152, 1147, 1149, 1160, 1258, 1102, 1236, 1275, 1111, 1084, 1195, 1075, 1073, 1150, 1128, 1078, 1187, 1257, 1252, 1254, 1151, 1081, 1129, 1269, 1279, 1097, 1122, 1290, 1234, 1293, 1117, 1205, 1183, 1107, 1126, 1072, 1096, 1112, 1088, 1251, 1243, 1158, 1066, 1118, 1175, 1130, 1242, 1289, 1197, 1270, 1071, 1185, 1264, 1273, 1131, 1120, 1082, 1138, 1233, 1093, 1190, 1181, 1133, 1076, 1281, 1124, 1271, 1237, 1267, 1116, 1094, 1176, 1262, 1249, 1115, 1095, 1143, 1189, 1090, 1155. |
| Z-0540-2025 | dS Breast 7ch 3.0T; REF: 453530280891, 453530280892, 459801290711, 459801290712, 459801729911, 459801729911, 459801729912, 459801729913; UDI-DI: 00884838066168, 00884838086173, 00884838098404, 00884838107953, 00884838118294; Serial No. 1050, 632, 709, 981, 944, 1060, 175, 703, 723, 1009, 102, 209, 227, 365, 514, 342, 509, 742, 753, 801, 819, 1013, 462, 903, 912, 833, 868, 843, 884, 892, 1002, 1038, 182, 170, 946, 980, 747, 219, 626, 907, 827, 840, 861, 854, 890, 871, 860, 850, 878, 891, 859, 894, 883, 889, 926, 863, 880, 909, 910, 988, 904, 888, 902, 966, 913, 929, 998, 935, 896, 928, 932, 943, 959, 958, 1051, 1041, 972, 1011, 982, 997, 978, 991, 992, 995, 987, 1062, 1008, 1004, 747, 999, 1029, 1044, 1014, 1063, 1036, 1057, 1058, 220, 297, 337, 339, 343, 543, 545, 615, 607, 602, 685, 623, 635, 619, 670, 496, 633, 229, 614, 628, 642, 624, 680, 717, 644, 676, 705, 682, 707, 792, 697, 776, 727, 704, 715, 713, 757, 805, 731, 770, 803, 754, 775, 778, 756, 751, 768, 689, 761, 794, 793, 799, 779, 773, 815, 814, 930, 990, 938, 205, 893, 1061, 858, 609, 538, 767, 135, 127, 977, 812, 893, 879, 692, 22, 617, 816, 832, 877, 51, 82, 93, 66, 103, 223, 148, 239, 234, 421, 612, 422, 232, 1000, 168, 106, 798, 117, 744, 876, 925, 927, 684, 810, 864, 874, 1030, 985, 677, 746, 169, 83, 146, 190, 145, 211, 208, 212, 230, 241, 235, 567, 618, 608, 802, 898, 866, 165, 181, 688, 1027, 215, 763, 905, 911, 882, 706, 640, 745, 811, 808, 837, 836, 849, 844, 856, 867, 881, 931, 924, 960, 948, 968, 983, 1010, 620, 622, 625, 396, 630, 612, 681, 696, 636, 643, 684, 687, 725, 726, 720, 741, 743, 797, 831, 809, 824, 847, 855, 899, 865, 852, 934, 895, 906, 897, 964, 965, 845, 1043, 1033, 1042, 85, 139, 177, 149, 185, 253, 147, 118, 172, 226, 206, 184, 238, 195, 228, 218, 221, 240, 194, 342, 497, 60, 302, 260, 244, 261, 254, 512, 293, 341, 600, 460, 583, 423, 509, 616, 627, 526, 764, 77, 461, 679, 551, 237, 845, 1040, 139, 171, 139, 171, 701, 846, 885, 698, 777, 144, 236, 188, 213, 310, 634, 700, 691, 971, 718, 61, 996, 183, 233, 817, 368, 647, 686, 848, 1059, 258, 510, 396, 732, 78, 842, 791, 821, 933, 962, 969, 1006, 749, 869, 936, 176, 367, 172, 886, 719, 804, 857, 949, 728, 975, 695, 830, 527, 825, 908, 631, 699, 716, 721, 774, 755, 796, 826, 823, 841, 961, 951, 920, 1045, 1001, 1012, 1047, 993, 47, 9, 189, 124, 338, 366, 550, 542, 552, 581, 224, 1028, 750, 772, 1053, 820, 851, 1003, 166, 340, 629, 722, 862, 989, 795, 994, 52, 511, 613, 937, 683, 639, 710, 689, 730, 614, 887, 967, 957, 1034, 17, 58, 36, 59, 8, 116, 99, 81, 151, 92, 91, 126, 101, 79, 128, 150, 125, 23, 167, 210, 152, 207, 229, 217, 216, 242, 222, 243, 380, 496, 426, 526, 195, 541, 252, 637, 769, 71, 2052, 2075, 2073, 2095, 2032, 2086, 2011, 2019, 2070, 2102, 2074, 2010, 2041, 2021, 2088, 2013, 2025, 2098, 2042, 2024, 2046, 2017, 2063, 2050, 2087, 2106, 2062, 2097, 2047, 2072, 2085, 2071, 2037, 2058, 2084, 2093, 2069, 2108, 2099, 2103, 2091, 2083, 2027, 2107, 2051, 2100, 2035, 2043, 2105, 2023, 2034, 2036, 2043, 2061, 2110, 2038, 2040, 2048, 2016, 2022, 2049, 2039, 2059, 2030, 2045, 2033, 2031, 2060, 2064, 2076, 2051, 2037, 2028, 2018, 2094, 2068, 2030, 2014, 2012, 2112, 2053, 2015, 2090, 2026, 2044, 2096, 2109, 251, 17, 210, 44, 66, 108, 155, 55, 40, 119, 98, 128, 69, 112, 233, 113, 139, 100, 185, 137, 171, 170, 159, 183, 223, 181, 247, 235, 201, 240, 264, 256, 241, 222, 70, 56, 68, 16, 199, 118, 105, 75, 83, 10, 103, 63, 76, 73, 65, 85, 50, 254, 135, 121, 61, 34, 84, 79, 62, 80, 46, 64, 77, 158, 86, 95, 120, 74, 109, 114, 132, 111, 81, 97, 64, 164, 140, 131, 143, 165, 187, 163, 192, 173, 200, 184, 177, 190, 206, 172, 232, 194, 209, 208, 198, 220, 255, 228, 253, 213, 231, 248, 217, 239, 195, 246, 238, 268, 122, 138, 175, 263, 37, 13, 41, 160, 87, 218, 156, 205, 234, 244, 250, 204, 245, 58, 265, 154, 211, 227, 96, 54, 267, 92, 266, 99, 35, 82, 49, 90, 142, 133, 225, 257, 230, 30, 38, 32, 104, 110, 117, 157, 116, 124, 134, 229, 237, 219, 93, 51, 174, 102, 221, 33, 261, 48, 216, 243, 207, 60, 176, 161, 249, 59, 115, 67, 91, 101, 178, 188, 182, 191, 214, 242, 236, 36, 180, 127, 224, 123, 94, 31, 45, 260, 125, 130, 169, 258, 162, 252, 144, 186, 166, 47, 226, 203, 42, 57, 202, 215, 89, 129, 167, 179, 1123, 1159, 1119, 1312, 1308, 1136, 1128, 1115, 1060, 1162, 1086, 1169, 1007, 1084, 1088, 1054, 1087, 1083, 1062, 1075, 1076, 1116, 1192, 1104, 1132, 1168, 1180, 1152, 1153, 1107, 1331, 1307, 1135, 1196, 1324, 1268, 1340, 1008, 1052, 1318, 1271, 1056, 1130, 1096, 1080, 1089, 1059, 1077, 1066, 1064, 1078, 1103, 1057, 1055, 1079, 1091, 1092, 1102, 1163, 1141, 1114, 1148, 1134, 1097, 1109, 1120, 1099, 1110, 1183, 1131, 1094, 1137, 1154, 1195, 1184, 1188, 1158, 1178, 1138, 1122, 1175, 1274, 1108, 1142, 1164, 1149, 1150, 1182, 1215, 1176, 1179, 1277, 1121, 1266, 1337, 1272, 1173, 1214, 1310, 1267, 1265, 1144, 1216, 1270, 1275, 1325, 1327, 1334, 1350, 1311, 1349, 1069, 1022, 1273, 1317, 1146, 1278, 1185, 1269, 1316, 1345, 1342, 1280, 1157, 1061, 1329, 1309, 1347, 1170, 1151, 1070, 1098, 1143, 1320, 1187, 1140, 1071, 1095, 1106, 1127, 1058, 1166, 1124, 1313, 1161, 1165, 1217, 1186, 1346, 1326, 1343, 1197, 1065, 1156, 1139, 1118, 1081, 1145, 1174, 1323, 1262, 1171, 1085, 1073, 1067, 1105, 1330, 1193, 1315, 1172, 1167, 1101, 1090, 1341, 1314, 1126, 1053, 1322, 1063, 1111, 1133, 1117, 1072, 1125, 1279, 1321, 1335, 1068, 1129, 1280, 1332, 1107, 1333, 1264, 1328, 1348, 1264, 1093, 27, 52, 29, 98, 25, 48, 44, 71, 65, 132, 20, 49, 81, 61, 5, 146, 43, 8, 47, 26, 78, 143, 32, 13, 137, 57, 34, 38, 30, 11, 39, 50, 46, 140, 181, 122, 58, 68, 74, 142, 76, 123, 101, 111, 125, 186, 97, 105, 165, 169, 172, 138, 147, 148, 150, 180, 168, 154, 176, 187, 188, 163, 19, 28, 23, 141, 18, 51, 63, 56, 107, 67, 106, 89, 99, 144, 170, 184, 164, 160, 124, 21, 55, 93, 158, 91, 85, 84, 109, 139, 133, 103, 127, 117, 136, 112, 182, 62, 54, 171, 24, 9, 31, 45, 69, 190, 4, 131, 178, 70, 102, 128, 36, 60, 83, 151, 96, 121, 108, 80, 72, 104, 110, 183, 173, 135, 82, 166, 119, 77, 95, 152, 159, 189, 14, 41, 59, 66, 120, 145, 174, 7, 162, 6, 17, 130, 88, 2, 35, 177, 185, 1, 179, 64, 175, 92, 33, 134, 162, 40, 10, 16, 22, 42, 94, 149, 87, 153, 161, 15, 29, 139, 101, 19, 12, 17, 4, 10, 8, 71, 53, 109, 103, 69, 7, 25, 96, 50, 6, 15, 77, 47, 64, 28, 70, 73, 132, 168, 163, 126, 121, 180, 62, 39, 68, 26, 95, 49, 48, 89, 162, 165, 157, 100, 128, 145, 93, 87, 160, 142, 94, 107, 136, 177, 83, 21, 80, 105, 36, 79, 148, 13, 129, 114, 110, 138, 78, 173, 135, 119, 86, 159, 90, 127, 118, 14, 56, 99, 32, 175, 104, 72, 88, 5, 164, 146, 131, 111, 82, 155, 181, 167, 143, 174, 123, 20, 166, 133, 179, 125, 149, 169, 140, 27, 23, 150, 60, 74, 153, 76, 59, 1, 113, 158, 33, 182, 124, 18, 151, 106, 85, 130, 170, 172, 52, 134, 98, 55, 102, 171, 147, 92, 16, 108, 141, 115, 176, 137, 144, 54, 75, 9, 2, 34, 42, 30, 40, 37, 178, 66, 35, 156, 11, 3, 152, 120, 112, 61, 76, 24, 20, 41, 39, 22, 30, 35, 2, 18, 17, 38, 43, 23, 37, 72, 11, 65, 40. |
| Z-0541-2025 | Mammotrak Diagnostic Coil 1.5T; REF: 453530228872; UDI-DI: 00884838066762; Serial No. 79, 124, 71, 179, 124, 182, 45, 43, 178, 171, 181, 53, 40, 52, 69, 187, 95. |
| Z-0542-2025 | Mammotrak Interventional Coil 1.5T; REF: 453530228882; UDI-DI: 00884838066779; Serial No. 69, 82, 143, 64, 77, 87, 76, 81, 134, 124, 141, 103, 135, 138, 73, 72, 131. |
| Z-0543-2025 | Mammotrak Diagnostic Coil 3.0T; REF: 453530228911; UDI-DI: 00884838066786; Serial No. 91, 130, 80, 53, 90, 11, 58, 25, 51, 4, 67, 34. |
| Z-0544-2025 | Mammotrak Interventional Coil 3.0T; REF: 453530228891; UDI-DI: 00884838065857; Serial No. 73, 96, 58, 95, 119, 26, 16, 56, 94, 38, 28, 66, 135, 120, 2, 76. |
| Z-0545-2025 | SENSE Breast Coil; REF: 453530083951; UDI-DI: 00884838066588; Serial No. 36987, 36587, 36690, 36898, 37009, 36637, 37129, 37140, 36957, 36549, 36548, 36547, 36893, 36678, 36736, 36743, 36744, 36763, 36770, 36882, 36897, 36938, 36939, 37012, 36585, 36622, 36618, 36639, 36635, 36650, 36648, 36732, 36681, 36676, 36769, 36861, 36885, 36878, 36883, 36890, 36894, 36950, 36941, 36994, 37000, 36998, 36993, 37130, 37159, 37160, 36874, 37032, 37053, 37208, 37127, 37148, 37151, 37143, 36559, 37007, 37141, 36544, 36552, 36580, 36557, 36564, 36630, 36738, 36754, 36762, 36768, 36592, 36603, 36632, 36629, 36673, 36626, 36667, 36660, 36671, 36653, 36691, 36737, 36740, 36749, 36735, 36750, 36747, 36771, 36796, 36803, 36798, 36802, 36794, 36812, 36842, 36741, 36847, 36930, 36865, 36860, 36864, 36867, 36877, 36853, 36884, 36876, 36919, 36880, 36896, 36901, 36891, 36963, 36933, 36899, 36908, 36913, 36907, 36912, 36915, 36983, 36972, 36929, 36931, 36935, 36928, 36927, 36943, 36932, 36942, 36992, 36945, 36940, 36948, 36955, 36949, 37003, 36954, 36953, 36956, 36967, 36966, 36962, 36989, 37004, 37006, 37022, 36974, 37043, 37015, 37020, 37001, 37005, 37014, 37018, 37038, 37072, 37010, 37011, 37026, 37024, 37017, 37019, 37021, 37028, 36988, 37025, 37051, 37055, 37084, 37031, 37029, 37070, 37036, 37042, 37052, 37071, 37056, 37034, 37074, 37092, 37041, 37080, 37079, 37095, 37090, 37118, 37133, 37125, 37085, 37124, 37142, 37122, 37150, 37163, 37139, 37147, 37137, 37176, 37173, 37157, 37155, 37152, 37161, 37179, 37164, 37162, 37191, 37181, 37182, 37188, 37243, 37226, 37190, 37192, 37206, 37195, 37207, 37238, 37214, 37222, 37225, 37234, 37264, 36662, 37280, 36581, 36910, 37040, 37016, 37128, 37138, 37165, 36873, 36996, 36606, 36920, 37169, 37268, 37265, 36553, 36652, 36797, 36905, 37282, 37283, 36947, 37167, 36633, 36624, 37136, 36565, 36636, 36644, 36661, 36654, 36602, 36730, 36758, 36815, 36839, 36862, 36888, 36895, 36926, 36997, 36991, 36985, 37008, 37078, 37126, 37154, 37178, 37174, 37184, 37193, 37186, 37199, 37185, 37189, 37175, 37273, 37242, 37272, 37267, 37224, 37119, 37131, 37123, 37153, 37166, 37200, 37210, 37196, 37223, 37211, 37239, 37266, 36655, 37044, 37039, 36801, 36809, 36537, 36576, 36556, 36568, 36535, 36666, 36674, 37281, 37083, 37076, 37114, 36863, 36811, 37097, 36871, 36575, 36599, 36638, 36600, 36649, 37054, 36566, 36806, 36808, 37096, 36545, 36623, 37121, 36795, 36608, 36611, 36964, 36973, 36669, 36586, 36583, 36904, 36569, 36960, 36921, 36923, 36936, 36951, 37035, 36946, 37177, 37221, 36846, 36625, 36677, 36817, 36870, 36748, 36563, 36539, 36698, 36664, 36686, 36810, 36914, 37183, 36577, 37073, 36656, 36813, 36909, 36906. |
| Z-0546-2025 | SENSE Breast Coil 3.0T 7ch; REF: 453530089302; UDI-DI: 00884838065413; Serial No. 16, 7, 22, 52. |
| Z-0547-2025 | ST SENSE Breast Coil; REF: 453530054571; UDI-DI: 00884838066625; Serial No. 36577, 36597, 36664, 36706, 36540, 36604, 36590, 36670, 36671, 36704, 36710, 36712, 36524, 36555, 36519, 36521, 36570, 36573, 36582, 36580, 36581, 36603, 36619, 36663, 36680, 36711, 36548, 36576, 36589, 36606, 36523, 36567, 36572, 36601, 36639, 36661, 36536, 36588, 36635, 36631, 36668, 36613, 36677, 36530, 36556, 36661, 36575, 36592, 36632, 36657, 36669, 36602, 36674, 36703, 36534, 36551, 36541, 36549, 36547, 36525, 36526, 36528, 36574, 36571, 36595, 36614, 36605, 36600, 36636, 36634, 36662, 36641. |
| Z-0548-2025 | ST SENSE Breast Dx Coil; REF: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54. |
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Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 30 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0537-2025 (November 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0537-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
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