FDA event 95645 · Recall Observatory

device · product 1 of 13

Achieva TX Interventional Coil 3.0T

Z-0536-2025

Recall number: Z-0536-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide distribution.

device · product 2 of 13

dS Breast 16ch 1.5T

Z-0537-2025

Recall number: Z-0537-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide distribution.

device · product 3 of 13

dS Breast 16ch 3.0T

Z-0538-2025

Recall number: Z-0538-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide distribution.

device · product 4 of 13

dS Breast 7ch 1.5T

Z-0539-2025

Recall number: Z-0539-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide distribution.

device · product 5 of 13

dS Breast 7ch 3.0T

Z-0540-2025

Recall number: Z-0540-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide distribution.

device · product 6 of 13

Mammotrak Diagnostic Coil 1.5T

Z-0541-2025

Recall number: Z-0541-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF: 453530228872; UDI-DI: 00884838066762; Serial No. 79, 124, 71, 179, 124, 182, 45, 43, 178, 171, 181, 53, 40, 52, 69, 187, 95.

Distribution pattern

US Nationwide distribution.

device · product 7 of 13

Mammotrak Interventional Coil 1.5T

Z-0542-2025

Recall number: Z-0542-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF: 453530228882; UDI-DI: 00884838066779; Serial No. 69, 82, 143, 64, 77, 87, 76, 81, 134, 124, 141, 103, 135, 138, 73, 72, 131.

Distribution pattern

US Nationwide distribution.

device · product 8 of 13

Mammotrak Diagnostic Coil 3.0T

Z-0543-2025

Recall number: Z-0543-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF: 453530228911; UDI-DI: 00884838066786; Serial No. 91, 130, 80, 53, 90, 11, 58, 25, 51, 4, 67, 34.

Distribution pattern

US Nationwide distribution.

device · product 9 of 13

Mammotrak Interventional Coil 3.0T

Z-0544-2025

Recall number: Z-0544-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF: 453530228891; UDI-DI: 00884838065857; Serial No. 73, 96, 58, 95, 119, 26, 16, 56, 94, 38, 28, 66, 135, 120, 2, 76.

Distribution pattern

US Nationwide distribution.

device · product 10 of 13

SENSE Breast Coil

Z-0545-2025

Recall number: Z-0545-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide distribution.

device · product 11 of 13

SENSE Breast Coil 3.0T 7ch

Z-0546-2025

Recall number: Z-0546-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF: 453530089302; UDI-DI: 00884838065413; Serial No. 16, 7, 22, 52.

Distribution pattern

US Nationwide distribution.

device · product 12 of 13

ST SENSE Breast Coil

Z-0547-2025

Recall number: Z-0547-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US Nationwide distribution.

device · product 13 of 13

ST SENSE Breast Dx Coil

Z-0548-2025

Recall number: Z-0548-2025
Initiated: November 04, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Philips North America Llc
Quantity: 5,231 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

REF: 453530264791; UDI-DI: 00884838066823; Serial No. 55, 3, 9, 36, 40, 56, 35, 39, 80, 46, 29, 7, 28, 55, 47, 54.

Distribution pattern

US Nationwide distribution.

Event summary

Source snapshots represented here

Every recalled product in this event

Reason for recall

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