CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

dS Breast 7ch 5T recalled by Philips North America

Philips North America is recalling dS Breast 7ch 5T, distributed nationwide in the US. The recall was initiated on 4 Nov 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF: 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.

Quantity recalled5,231 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0539-2025
FDA event ID: 95645
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Nov 2024
FDA classified: 25 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Nov 2024	Recall initiated by company
25 Nov 2024	Classified by FDA	+21 days
4 Dec 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

dS Breast 7ch 1.5T

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is dS Breast 7ch 5T recalled?

Yes. Philips North America recalled dS Breast 7ch 5T on 4 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0539-2025.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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