🔍 RecallPedia

dS Breast 7ch 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: 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.
  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 7ch 1.5T

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0539-2025

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