PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3)

Hazard / Issue

Possibility of the patient falling from the table related to the mattress used on the patient table.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Catalog numbers: (1) 722068, (2) 722226, (3) 722236; UDI-DI: (1) 00884838085367, (2) 00884838099272, (3) 00884838116801; Serial Numbers: (1) 213, 407, 85, 89, 320, 73, 308, 288, 172, 295, 110, 406, 4444, 149, 350, 243, 143, 146, 109, 413, 137, 335, 270, 319, 95, 322, 324, 374, 170, 440, 184, 64, 373, 442, 431, 136, 279, 75, 251, 400, 271, 337, 329, 232, 261, 262, 477, 564, 354, 361, 443, 104, 114, 82, 490, 196, 370, 84, 107, 528, 247, 205, 42, 117, 469, 103, 520, 446, 78, 304, 153, 323, 457, 470, 472, 150, 277, 147, 547, 462, 479, 511, 285, 487, 101, 524, 282, 76, 510, 130, 356, 494, 178, 467, 505, 239, 225, 459, 265, 275, 485, 549, 534, 365, 314, 481, 77, 552, 44, 62, 158, 535, 453, 338, 399, 215, 37, 360, 36, 408, 420, 276, 68, 359, 584, 608, 563, 556, 557, 597, 601, 605, 553, 551, 516, 612, 614, 590, 540, 591, 617, 616, 599, 602, 570, 618, 574, 560, 609, 526, 559, 603, 600, 575, 593, 589, 624, 604, 372, 212, 475, 142, 97, 236, 237, 87, 53, 376, 111, 74, 394, 138, 185, 515, 162, 79, 35, 347, 134, 254, 416, 242, 219, 47, 250, 336, 299, 127, 145, 398, 471, 531, 290, 533, 198, 422, 380, 532, 168, 140, 483, 484, 228, 478, 460, 211, 468, 125, 102, 268, 269, 414, 543, 466, 105, 208, 106, 217, 263, 507, 202, 154, 273, 264, 175, 501, 144, 465, 315, 502, 188, 252, 379, 439, 298, 436, 278, 135, 391, 390, 200, 201, 224, 187, 404, 311, 498, 183, 296, 430, 139, 94, 156, 122, 197, 300, 98, 393, 132, 112, 63, 163, 45, 116, 189, 66, 90, 253, 274, 260, 368, 367, 191, 152, 331, 161, 67, 464, 503, 451, 226, 409, 155, 248, 61, 108, 297, 281, 128, 129, 318, 423, 518, 527, 506, 415, 521, 529, 417, 432, 292, 362, 246, 438, 497, 328, 450, 181, 173, 233, 289, 234, 326, 509, 519, 148, 568, 238, 583, 491, 536, 240, 69, 60, 283, 227, 396, 286, 349, 204, 230, 447, 334, 174, 49, 397, 83, 291, 448, 426, 427, 317, 571, 199, 500, 210, 192, 166, 293, 387, 258, 72, 118, 257, 133, 425, 206, 180, 327, 339, 179, 182, 306, 382, 160, 244, 115, 48, 93, 473, 537, 548, 550, 495, 369, 480, 577, 539, 303, 302, 207, 96, 280, 231, 364, 301, 454, 88, 325, 167, 445, 428, 316, 434, 435, 489, 555, 544, 562, 522, 313, 71, 346, 50, 141, 124, 508, 410 ****Serial Numbers Added 5/2/2025**** 444, 195; (2) 219, 469, 473, 464, 254, 845, 272, 912, 105, 323, 239, 144, 266, 891, 398, 319, 339, 182, 116, 559, 391, 534, 107, 680, 204, 675, 255, 153, 350, 442, 681, 690, 691, 260, 325, 688, 280, 180, 318, 702, 313, 468, 463, 761, 392, 400, 139, 158, 183, 78, 374, 427, 205, 482, 592, 593, 462, 121, 467, 220, 381, 19, 326, 100, 823, 213, 214, 215, 410, 508, 678, 545, 143, 724, 337, 360, 75, 1008, 181, 842, 555, 11, 244, 793, 189, 190, 380, 98, 343, 757, 955, 341, 1021, 208, 59, 361, 971, 114, 362, 129, 197, 174, 687, 281, 117, 554, 270, 918, 147, 113, 848, 756, 758, 108, 981, 379, 441, 446, 173, 271, 921, 495, 159, 778, 779, 383, 419, 472, 894, 689, 120, 122, 123, 124, 125, 126, 127, 332, 782, 876, 301, 262, 1002, 403, 67, 112, 175, 871, 294, 269, 704, 149, 194, 249, 432, 870, 142, 892, 321, 87, 790, 1, 261, 679, 141, 766, 514, 744, 798, 1023, 900, 901, 553, 747, 903, 670, 717, 907, 544, 886, 943, 745, 941, 527, 815, 799, 800, 963, 549, 663, 662, 669, 965, 697, 671, 674, 579, 603, 604, 830, 938, 939, 740, 888, 617, 979, 621, 1065, 902, 820, 887, 716, 665, 577, 748, 739, 672, 825, 736, 949, 860, 877, 751, 737, 813, 648, 632, 1061, 539, 228, 368, 950, 489, 622, 896, 27, 14, 749, 546, 552, 548, 367, 366, 289, 359, 131, 16, 423, 874, 243, 60, 176, 677, 880, 628, 637, 685, 491, 25, 345, 349, 6, 29, 625, 93, 457, 140, 63, 238, 299, 385, 166, 364, 84, 5, 506, 772, 320, 355, 557, 227, 305, 188, 827, 453, 650, 883, 171, 26, 889, 833, 282, 574, 956, 913, 585, 531, 905, 822, 477, 417, 754, 684, 509, 297, 342, 1009, 972, 83, 945, 743, 755, 924, 817, 791, 589, 726, 720, 399, 460, 503, 1014, 1015, 777, 831, 431, 481, 486, 274, 1041, 245, 298, 1049, 395, 230, 523, 686, 259, 520, 521, 522, 993, 708, 738, 878, 86, 890, 50, 664, 85, 768, 7, 333, 405, 287, 382, 433, 229, 568, 500, 34, 336, 106, 541, 56, 196, 236, 567, 659, 770, 694, 841, 308, 70, 537, 421, 570, 819, 30, 668, 241, 79, 92, 73, 353, 811, 722, 160, 80, 436, 529, 90, 302, 273, 74, 137, 454, 187, 402, 479, 42, 290, 866, 496, 588, 375, 587, 452, 210, 71, 524, 95, 269, 934, 69, 502, 581, 172, 32, 476, 288, 807, 77, 317, 606, 928, 847, 803, 560, 28, 33, 38, 192, 193, 35, 304, 804, 146, 857, 163, 115, 646, 660, 406, 908, 234, 312, 110, 340, 806, 91, 89, 44, 65, 578, 784, 450, 128, 904, 40, 801, 802, 525, 285, 653, 49, 852, 62, 556, 43, 161, 39, 856, 853, 851, 265, 206, 258, 656, 154, 356, 41, 155, 157, 863, 652, 855, 657, 499, 916, 583, 240, 165, 324, 1032, 933, 440, 237, 257, 425, 654, 709, 46, 162, 655, 358, 540, 156, 31, 279, 818, 68, 96, 658, 885, 286, 216, 456, 186, 357, 177, 619, 64, 998, 292, 828, 528, 558, 264, 404, 451, 838, 283, 284, 401, 530, 967, 478, 199, 152, 201, 202, 303, 666, 1006, 771, 580, 645, 995, 195, 599, 676, 595, 424, 586, 696, 409, 947, 605, 420, 449, 226, 752, 184, 978, 393, 198, 946, 627, 765, 647, 895, 413, 682, 789, 17, 422, 596, 741, 275, 235, 573, 251, 533, 727, 846, 1035, 225, 630, 164, 667, 733, 458, 742, 4, 439, 118, 217, 418, 203, 808, 263, 429, 148, 384, 809, 369, 82, 10, 330, 24, 598, 231, 224, 233, 88, 840, 407, 844, 649, 753, 673, 276, 438, 444, 119, 1026, 412, 715, 732, 411, 953, 958, 513, 725, 623, 731, 21, 992, 762, 882, 824, 826, 45, 505, 168, 542, 507, 66, 396, 497, 485, 490, 494, 643, 644, 543, 351, 636, 849, 633, 634, 504, 97, 550, 551, 484, 631, 316, 639, 640, 547, 448, 642, 563, 591, 52, 53, 22, 277, 278, 207, 835, 836, 773, 331, 982, 1000, 1013, 832, 501, 327, 775, 810, 698, 575, 576, 1046, 386, 764, 430, 1033, 795, 927, 1018, 997, 785, 861, 487, 584, 1050, 626, 363, 480, 498, 721, 919, 693, 712, 510, 898, 869, 984, 306, 561, 378, 221, 222, 829, 899, 232, 344, 61, 701, 415, 711, 18, 352, 47, 435, 307, 36, 641, 714, 1048, 515, 957, 178, 179, 250, 867, 872, 710, 974, 99, 247, 54, 692, 408, 906, 455, 132, 133, 416, 314 ****Serial Numbers Added 5/2/2025**** 969, 970, 973, 1007, 1017, 1052, 3; (3) 32, 20, 17, 26, 39, 46, 8, 34, 29, 10, 27, 41, 53, 49, 33, 23 ****Serial Numbers Added 5/2/2025**** 21, 22, 24, 25, 36, 40, 42, 54, 68, 116, 118, 194, 13, 30, 44, 52, 56, 59, 62, 63, 64, 66, 67, 69, 70, 73, 74, 75, 76, 80, 82, 83, 84, 85, 86, 88, 89, 90, 91, 92, 93, 94, 96, 98, 100, 102, 104, 105, 106, 108, 111, 112, 113, 114, 117, 122, 123, 124, 128, 130, 141, 144, 145, 146, 151, 152, 153, 154, 155, 157, 160, 162, 165, 168, 173, 189.