Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

Recall: Z-1158-2025 · Reported February 26, 2025

Enforcement

Recall Number: Z-1158-2025
Event ID: 96132
Classification: Class I
Status: Ongoing
Product Type: Devices
Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: February 26, 2025
Initiation Date: January 13, 2025
Classification Date: February 20, 2025
Address: Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

Description

Reason

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

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.

Distribution

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

Quantity

1,314 units (270 US, 1044 OUS)