PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (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) 722067, (2) 722225, (3) 722235 (OUS ONLY); UDI-DI: (1) 00884838085350, (2) 00884838099265, (3) 00884838116788; Serial Numbers: (1) 26, 150, 190, 278, 69, 141, 115, 221, 148, 46, 36, 42, 98, 123, 277, 92, 103, 192, 81, 57, 70, 225, 71, 131, 234, 109, 250, 114, 41, 214, 172, 173, 163, 104, 132, 147, 208, 244, 75, 133, 151, 188, 134, 22, 23, 268, 100, 101, 138, 54, 55, 276, 275, 105, 95, 32, 112, 97, 243, 224, 45, 108, 202, 113, 127, 76, 176, 165, 271, 272, 47, 256, 187, 154, 157, 265, 238, 207, 58, 169, 231, 226, 33, 159, 40, 120, 44, 121, 31, 28, 195, 196, 197, 179, 183, 185, 50, 78, 27, 85, 39, 91, 93, 94, 96, 239, 72, 119, 137, 189, 193, 117, 118, 89, 90, 167, 102, 84, 199, 73, 178, 129, 229, 252, 86, 79, 170, 227, 145, 63, 61, 49, 200, 21, 51, 194, 38, 186, 87, 56, 161, 110, 130, 80, 171, 245, 88, 175, 198, 139, 99, 37, 264, 266, 209, 255, 140, 59, 30, 206, 60, 156, 191, 142, 143, 144, 274, 52, 53, 107, 29, 232, 260, 64, 35, 203, 74, 48, 149, 251, 233, 222, 262, 273, 270, 218, 235, 111, 146, 237, 43, 68, 210, 211, 212, 213, 34, 254, 168; (2) 259, 260, 55, 268, 147, 375, 404, 112, 376, 228, 229, 453, 53, 72, 71, 300, 157, 340, 28, 207, 216, 217, 68, 177, 291, 299, 29, 249, 227, 289, 354, 148, 205, 235, 41, 141, 262, 37, 298, 331, 104, 46, 111, 84, 208, 122, 110, 233, 175, 153, 206, 456, 393, 387, 189, 200, 218, 345, 346, 114, 173, 431, 149, 258, 184, 237, 385, 167, 14, 364, 4, 398, 30, 231, 103, 38, 178, 1, 321, 326, 313, 320, 180, 116, 107, 342, 350, 373, 372, 343, 348, 349, 351, 186, 195, 302, 301, 170, 171, 82, 210, 330, 307, 73, 93, 108, 143, 15, 62, 361, 119, 286, 89, 90, 77, 369, 161, 179, 131, 132, 20, 155, 191, 244, 245, 212, 323, 27, 106, 35, 150, 317, 88, 118, 100, 163, 337, 139, 165, 166, 137, 138, 247, 162, 9, 67, 94, 95, 40, 391, 91, 12, 11, 213, 272, 117, 21, 54, 74, 64, 192, 204, 85, 238, 341, 125, 190, 16, 363, 80, 311, 275, 44, 370, 334, 70, 303, 75, 353, 360, 36, 282, 57, 115, 224, 377, 10, 316, 198, 424, 335, 34, 236, 23, 325, 322, 154, 211, 332, 127, 355, 69, 60, 61, 279, 402, 329, 278, 63, 277, 432, 281, 98, 197, 151, 379, 76, 194, 222, 13, 59, 280, 371, 164, 359, 193, 430, 319, 32, 121, 86, 240, 58, 266, 18, 19, 92, 221, 105, 160, 39, 42, 120, 219, 187, 396, 446, 367, 242, 423, 257, 312, 327, 152, 447, 448, 47, 48, 52, 333, 324, 392, 365, 83, 96, 255, 256, 159, 234, 128, 134, 135, 226, 223, 386, 287, 309, 310, 414, 99, 413, 246, 8, 426, 420, 315, 293, 169, 123, 220, 79, 201, 196, 31, 384, 87, 283, 374, 421, 422, 267, 454, 439, 284, 395, 146, 427, 314, 450, 140, 241, 306, 133, 158, 230, 269, 145, 232, 109, 338, 362, 168, 368, 292, 56, 433, 296, 5, 124, 290, 43, 248, 276, 17, 243, 142, 144, 274, 7, 65, 66, 214 ****Serial Numbers Added 5/2/2025**** 400, 405, 434, 435, 251, 252, 253, 254, 366; (3) OUS ONLY 10, 6, 7, 5, 4, 14 ****Serial Numbers Added 5/2/2025**** 3, 8, 9, 13, 17, 18, 19, 20, 21, 23, 24, 25, 28, 33, 34, 35, 39, 41, 44, 45, 47, 49, 52, 53, 54, 56, 58, 65, 70, 72.