PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 7

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) 722064, (2) 722222, (3) 722280(OUS ONLY); UDI-DI: (1) 00884838085282, (2) 00884838099210 (3) No UDI; Serial Numbers: (1) 267, 335, 260, 261, 209, 238, 64, 229, 218, 314, 291, 201, 270, 258, 341, 237, 35, 174, 151, 10, 82, 73, 74, 168, 125, 246, 302, 86, 81, 198, 165, 127, 274, 329, 200, 317, 179, 276, 167, 59, 58, 182, 249, 388, 112, 169, 297, 400, 458, 394, 265, 510, 502, 519, 520, 474, 441, 505, 416, 500, 387, 333, 468, 324, 504, 426, 320, 501, 413, 491, 236, 475, 311, 509, 488, 342, 389, 225, 473, 406, 457, 338, 508, 443, 513, 262, 427, 234, 469, 280, 401, 308, 304, 461, 422, 414, 310, 494, 312, 235, 322, 444, 498, 515, 449, 447, 483, 480, 448, 405, 463, 337, 470, 445, 462, 496, 247, 397, 344, 432, 503, 343, 407, 439, 517, 396, 386, 514, 454, 485, 472, 340, 476, 404, 477, 452, 442, 412, 395, 478, 479, 440, 330, 467, 492, 471, 285, 446, 385, 278, 36, 55, 94, 403, 228, 208, 40, 45, 66, 135, 136, 11, 96, 417, 156, 84, 190, 277, 256, 131, 148, 161, 162, 12, 57, 6, 69, 408, 282, 123, 62, 184, 51, 89, 100, 137, 61, 222, 50, 143, 49, 268, 7, 119, 118, 384, 68, 65, 121, 87, 180, 185, 193, 212, 213, 214, 266, 271, 72, 37, 245, 108, 91, 252, 292, 293, 321, 379, 138, 60, 130, 157, 263, 264, 110, 109, 133, 79, 490, 155, 451, 511, 484, 497, 67, 272, 323, 132, 102, 253, 275, 70, 251, 421, 43, 254, 106, 104, 122, 191, 47, 378, 75, 381, 227, 92, 207, 117, 126, 175, 166, 172, 429, 296, 114, 437, 294, 295, 419, 134, 188, 189, 283, 315, 284, 210, 116, 187, 199, 434, 241, 357, 313, 192, 255, 306, 164, 215, 319, 327, 144, 221, 5, 250, 46, 101, 431, 9, 177, 39, 226, 290, 393, 257, 78, 183, 269, 80, 425, 206, 309, 173, 220, 359, 354, 374, 41, 186, 48, 44, 149, 150, 176, 197, 230, 231, 233, 287, 288, 289, 380, 124, 373, 98, 147, 391, 345, 303; (2) 15, 19, 55, 265, 23, 226, 255, 254, 256, 257, 12, 99, 100, 120, 45, 187, 223, 367, 332, 44, 358, 69, 310, 17, 111, 356, 112, 113, 106, 51, 65, 188, 268, 77, 11, 109, 80, 68, 245, 83, 250, 251, 252, 253, 248, 270, 47, 21, 38, 54, 272, 64, 261, 165, 98, 211, 67, 326, 29, 10, 22, 173, 127, 368, 262, 190, 225, 184, 166, 143, 312, 322, 297, 364, 219, 189, 304, 183, 162, 168, 349, 318, 333, 169, 185, 311, 228, 180, 172, 296, 217, 181, 224, 278, 186, 161, 247, 193, 266, 313, 282, 244, 177, 50, 280, 354, 75, 246, 269, 126, 78, 108, 105, 124, 218, 125, 35, 146, 13, 300, 5, 9, 18, 249, 27, 31, 104, 53, 76, 107, 243, 66, 215, 267, 324, 281, 229, 213, 117, 178, 92, 287, 88, 89, 102, 118, 119, 145, 209, 210, 331, 351, 361, 372, 373, 288, 289, 290, 291, 292, 294, 295, 319, 212, 192, 149, 321, 115, 82, 316, 133, 174, 230, 307, 320, 336, 338, 339, 340, 344, 362, 141, 37, 182, 308, 142, 96, 378, 365, 366, 370, 374, 135, 73, 159, 157, 158, 114, 87, 274, 214, 116, 276, 132, 277, 353, 14, 72, 151, 152, 138, 56, 137, 302, 363, 4, 24, 90, 131, 263, 16, 314, 315, 110, 305, 139, 134, 222, 369, 375, 284, 48 ****Serial numbers Added 5/2/2025**** 328, 335,343, 345, 346, 376, 379, 380, 382, 383, 384, 385, 386, 389, 392, 396; (3) (OUS ONLY) 79, 196, 126, 131, 142, 143, 144, 133, 162, 152, 167, 44, 129, 199, 147, 112, 98, 36, 137, 101, 150, 210, 170, 34, 123, 125, 124, 113, 39, 81, 42, 41, 93, 37, 100, 95, 22, 43, 171, 58, 49, 158, 20, 19, 88, 87, 165, 207, 63, 76, 48, 164, 83, 54, 45, 38, 179, 127, 175, 157, 128, 140, 99, 132, 35, 145, 91, 92, 96, 161, 205, 66, 174, 74, 69, 209, 206, 61, 118, 84, 94, 108, 148, 24, 72, 105, 208, 47, 33, 53, 90, 187, 130, 57, 85, 86, 153, 80, 106, 149, 55, 173, 103, 177, 178, 119, 46, 135, 17, 107, 65, 102, 141, 160, 52, 71, 60, 59, 120, 189, 114, 97, 73, 50, 82, 21, 30, 23, 110, 40, 151, 146, 117 ****Serial Numbers Added 5/2/2025**** 68, 138, 194, 197, 198, 204, 211, 212, 215, 216, 218, 220, 226, 231.