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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1145-2025

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

Publicado el 26 de febrero de 2025 · Inicio del retiro: 13 de enero de 2025

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distribuidor
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.
Lote
Catalog numbers: (1) 722008, (2) 722013; UDI-DI: (1) No UDI, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 312, 319, 516, 244, 453, 306, 378, 124, 18270, 524, 463, 197, 264, 294, 246, 320, 357, 212, 459, 472, 483, 465, 419, 38, 454, 441, 460, 369, 407, 231, 437, 105, 420, 1178, 270, 442, 521, 372, 254, 365, 390, 413, 379, 18, 239, 288, 424, 279, 481, 304, 267, 361, 415, 245, 445, 296, 487, 349, 456, 470, 386, 37, 205, 371, 416, 339, 513, 355, 337, 476, 121, 169, 327, 289, 518, 242, 93, 542, 122, 376, 543, 87, 391, 499, 253, 259, 393, 447, 495, 250, 110, 273, 31, 553, 433, 63, 398, 546, 213, 356, 408, 404, 448, 305, 475, 6001385, 425, 435, 450, 480, 370, 167, 323, 247, 525, 455, 394, 160, 350, 406, 274, 388, 283, 359, 8, 346, 335, 458, 410, 367, 266, 268, 482, 272, 385, 290, 468, 446, 46, 334 ****Serial Numbers Added 5/2/2025**** 378, 379, 516, 242, 274, 335, 367, 371, 393; (2) 505, 217, 313, 113, 34, 153, 410, 360, 290, 74, 83, 580, 160, 404, 126, 244, 106, 346, 383, 461, 307, 1, 442, 435, 293, 253, 297, 46, 289, 638, 342, 69, 267, 214, 402, 86, 603, 82, 149, 424, 140, 254, 255, 266, 475, 518, 519, 303, 194, 115, 150, 129, 496, 599, 441, 124, 151, 179, 550, 377, 575, 631, 562, 178, 330, 309, 601, 327, 73, 264, 78, 268, 308, 141, 175, 357, 85, 40, 216, 637, 422, 174, 109, 218, 228, 511, 389, 152, 479, 561, 262, 626, 61, 164, 497, 379, 84, 125, 241, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 205, 246, 43, 639, 35, 480, 304, 634, 147, 15, 607, 52, 567, 283, 168, 171, 265, 509, 332, 272, 295, 97, 589, 444, 447, 292, 400, 628, 384, 206, 559, 538, 117, 629, 620, 624, 623, 215, 454, 416, 415, 47, 335, 222, 619, 598, 445, 361, 358, 549, 133, 476, 315, 36, 31, 390, 630, 17, 633, 417, 490, 48, 528, 53, 238, 525, 276, 560, 157, 247, 618, 372, 224, 76, 613, 478, 50, 544, 172, 232, 530, 349, 585, 608, 66, 296, 271, 359, 570, 457, 547, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 107, 138, 225, 58, 29, 227, 318, 345, 139, 473, 388, 434, 64, 502, 586, 394, 275, 334, 411, 501, 450, 208, 408, 458, 258, 261, 429, 353, 395, 128, 348, 503, 557, 493, 563, 103, 396, 551, 250, 595, 406, 510, 355, 57, 535, 137, 569, 522, 436, 465, 201, 533, 135, 412, 95, 294, 344, 354, 425, 542, 207, 622, 182, 555, 524, 574, 366, 527, 324, 311, 459, 70, 161, 449, 321, 176, 65, 181, 554, 104, 167, 312, 130, 325, 470, 440, 144, 28, 385, 403, 448, 81, 380, 374, 256, 405, 60, 108, 468, 367, 455, 191, 301, 302, 352, 62, 300, 299, 71, 239, 506, 243, 378, 632, 110, 111, 158, 237, 453, 165, 364, 532, 223, 343, 291, 22, 370, 193, 163, 526, 236, 132, 156, 368, 177, 443, 259, 540 ****Serial Numbers Added 5/2/2025**** 35, 72, 73, 82, 113, 160, 480, 580, 76, 97, 272, 292, 396.
Clasificación de riesgo
Class I
Área (FDA)
device
País
Netherlands

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