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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1664-2026

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

Publicado el 8 de abril de 2026 · Inicio del retiro: 3 de marzo de 2026

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

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distribuidor
Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen;
Lote
(1) System Code: 722008; UDI: N/A; System Serial Number: 360, 361, 445, 296, 487, 390, 306, 178, 420, 267, 245, 2470, 491, 113, 386, 69, 413, 365, 454, 304, 442, 125, 441, 320, 325, 112, 254, 456, 52, 34, 239, 407, 187, 437, 82, 102, 288, 349, 106, 105, 481, 71, 424, 1236, 197, 264, 18, 19, 192, 124, 483, 244, 224, 470, 279, 141, 459, 357, 287, 116, 521, 369, 212, 23, 415, 100, 294, 270, 372, 472, 18270, 154, 231, 108, 1178, 246, 115, 460, 319, 465, 142, 419, 312, 37, 59, 455, 217, 350, 406, 160, 167, 435, 447, 410, 196, 458, 480, 476, 370, 169, 121, 259, 266, 186, 290, 253, 359, 391, 283, 205, 425, 346, 376, 150, 394, 123, 513, 337, 93, 268, 200, 87, 110, 46, 542, 334, 122, 8, 468, 250, 482, 63, 408, 305, 213, 547, 546, 475, 356, 404, 398, 31, 553; (2) System Code: 722013; UDI: 00884838059061; System Serial Number: 293, 424, 100, 174, 86, 83, 46, 170, 218, 441, 249, 639, 290, 153, 410, 1, 289, 518, 519, 626, 126, 141, 496, 379, 115, 42, 601, 214, 637, 360, 389, 303, 268, 264, 631, 254, 255, 515, 129, 15, 603, 278, 347, 426, 505, 109, 462, 149, 124, 216, 246, 84, 479, 69, 105, 638, 375, 531, 404, 575, 147, 475, 262, 125, 316, 497, 357, 495, 573, 342, 564, 164, 178, 556, 253, 297, 511, 492, 43, 550, 96, 179, 228, 194, 151, 106, 330, 461, 304, 40, 85, 72, 241, 422, 267, 150, 428, 634, 327, 442, 175, 217, 313, 346, 308, 562, 309, 152, 34, 561, 35, 205, 61, 435, 266, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 138, 223, 343, 165, 453, 370, 367, 108, 352, 291, 259, 455, 368, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 183, 184, 185, 186, 187, 188, 189, 190, 413, 437, 560, 300, 295, 448, 81, 444, 400, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 476, 527, 276, 247, 156, 499, 50, 302, 618, 608, 133, 70, 457, 547, 312, 366, 390, 544, 236, 157, 243, 144, 238, 525, 53, 570, 161, 349, 359, 454, 613, 623, 222, 215, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 470, 378, 296, 227, 31, 58, 589, 616, 71, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 528, 318, 28, 237, 559, 372, 256, 374, 487, 405, 380, 434, 130, 473, 551, 557, 294, 412, 128, 388, 207, 258, 429, 95, 411, 353, 542, 533, 622, 182, 574, 139, 137, 250, 563, 502, 450, 436, 406, 354, 510, 395, 458, 261, 348, 503, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 522, 64, 208, 408, 555, 394, 57, 493;
Clasificación de riesgo
Class II
Área (FDA)
device
País
Netherlands

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