Device product
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Z-1664-2026
Product summary
- Event
- Event 98434
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 461 units (198 US, 263 OUS)
- Official record key
device-enforcement:Z-1664-2026
Official wording
Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Code information: (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;
Distribution pattern: 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;
Derived failure modes
-
Unknown
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.