Skip to content
Recall Observatory FDA recall evidence

Device product

Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Z-0006-2026

September 03, 2025

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 97502
Status
Ongoing
Classification
Class II
Quantity
501 units (212 US, 289 OUS)
Official record key
device-enforcement:Z-0006-2026

Official wording

Reason: The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Code information: Model Numbers: (1) 722008, (2) 722013; UDI-DI: (1) N/A, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 125, 312, 319, 82, 192, 244, 453, 306, 116, 124, 18270, 524, 106, 224, 463, 197, 264, 100, 294, 246, 357, 212, 287, 154, 459, 71, 112, 472, 483, 465, 419, 38, 454, 2470, 441, 460, 369, 407, 102, 231, 94, 437, 420, 1178, 108, 270, 442, 521, 372, 113, 34, 187, 254, 365, 390, 413, 52, 18, 19, 239, 288, 424, 279, 115, 481, 141, 304, 267, 361, 415, 178, 245, 445, 23, 296, 487, 349, 456, 470, 386, 69, 1236, 37, 59, 455, 217, 446, 272, 160, 406, 350, 167, 247, 416, 435, 48, 447, 179, 410, 196, 458, 525, 480, 476, 370, 327, 169, 121, 259, 266, 128, 186, 290, 385, 253, 450, 359, 391, 283, 323, 205, 425, 346, 388, 376, 150, 394, 123, 339, 513, 337, 93, 268, 200, 87, 110, 46, 542, 530, 334, 122, 468, 250, 482, 63, 305, 213, 546, 273, 433, 475, 398, 31, (2) 505, 313, 217, 492, 34, 410, 153, 360, 290, 74, 83, 241, 404, 126, 244, 106, 383, 346, 461, 307, 1, 442, 435, 293, 253, 297, 46, 289, 638, 342, 69, 267, 402, 214, 86, 603, 149, 424, 140, 254, 255, 266, 475, 519, 518, 303, 194, 115, 150, 129, 496, 599, 441, 124, 151, 179, 550, 377, 575, 631, 562, 178, 330, 309, 601, 327, 308, 264, 78, 268, 141, 175, 357, 85, 40, 216, 637, 422, 174, 109, 72, 218, 228, 511, 389, 152, 479, 561, 262, 626, 61, 164, 497, 170, 379, 84, 125, 564, 573, 426, 556, 42, 100, 495, 500, 96, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 205, 246, 43, 639, 304, 634, 147, 15, 567, 168, 607, 283, 52, 171, 66, 36, 585, 271, 117, 443, 107, 343, 223, 385, 165, 453, 370, 22, 367, 108, 352, 291, 71, 259, 455, 468, 368, 239, 315, 325, 532, 598, 440, 172, 193, 301, 415, 540, 62, 299, 184, 185, 187, 188, 437, 189, 183, 186, 190, 413, 191, 560, 490, 300, 295, 81, 448, 444, 400, 632, 110, 111, 624, 65, 633, 630, 361, 549, 417, 449, 506, 177, 629, 48, 476, 527, 276, 247, 156, 499, 50, 167, 132, 302, 618, 608, 265, 70, 457, 547, 312, 321, 366, 390, 544, 236, 157, 243, 144, 525, 238, 570, 161, 349, 359, 454, 613, 623, 222, 335, 445, 538, 416, 628, 619, 47, 206, 620, 384, 526, 332, 358, 509, 470, 378, 296, 227, 31, 58, 589, 616, 447, 530, 232, 324, 311, 176, 181, 554, 134, 163, 104, 403, 478, 459, 17, 2266, 528, 318, 29, 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, 524, 354, 510, 395, 458, 261, 503, 348, 595, 586, 535, 569, 425, 334, 344, 355, 465, 345, 501, 522, 64, 396, 408, 208, 555, 394, 57, 493, 201;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, 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, T¿rkiye, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.