Skip to content
Recall Observatory FDA recall evidence

Device product

Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

Z-2627-2025

September 03, 2025

Class II

Product summary

Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Event
Event 97501
Status
Ongoing
Classification
Class II
Quantity
268 units (102 US, 166 OUS)
Official record key
device-enforcement:Z-2627-2025

Official wording

Reason: Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

Code information: Product Codes: (1)722013, (2) 722008; UDI-DI: (1) 00884838059061, (2) N/A; Serial numbers: (1) 505, 313, 34, 153, 410, 360, 290, 241, 404, 126, 244, 106, 346, 383, 461, 307, 442, 435, 293, 289, 267, 214, 402, 86, 603, 149, 424, 140, 254, 255, 266, 518, 519, 303, 115, 150, 129, 496, 441, 124, 151, 550, 575, 562, 178, 330, 309, 601, 308, 264, 268, 141, 175, 85, 216, 422, 174, 228, 511, 152, 561, 262, 626, 497, 170, 379, 125, 564, 426, 495, 500, 515, 105, 428, 427, 531, 375, 316, 278, 347, 462, 249, 246, 639, 304, 147, 607, 567, 168, 171, 265, 332, 295, 589, 444, 447, 400, 384, 538, 117, 620, 624, 623, 215, 416, 415, 47, 335, 619, 598, 361, 358, 549, 133, 476, 315, 616, 630, 417, 490, 528, 525, 247, 618, 372, 613, 478, 544, 585, 608, 296, 570, 547, 138, 318, 345, 139, 473, 388, 434, 502, 586, 334, 411, 501, 458, 261, 429, 353, 395, 128, 348, 503, 557, 493, 563, 250, 595, 406, 355, 57, 394, 535, 569, 522, 465, 533, 412, 95, 344, 354, 425, 542, 207, 555, 524, 574, 366, 527, 325, 470, 440, 144, 403, 448, 134, 380, 487, 374, 256, 405, 367, 455, 302, 300, 299, 239, 506, 243, 324, 311, 70, 161, 449, 321, 176, 181, 554, 167, 130, 378, 158, 237, 453, 165, 532, 223, 343, 291, 370, 193, 163, 526, 236, 156, 368, 499, 443, 540, 259, (2) 224, 105, 312, 197, 264, 294, 246, 231, 521, 413, 18, 19, 267, 487, 69, 386, 205, 416, 513, 337, 327, 122, 259, 150, 547, 408, 160, 388, 283, 359, 435, 370, 323, 128, 455, 266, 468, 46;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Fiji, Finland, France, FrenchPolynesia, Georgia, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Lao, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.