Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133...
FDA Recall #Z-0010-2026 — Class II — September 3, 2025
Product Description
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Reason for Recall
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.
Recalling Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
300 units (69 US, 231 OUS)
Distribution
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.
Code Information
Model Numbers: 722058; UDI-DI: 00884838059115; Serial Numbers: 337, 178, 249, 22, 202, 279, 254, 285, 71, 186, 82, 85, 162, 138, 24, 365, 203, 167, 146, 168, 304, 172, 200, 123, 129, 149, 259, 4, 197, 134, 38, 290, 171, 56, 264, 238, 199, 61, 156, 99, 65, 59, 109, 100, 305, 319, 215, 278, 124, 196, 405, 325, 265, 378, 277, 274, 94, 182, 366, 340, 190, 219, 373, 239, 23, 205, 257, 212, 111, 110, 399, 72, 332, 92, 142, 67, 106, 335, 360, 415, 11, 114, 151, 93, 232, 395, 292, 380, 183, 349, 261, 15, 375, 161, 78, 368, 9, 372, 288, 252, 320, 213, 293, 389, 169, 97, 336, 25, 143, 133, 192, 49, 412, 201, 89, 66, 163, 170, 77, 273, 35, 222, 229, 248, 334, 384, 40, 268, 240, 258, 289, 269, 226, 244, 48, 141, 391, 241, 164, 381, 281, 154, 246, 127, 315, 256, 233, 348, 204, 396, 7, 185, 95, 131, 377, 60, 68, 206, 101, 150, 333, 84, 398, 313, 3, 39, 344, 376, 382, 370, 387, 419, 394, 407, 413, 392, 411, 358, 409, 385, 416, 367, 379, 331, 418, 356, 421, 369, 420, 397, 357, 408, 393, 388, 108, 211, 126, 125, 301, 12, 30, 355, 354, 159, 139, 128, 81, 58, 96, 343, 177, 115, 19, 18, 311, 220, 386, 291, 327, 214, 145, 223, 137, 136, 119, 103, 404, 27, 32, 350, 400, 422, 423, 347, 73, 43, 55, 194, 189, 237, 230, 221, 247, 116, 242, 29, 37, 276, 345, 166, 179, 53, 87, 303, 90, 112, 245, 148, 41, 234, 208, 117, 193, 76, 236, 266, 130, 235, 251, 86, 31, 195, 144, 330, 63, 295, 70, 187, 79, 10, 33, 75, 361, 153, 284, 102, 21, 64, 45, 36, 181, 351, 272, 210, 243, 20, 98, 34, 16, 218;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.