BEUDAMED
    FDA Enforcement Class II Ongoing

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    Recall: Z-0010-2026 · Reported October 8, 2025

    Enforcement

    Recall Number
    Z-0010-2026
    Event ID
    97502
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 8, 2025
    Initiation Date
    September 3, 2025
    Classification Date
    October 1, 2025
    Address
    Veenpluis 4-6, N/A, Best, N/A, N/A, Netherlands

    Description

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    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 Info

    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;

    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.

    Quantity

    300 units (69 US, 231 OUS)