PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Is this relevant to me?

Geography

Nationwide

Source agency

FDA

Category

Health

Published

September 3, 2025

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.

What's affected?

Product

Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

Brand

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Lot code

Model Numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) N/A, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 233, 321, 435, 285, 384, 388, 343, 399, 392, 128, 355, 51, 367, 348, 160, 271, 530, 112, 70, 520, 323, 49, 329, 365, 269, 270, 523, 490, 346, 129, 258, 298, 316, 485, 261, 169, 427, 352, 474, 497, 251, 100, 456, 360, 305, 419, 405, 489, 306, 307, 467, 234, 333, 533, 209, 369, 543, 332, 328, 366, 339, 389, 538, 394, 378, 379, 237, 165, 2724, 238, 415, 473, 482, 397, 53, 385, 52, 447, 96, 429, 159, 531, 58, 499, 229, 374, 25, 354, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 561, 511, 478, 428, 500, 464, 463, 14, 459, 416, 359, 487, 564, 469, 72, 125, 494, 76, (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 332, 102, 270, 177, 132, 325, 15, 79, 76, 17, 87, 255, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 189, 186, 118, 119, 300, 213, 372, 12, 55, 41, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 75, 307, 301, 18, 302, 303, 304, 305, 306, 293, 294, 184, 266, 146, 116, 68, 310, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 141, 139, 77, 99, 277, 313, 223, 27, 26, 29, 340, 69, 374, 328, 228, 251, 231, 323, 224, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 86, 378, 376, 377, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 318, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 104, 290, 244, 333, 287, 38, 39, 176, 282, 216, 158, 329, 246, 295, 56, 337, 292, 125, (3) 203, 335, 123, 133, 134, 284, 280, 183, 169, 106, 107, 234, 42, 101, 307, 265, 306, 267, 209, 153, 40, 332, 156, 112, 305, 1, 104, 263, 342, 71, 255, 351, 298, 175, 120, 116, 174, 241, 240, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 187, 321, 328, 282, 184, 53, 146, 35, 337, 357, 213, 293, 292, 170, 346, 211, 95, 144, 238, 247, 154, 188, 347, 196, 159, 339, 343, 256, 167, 338, 334, 162, 273, 5, 160, 246, 61, 36, 299, 294, 345, 76, 94, 350, 348, 349, 172, 323, 324, 151, 7, 44, 99, 189, 85, 102, 78, 212, 126, 81, 268, 356, 244, 221, 55, 86, 254, 6, 117, 113, 362, 271, 186, 259, 236, 201, 275, 135, 277, 3, 58, 249, 149, 148, 38, 47, 316, 27, 165, 274, 80, 64, 205, 223, 270, 181, 245, 46, 352, 358, 361, 60, 228, 142, 57, 100, 70, 214, 145, 30, 114, 115, 204, 225, 297, 182, 48, 110, 84, 132, 177, 300, 79, 130, 210, 82, 260, 261, 103, 322, 128, 360, 310, 125, 68, 291, 180, 287, 264, 272, 59, 155, 207, 122, 45, 166, 158, 239, 33, 31, 137, 308, 243, 242, 131, 218, 66, 147, 197, 168, 118, 73, 235, 278, 250, 227, 96, 119, 233, 329, 296, 193, 143, 219, 276, 326, 312, 304, 311, 199, 75, 121, 87, 91, 192, 289, 217, 355, 232, 67, 315, 69, 19, 34, 141, 18, 138, 309, 51, 171, 136, 191, 269, 62, 206, 330, 90, 195, 215, 88, 139, 220, 198, 150, 208, 28, 163, 286, 23, 24, 21, 20, 65;

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