PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

Is this relevant to me?

Geography

Nationwide

Source agency

FDA

Category

Health

Published

March 3, 2026

Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., 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, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen;

What's affected?

Product

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

Brand

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Lot code

(1) System Code: 722064; UDI: 00884838085282; System Serial Number: 209, 238, 201, 258, 260, 261, 314, 229, 291, 270, 267, 218, 335, 513, 61, 161, 162, 169, 297, 131, 479, 190, 268, 173, 220, 256, 290, 502, 425, 412, 89, 303, 130, 157, 60, 263, 264, 253, 254, 257, 280, 373, 417, 9, 277, 102, 467, 461, 137, 46, 101, 84, 510, 5, 78, 49, 345, 180, 185, 266, 271, 193, 212, 213, 214, 431, 250, 186, 246, 282, 354, 374, 274, 127, 451, 106, 490, 329, 276, 58, 81, 200, 179, 249, 156, 184, 6, 448, 10, 82, 323, 35, 69, 278, 511, 39, 40, 45, 66, 125, 484, 36, 94, 497, 104, 422, 132, 67, 183, 439, 70, 446, 50, 138, 292, 293, 321, 379, 151, 237, 519, 520, 208, 462, 342, 57, 222, 391, 98, 441, 320, 494, 79, 65, 87, 109, 75, 311, 442, 485, 121, 68, 384, 228, 252, 91, 73, 74, 124, 191, 122, 421, 119, 309, 400, 251, 468, 480, 387, 269, 111, 11, 147, 509, 454, 478, 262, 491, 133, 337, 275, 414, 405, 396, 247, 310, 406, 517, 432, 457, 426, 304, 469, 340, 393, 343, 458, 322, 444, 508, 445, 395, 385, 505, 472, 514, 333, 236, 471, 234, 503, 394, 407, 470, 498, 504, 413, 7, 440, 463, 330, 475, 473, 501, 308, 225, 483, 474, 344, 389, 492, 324, 265, 235, 120, 496, 427, 341, 287, 288, 289, 380, 149, 150, 176, 197, 230, 231, 233, 44, 100, 51, 388, 118, 62, 123, 177, 47, 272, 110, 59, 167, 174, 165, 401, 452, 41, 168, 447, 148, 182, 112, 302, 86, 317, 198, 378, 206, 136, 312, 143, 403, 386, 397, 500, 226, 408, 43, 381, 488, 443, 416, 80, 12, 404, 285, 515, 476, 449, 477, 338, 419, 215, 164, 434, 114, 144, 327, 227, 295, 294, 319, 241, 126, 92, 284, 175, 199, 372, 188, 429, 296, 172, 283, 357, 306, 437, 210, 315, 134, 255, 207, 192, 116, 221, 189, 117, 313, 187, 166, 96, 135, 108, 37, 245, 72; (2) System Code: 722222; UDI: 00884838099210; System Serial Number: 332, 111, 254, 256, 257, 265, 255, 100, 99, 310, 69, 12, 226, 15, 19, 23, 17, 55, 45, 187, 223, 358, 112, 113, 367, 120, 356, 262, 37, 318, 152, 364, 146, 246, 269, 75, 304, 316, 174, 230, 307, 320, 336, 338, 339, 340, 343, 344, 345, 346, 362, 308, 182, 27, 56, 312, 368, 172, 137, 302, 328, 35, 383, 96, 382, 151, 138, 384, 363, 224, 386, 395, 102, 118, 119, 145, 209, 210, 331, 351, 372, 373, 361, 88, 89, 108, 132, 48, 53, 4, 305, 80, 83, 47, 270, 21, 64, 22, 98, 29, 248, 266, 378, 245, 18, 24, 335, 177, 11, 72, 244, 9, 66, 50, 263, 65, 278, 82, 188, 68, 51, 5, 76, 243, 139, 319, 31, 193, 106, 392, 287, 178, 117, 267, 92, 324, 213, 281, 229, 215, 300, 268, 104, 353, 141, 133, 142, 105, 250, 251, 252, 253, 183, 375, 311, 228, 322, 189, 297, 190, 313, 169, 219, 247, 282, 217, 143, 349, 225, 162, 333, 185, 166, 161, 369, 134, 222, 389, 370, 374, 396, 399, 280, 249, 115, 321, 211, 168, 127, 261, 54, 14, 38, 10, 67, 165, 272, 326, 173, 90, 109, 13, 288, 289, 290, 291, 294, 295, 292, 186, 181, 107, 379, 385, 296, 314, 315, 390, 77, 354, 380, 110, 184, 180, 131, 284, 376, 366, 214, 116, 276, 73, 365, 398, 157, 87, 114, 274, 135, 159, 158, 78, 125, 218, 124, 126, 192, 212, 149; (3) System Code: 722230; UDI: 00884838116733; System Serial Number: 40, 2, 22, 10, 50, 4, 5, 19, 20, 23, 25, 30, 41, 67, 7, 45, 15, 28, 60, 38, 9, 62, 63, 57, 58, 54, 55, 39, 27, 52, 13, 12, 1, 68; (4) System Code: 722280; UDI: 00884838103276; System Serial Number: 57, 161, 43, 179, 229, 249, 65, 76, 232, 113, 167, 165, 80, 128, 158, 149, 194, 44, 100, 164, 240, 246, 66, 135, 175, 99, 112, 34, 79, 130, 48, 52, 141, 131, 142, 143, 144, 189, 37, 83, 223, 139, 87, 61, 259, 218, 90, 188, 105, 23, 30, 132, 96, 107, 171, 118, 21, 174, 220, 147, 133, 264, 38, 243, 177, 178, 150, 69, 148, 210, 207, 98, 211, 127, 222, 198, 71, 146, 241, 206, 152, 262, 157, 40, 17, 204, 260, 187, 208, 46, 235, 234, 91, 97, 153, 245, 106, 173, 258, 120, 45, 92, 226, 254, 213, 224, 95, 54, 126, 216, 19, 271, 215, 93, 24, 129, 74, 219, 88, 85, 86, 170, 55, 102, 123, 124, 125, 151, 39, 47, 101, 209, 41, 42, 53, 250, 239, 248, 108, 119, 205, 197, 82, 33, 20, 231, 63, 261, 138, 255, 212, 84, 221, 36, 247, 256, 59, 196, 50, 110, 199, 140, 68, 117, 49, 257, 60, 103, 237, 72, 160, 81, 114, 137, 58, 73, 35, 22, 94;

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