Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

Recall details

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Distributor

Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.

Lot

Catalog numbers: (1) 722064, (2) 722222, (3) 722280(OUS ONLY); UDI-DI: (1) 00884838085282, (2) 00884838099210 (3) No UDI; Serial Numbers: (1) 267, 335, 260, 261, 209, 238, 64, 229, 218, 314, 291, 201, 270, 258, 341, 237, 35, 174, 151, 10, 82, 73, 74, 168, 125, 246, 302, 86, 81, 198, 165, 127, 274, 329, 200, 317, 179, 276, 167, 59, 58, 182, 249, 388, 112, 169, 297, 400, 458, 394, 265, 510, 502, 519, 520, 474, 441, 505, 416, 500, 387, 333, 468, 324, 504, 426, 320, 501, 413, 491, 236, 475, 311, 509, 488, 342, 389, 225, 473, 406, 457, 338, 508, 443, 513, 262, 427, 234, 469, 280, 401, 308, 304, 461, 422, 414, 310, 494, 312, 235, 322, 444, 498, 515, 449, 447, 483, 480, 448, 405, 463, 337, 470, 445, 462, 496, 247, 397, 344, 432, 503, 343, 407, 439, 517, 396, 386, 514, 454, 485, 472, 340, 476, 404, 477, 452, 442, 412, 395, 478, 479, 440, 330, 467, 492, 471, 285, 446, 385, 278, 36, 55, 94, 403, 228, 208, 40, 45, 66, 135, 136, 11, 96, 417, 156, 84, 190, 277, 256, 131, 148, 161, 162, 12, 57, 6, 69, 408, 282, 123, 62, 184, 51, 89, 100, 137, 61, 222, 50, 143, 49, 268, 7, 119, 118, 384, 68, 65, 121, 87, 180, 185, 193, 212, 213, 214, 266, 271, 72, 37, 245, 108, 91, 252, 292, 293, 321, 379, 138, 60, 130, 157, 263, 264, 110, 109, 133, 79, 490, 155, 451, 511, 484, 497, 67, 272, 323, 132, 102, 253, 275, 70, 251, 421, 43, 254, 106, 104, 122, 191, 47, 378, 75, 381, 227, 92, 207, 117, 126, 175, 166, 172, 429, 296, 114, 437, 294, 295, 419, 134, 188, 189, 283, 315, 284, 210, 116, 187, 199, 434, 241, 357, 313, 192, 255, 306, 164, 215, 319, 327, 144, 221, 5, 250, 46, 101, 431, 9, 177, 39, 226, 290, 393, 257, 78, 183, 269, 80, 425, 206, 309, 173, 220, 359, 354, 374, 41, 186, 48, 44, 149, 150, 176, 197, 230, 231, 233, 287, 288, 289, 380, 124, 373, 98, 147, 391, 345, 303; (2) 15, 19, 55, 265, 23, 226, 255, 254, 256, 257, 12, 99, 100, 120, 45, 187, 223, 367, 332, 44, 358, 69, 310, 17, 111, 356, 112, 113, 106, 51, 65, 188, 268, 77, 11, 109, 80, 68, 245, 83, 250, 251, 252, 253, 248, 270, 47, 21, 38, 54, 272, 64, 261, 165, 98, 211, 67, 326, 29, 10, 22, 173, 127, 368, 262, 190, 225, 184, 166, 143, 312, 322, 297, 364, 219, 189, 304, 183, 162, 168, 349, 318, 333, 169, 185, 311, 228, 180, 172, 296, 217, 181, 224, 278, 186, 161, 247, 193, 266, 313, 282, 244, 177, 50, 280, 354, 75, 246, 269, 126, 78, 108, 105, 124, 218, 125, 35, 146, 13, 300, 5, 9, 18, 249, 27, 31, 104, 53, 76, 107, 243, 66, 215, 267, 324, 281, 229, 213, 117, 178, 92, 287, 88, 89, 102, 118, 119, 145, 209, 210, 331, 351, 361, 372, 373, 288, 289, 290, 291, 292, 294, 295, 319, 212, 192, 149, 321, 115, 82, 316, 133, 174, 230, 307, 320, 336, 338, 339, 340, 344, 362, 141, 37, 182, 308, 142, 96, 378, 365, 366, 370, 374, 135, 73, 159, 157, 158, 114, 87, 274, 214, 116, 276, 132, 277, 353, 14, 72, 151, 152, 138, 56, 137, 302, 363, 4, 24, 90, 131, 263, 16, 314, 315, 110, 305, 139, 134, 222, 369, 375, 284, 48 ****Serial numbers Added 5/2/2025**** 328, 335,343, 345, 346, 376, 379, 380, 382, 383, 384, 385, 386, 389, 392, 396; (3) (OUS ONLY) 79, 196, 126, 131, 142, 143, 144, 133, 162, 152, 167, 44, 129, 199, 147, 112, 98, 36, 137, 101, 150, 210, 170, 34, 123, 125, 124, 113, 39, 81, 42, 41, 93, 37, 100, 95, 22, 43, 171, 58, 49, 158, 20, 19, 88, 87, 165, 207, 63, 76, 48, 164, 83, 54, 45, 38, 179, 127, 175, 157, 128, 140, 99, 132, 35, 145, 91, 92, 96, 161, 205, 66, 174, 74, 69, 209, 206, 61, 118, 84, 94, 108, 148, 24, 72, 105, 208, 47, 33, 53, 90, 187, 130, 57, 85, 86, 153, 80, 106, 149, 55, 173, 103, 177, 178, 119, 46, 135, 17, 107, 65, 102, 141, 160, 52, 71, 60, 59, 120, 189, 114, 97, 73, 50, 82, 21, 30, 23, 110, 40, 151, 146, 117 ****Serial Numbers Added 5/2/2025**** 68, 138, 194, 197, 198, 204, 211, 212, 215, 216, 218, 220, 226, 231.

Risk classification

Class I

Area (FDA)

device

Country

Netherlands