CLASS II ONGOING Device recall · Reported 4 Nov 2026 · FDA Enforcement Report

Philips Azurion 3 M15 recalled by Philips Medical Systems Nederl

Philips Medical Systems Nederl is recalling Philips Azurion 3 M15, distributed nationwide in the US. The recall was initiated on 6 Oct 2026 and the FDA has classified it as Class II.

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Lot, batch or date codes1. Model Number: 722064. UDI Numbers: (01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)161, (01)00884838085282(21)169, (01)00884838085282(21)297, (01)00884838085282(21)479, (01)00884838085282(21)190, (01)00884838085282(21)268, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)359, (01)00884838085282(21)256, (01)00884838085282(21)290, (01)00884838085282(21)502, (01)00884838085282(21)130, (01)00884838085282(21)157, (01)00884838085282(21)264, (01)00884838085282(21)60, (01)00884838085282(21)263, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)9, (01)00884838085282(21)102, (01)00884838085282(21)467, (01)00884838085282(21)421, (01)00884838085282(21)510, (01)00884838085282(21)345, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)180, (01)00884838085282(21)185, (01)00884838085282(21)193, (01)00884838085282(21)214, (01)00884838085282(21)271, (01)00884838085282(21)213, (01)00884838085282(21)431, (01)00884838085282(21)246, (01)00884838085282(21)354, (01)00884838085282(21)374, (01)00884838085282(21)106, (01)00884838085282(21)58, (01)00884838085282(21)231, (01)00884838085282(21)287, (01)00884838085282(21)44, (01)00884838085282(21)176, (01)00884838085282(21)149, (01)00884838085282(21)197, (01)00884838085282(21)289, (01)00884838085282(21)288, (01)00884838085282(21)150, (01)00884838085282(21)233, (01)00884838085282(21)230, (01)00884838085282(21)380, (01)00884838085282(21)448, (01)00884838085282(21)82, (01)00884838085282(21)323, (01)00884838085282(21)35, (01)00884838085282(21)55, (01)00884838085282(21)278, (01)00884838085282(21)66, (01)00884838085282(21)45, (01)00884838085282(21)40, (01)00884838085282(21)125, (01)00884838085282(21)484, (01)00884838085282(21)36, (01)00884838085282(21)104, (01)00884838085282(21)155, (01)00884838085282(21)422, (01)00884838085282(21)132, (01)00884838085282(21)67, (01)00884838085282(21)183, (01)00884838085282(21)439, (01)00884838085282(21)446, (01)00884838085282(21)138, (01)00884838085282(21)321, (01)00884838085282(21)293, (01)00884838085282(21)292, (01)00884838085282(21)379, (01)00884838085282(21)151, (01)00884838085282(21)237, (01)00884838085282(21)5, (01)00884838085282(21)520, (01)00884838085282(21)519, (01)00884838085282(21)208, (01)00884838085282(21)462, (01)00884838085282(21)342, (01)00884838085282(21)57, (01)00884838085282(21)222, (01)00884838085282(21)391, (01)00884838085282(21)98, (01)00884838085282(21)441, (01)00884838085282(21)320, (01)00884838085282(21)494, (01)00884838085282(21)65, (01)00884838085282(21)87, (01)00884838085282(21)109, (01)00884838085282(21)75, (01)00884838085282(21)46, (01)00884838085282(21)101, (01)00884838085282(21)311, (01)00884838085282(21)442, (01)00884838085282(21)485, (01)00884838085282(21)121, (01)00884838085282(21)68, (01)00884838085282(21)384, (01)00884838085282(21)91, (01)00884838085282(21)252, (01)00884838085282(21)74, (01)00884838085282(21)73, (01)00884838085282(21)124, (01)00884838085282(21)191, (01)00884838085282(21)122, (01)00884838085282(21)119, (01)00884838085282(21)309, (01)00884838085282(21)400, (01)00884838085282(21)251, (01)00884838085282(21)480, (01)00884838085282(21)387, (01)00884838085282(21)111, (01)00884838085282(21)11, (01)00884838085282(21)147, (01)00884838085282(21)509, (01)00884838085282(21)454, (01)00884838085282(21)478, (01)00884838085282(21)262, (01)00884838085282(21)491, (01)00884838085282(21)133, (01)00884838085282(21)476, (01)00884838085282(21)337, (01)00884838085282(21)275, (01)00884838085282(21)468, (01)00884838085282(21)412, (01)00884838085282(21)508, (01)00884838085282(21)414, (01)00884838085282(21)405, (01)00884838085282(21)396, (01)00884838085282(21)247, (01)00884838085282(21)310, (01)00884838085282(21)517, (01)00884838085282(21)394, (01)00884838085282(21)432, (01)00884838085282(21)504, (01)00884838085282(21)426, (01)00884838085282(21)304, (01)00884838085282(21)469, (01)00884838085282(21)340, (01)00884838085282(21)393, (01)00884838085282(21)343, (01)00884838085282(21)458, (01)00884838085282(21)322, (01)00884838085282(21)444, (01)00884838085282(21)395, (01)00884838085282(21)385, (01)00884838085282(21)505, (01)00884838085282(21)472, (01)00884838085282(21)514, (01)00884838085282(21)236, (01)00884838085282(21)471, (01)00884838085282(21)401, (01)00884838085282(21)234, (01)00884838085282(21)503, (01)00884838085282(21)407, (01)00884838085282(21)470, (01)00884838085282(21)498, (01)00884838085282(21)413, (01)00884838085282(21)440, (01)00884838085282(21)463, (01)00884838085282(21)330, (01)00884838085282(21)475, (01)00884838085282(21)473, (01)00884838085282(21)501, (01)00884838085282(21)308, (01)00884838085282(21)225, (01)00884838085282(21)483, (01)00884838085282(21)474, (01)00884838085282(21)344, (01)00884838085282(21)389, (01)00884838085282(21)492, (01)00884838085282(21)324, (01)00884838085282(21)265, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)496, (01)00884838085282(21)427, (01)00884838085282(21)341, (01)00884838085282(21)100, (01)00884838085282(21)123, (01)00884838085282(21)177, (01)00884838085282(21)250, (01)00884838085282(21)174, (01)00884838085282(21)452, (01)00884838085282(21)168, (01)00884838085282(21)447, (01)00884838085282(21)182, (01)00884838085282(21)198, (01)00884838085282(21)206, (01)00884838085282(21)312, (01)00884838085282(21)403, (01)00884838085282(21)386, (01)00884838085282(21)397, (01)00884838085282(21)500, (01)00884838085282(21)226, (01)00884838085282(21)408, (01)00884838085282(21)43, (01)00884838085282(21)381, (01)00884838085282(21)488, (01)00884838085282(21)416, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)404, (01)00884838085282(21)285, (01)00884838085282(21)515, (01)00884838085282(21)449, (01)00884838085282(21)477, (01)00884838085282(21)338, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)114, (01)00884838085282(21)144, (01)00884838085282(21)327, (01)00884838085282(21)227, (01)00884838085282(21)295, (01)00884838085282(21)294, (01)00884838085282(21)319, (01)00884838085282(21)241, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)284, (01)00884838085282(21)175, (01)00884838085282(21)419, (01)00884838085282(21)372, (01)00884838085282(21)429, (01)00884838085282(21)296, (01)00884838085282(21)172, (01)00884838085282(21)283, (01)00884838085282(21)357, (01)00884838085282(21)306, (01)00884838085282(21)437, (01)00884838085282(21)210, (01)00884838085282(21)315, (01)00884838085282(21)134, (01)00884838085282(21)255, (01)00884838085282(21)207, (01)00884838085282(21)192, (01)00884838085282(21)116, (01)00884838085282(21)221, (01)00884838085282(21)189, (01)00884838085282(21)117, (01)00884838085282(21)313, (01)00884838085282(21)187, (01)00884838085282(21)166, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)108. Serial Numbers: 258, 229, 291, 64, 218, 335, 161, 169, 297, 479, 190, 268, 220, 375, 173, 359, 256, 290, 502, 130, 157, 264, 60, 263, 253, 254, 280, 9, 102, 467, 421, 510, 345, 212, 266, 180, 185, 193, 214, 271, 213, 431, 246, 354, 374, 106, 58, 231, 287, 44, 176, 149, 197, 289, 288, 150, 233, 230, 380, 448, 82, 323, 35, 55, 278, 66, 45, 40, 125, 484, 36, 104, 155, 422, 132, 67, 183, 439, 446, 138, 321, 293, 292, 379, 151, 237, 5, 520, 519, 208, 462, 342, 57, 222, 391, 98, 441, 320, 494, 65, 87, 109, 75, 46, 101, 311, 442, 485, 121, 68, 384, 91, 252, 74, 73, 124, 191, 122, 119, 309, 400, 251, 480, 387, 111, 11, 147, 509, 454, 478, 262, 491, 133, 476, 337, 275, 468, 412, 508, 414, 405, 396, 247, 310, 517, 394, 432, 504, 426, 304, 469, 340, 393, 343, 458, 322, 444, 395, 385, 505, 472, 514, 236, 471, 401, 234, 503, 407, 470, 498, 413, 440, 463, 330, 475, 473, 501, 308, 225, 483, 474, 344, 389, 492, 324, 265, 235, 120, 496, 427, 341, 100, 123, 177, 250, 174, 452, 168, 447, 182, 198, 206, 312, 403, 386, 397, 500, 226, 408, 43, 381, 488, 416, 80, 12, 404, 285, 515, 449, 477, 338, 215, 164, 114, 144, 327, 227, 295, 294, 319, 241, 126, 92, 284, 175, 419, 372, 429, 296, 172, 283, 357, 306, 437, 210, 315, 134, 255, 207, 192, 116, 221, 189, 117, 313, 187, 166, 96, 135, 108. 2. Model Number: 722222. UDI Numbers: (01)00884838099210(21)226, (01)00884838099210(21)55, (01)00884838099210(21)44, (01)00884838099210(21)262, (01)00884838099210(21)37, (01)00884838099210(21)318, (01)00884838099210(21)395, (01)00884838099210(21)269, (01)00884838099210(21)304, (01)00884838099210(21)316, (01)00884838099210(21)307, (01)00884838099210(21)320, (01)00884838099210(21)344, (01)00884838099210(21)343, (01)00884838099210(21)230, (01)00884838099210(21)340, (01)00884838099210(21)346, (01)00884838099210(21)174, (01)00884838099210(21)338, (01)00884838099210(21)345, (01)00884838099210(21)362, (01)00884838099210(21)323, (01)00884838099210(21)336, (01)00884838099210(21)339, (01)00884838099210(21)308, (01)00884838099210(21)182, (01)00884838099210(21)390, (01)00884838099210(21)56, (01)00884838099210(21)312, (01)00884838099210(21)368, (01)00884838099210(21)172, (01)00884838099210(21)151, (01)00884838099210(21)138, (01)00884838099210(21)141, (01)00884838099210(21)384, (01)00884838099210(21)224, (01)00884838099210(21)386, (01)00884838099210(21)383, (01)00884838099210(21)351, (01)00884838099210(21)88, (01)00884838099210(21)210, (01)00884838099210(21)372, (01)00884838099210(21)89, (01)00884838099210(21)373, (01)00884838099210(21)361, (01)00884838099210(21)102, (01)00884838099210(21)118, (01)00884838099210(21)119, (01)00884838099210(21)209, (01)00884838099210(21)331, (01)00884838099210(21)145, (01)00884838099210(21)108, (01)00884838099210(21)48, (01)00884838099210(21)4, (01)00884838099210(21)305, (01)00884838099210(21)80, (01)00884838099210(21)83, (01)00884838099210(21)47, (01)00884838099210(21)222, (01)00884838099210(21)389, (01)00884838099210(21)134, (01)00884838099210(21)369, (01)00884838099210(21)266, (01)00884838099210(21)245, (01)00884838099210(21)335, (01)00884838099210(21)11, (01)00884838099210(21)66, (01)00884838099210(21)50, (01)00884838099210(21)353, (01)00884838099210(21)278, (01)00884838099210(21)82, (01)00884838099210(21)76, (01)00884838099210(21)319, (01)00884838099210(21)106, (01)00884838099210(21)287, (01)00884838099210(21)178, (01)00884838099210(21)117, (01)00884838099210(21)213, (01)00884838099210(21)215, (01)00884838099210(21)104, (01)00884838099210(21)142, (01)00884838099210(21)105, (01)00884838099210(21)251, (01)00884838099210(21)252, (01)00884838099210(21)250, (01)00884838099210(21)183, (01)00884838099210(21)375, (01)00884838099210(21)228, (01)00884838099210(21)322, (01)00884838099210(21)189, (01)00884838099210(21)364, (01)00884838099210(21)333, (01)00884838099210(21)190, (01)00884838099210(21)169, (01)00884838099210(21)219, (01)00884838099210(21)282, (01)00884838099210(21)225, (01)00884838099210(21)166, (01)00884838099210(21)161, (01)00884838099210(21)16, (01)00884838099210(21)396, (01)00884838099210(21)370, (01)00884838099210(21)374, (01)00884838099210(21)115, (01)00884838099210(21)54, (01)00884838099210(21)173, (01)00884838099210(21)90, (01)00884838099210(21)13, (01)00884838099210(21)288, (01)00884838099210(21)289, (01)00884838099210(21)294, (01)00884838099210(21)291, (01)00884838099210(21)292, (01)00884838099210(21)290, (01)00884838099210(21)295, (01)00884838099210(21)186, (01)00884838099210(21)181, (01)00884838099210(21)315, (01)00884838099210(21)354, (01)00884838099210(21)184, (01)00884838099210(21)180, (01)00884838099210(21)284, (01)00884838099210(21)214, (01)00884838099210(21)276, (01)00884838099210(21)116, (01)00884838099210(21)73, (01)00884838099210(21)157, (01)00884838099210(21)135, (01)00884838099210(21)159, (01)00884838099210(21)158, (01)00884838099210(21)78, (01)00884838099210(21)125, (01)00884838099210(21)218, (01)00884838099210(21)126. Serial Numbers: 226, 55, 44, 262, 37, 318, 395, 269, 304, 316, 307, 320, 344, 343, 230, 340, 346, 174, 338, 345, 362, 323, 336, 339, 308, 182, 390, 56, 312, 368, 172, 151, 138, 141, 384, 224, 386, 383, 351, 88, 210, 372, 89, 373, 361, 102, 118, 119, 209, 331, 145, 108, 48, 4, 305, 80, 83, 47, 222, 389, 134, 369, 266, 245, 335, 11, 66, 50, 353, 278, 82, 76, 319, 106, 287, 178, 117, 213, 215, 104, 142, 105, 251, 252, 250, 183, 375, 228, 322, 189, 364, 333, 190, 169, 219, 282, 225, 166, 161, 16, 396, 370, 374, 115, 54, 173, 90, 13, 288, 289, 294, 291, 292, 290, 295, 186, 181, 315, 354, 184, 180, 284, 214, 276, 116, 73, 157, 135, 159, 158, 78, 125, 218, 126. 3. Model Number: 722280. UDI Numbers: (01)00884838103276(21)43, (01)00884838103276(21)179, (01)00884838103276(21)229, (01)00884838103276(21)249, (01)00884838103276(21)65, (01)00884838103276(21)76, (01)00884838103276(21)232, (01)00884838103276(21)113, (01)00884838103276(21)167, (01)00884838103276(21)290, (01)00884838103276(21)165, (01)00884838103276(21)80, (01)00884838103276(21)128, (01)00884838103276(21)278, (01)00884838103276(21)44, (01)00884838103276(21)240, (01)00884838103276(21)246, (01)00884838103276(21)295, (01)00884838103276(21)66, (01)00884838103276(21)175, (01)00884838103276(21)34, (01)00884838103276(21)79, (01)00884838103276(21)130, (01)00884838103276(21)48, (01)00884838103276(21)52, (01)00884838103276(21)141, (01)00884838103276(21)131, (01)00884838103276(21)189, (01)00884838103276(21)223, (01)00884838103276(21)87, (01)00884838103276(21)139, (01)00884838103276(21)259, (01)00884838103276(21)218, (01)00884838103276(21)188, (01)00884838103276(21)30, (01)00884838103276(21)96, (01)00884838103276(21)171, (01)00884838103276(21)118, (01)00884838103276(21)280, (01)00884838103276(21)21, (01)00884838103276(21)284, (01)00884838103276(21)220, (01)00884838103276(21)133, (01)00884838103276(21)38, (01)00884838103276(21)243, (01)00884838103276(21)69, (01)00884838103276(21)210, (01)00884838103276(21)127, (01)00884838103276(21)222, (01)00884838103276(21)144, (01)00884838103276(21)142, (01)00884838103276(21)143, (01)00884838103276(21)198, (01)00884838103276(21)253, (01)00884838103276(21)71, (01)00884838103276(21)241, (01)00884838103276(21)152, (01)00884838103276(21)247, (01)00884838103276(21)17, (01)00884838103276(21)260, (01)00884838103276(21)208, (01)00884838103276(21)46, (01)00884838103276(21)273, (01)00884838103276(21)283, (01)00884838103276(21)235, (01)00884838103276(21)234, (01)00884838103276(21)91, (01)00884838103276(21)277, (01)00884838103276(21)276, (01)00884838103276(21)106, (01)00884838103276(21)258, (01)00884838103276(21)120, (01)00884838103276(21)54, (01)00884838103276(21)216, (01)00884838103276(21)19, (01)00884838103276(21)93, (01)00884838103276(21)24, (01)00884838103276(21)129, (01)00884838103276(21)219, (01)00884838103276(21)88, (01)00884838103276(21)86, (01)00884838103276(21)170, (01)00884838103276(21)102, (01)00884838103276(21)287, (01)00884838103276(21)39, (01)00884838103276(21)99, (01)00884838103276(21)47, (01)00884838103276(21)101, (01)00884838103276(21)42, (01)00884838103276(21)33, (01)00884838103276(21)250, (01)00884838103276(21)239, (01)00884838103276(21)248, (01)00884838103276(21)108, (01)00884838103276(21)119, (01)00884838103276(21)205, (01)00884838103276(21)63, (01)00884838103276(21)261, (01)00884838103276(21)255, (01)00884838103276(21)212, (01)00884838103276(21)84, (01)00884838103276(21)145, (01)00884838103276(21)221, (01)00884838103276(21)36, (01)00884838103276(21)59, (01)00884838103276(21)196, (01)00884838103276(21)110, (01)00884838103276(21)199, (01)00884838103276(21)264, (01)00884838103276(21)140, (01)00884838103276(21)68, (01)00884838103276(21)117, (01)00884838103276(21)257, (01)00884838103276(21)286, (01)00884838103276(21)60, (01)00884838103276(21)103, (01)00884838103276(21)160, (01)00884838103276(21)81, (01)00884838103276(21)114, (01)00884838103276(21)137, (01)00884838103276(21)58, (01)00884838103276(21)35, (01)00884838103276(21)83, (01)00884838103276(21)22, (01)00884838103276(21)94. Serial Numbers: 43, 179, 229, 249, 65, 76, 232, 113, 167, 290, 165, 80, 128, 278, 44, 240, 246, 295, 66, 175, 34, 79, 130, 48, 52, 141, 131, 189, 223, 87, 139, 259, 218, 188, 30, 96, 171, 118, 280, 21, 284, 220, 133, 38, 243, 69, 210, 127, 222, 144, 142, 143, 198, 253, 71, 241, 152, 247, 17, 260, 208, 46, 273, 283, 235, 234, 91, 277, 276, 106, 258, 120, 54, 216, 19, 93, 24, 129, 219, 88, 86, 170, 102, 287, 39, 99, 47, 101, 42, 33, 250, 239, 248, 108, 119, 205, 63, 261, 255, 212, 84, 145, 221, 36, 59, 196, 110, 199, 264, 140, 68, 117, 257, 286, 60, 103, 160, 81, 114, 137, 58, 35, 83, 22, 94.
Quantity recalled519 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0293-2027
FDA event ID
99939
Recalling firm
Philips Medical Systems Nederl, Best
Classification
Class II
Status
Ongoing
Recall initiated
6 Oct 2026
FDA classified
27 Oct 2026
Reported
4 Nov 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

6 Oct 2026Recall initiated by company
27 Oct 2026Classified by FDA+21 days
4 Nov 2026Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

Product as listed by the FDA

Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, 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, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.

Nationwide

Questions about this recall

Why was it recalled?

Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

Which lots are affected?

1. Model Number: 722064. UDI Numbers: (01)00884838085282(21)258, (01)00884838085282(21)229, (01)00884838085282(21)291, (01)00884838085282(21)64, (01)00884838085282(21)218, (01)00884838085282(21)335, (01)00884838085282(21)161, (01)00884838085282(21)169, (01)00884838085282(21)297, (01)00884838085282(21)479, (01)00884838085282(21)190, (01)00884838085282(21)268, (01)00884838085282(21)220, (01)00884838085282(21)375, (01)00884838085282(21)173, (01)00884838085282(21)359, (01)00884838085282(21)256, (01)00884838085282(21)290, (01)00884838085282(21)502, (01)00884838085282(21)130, (01)00884838085282(21)157, (01)00884838085282(21)264, (01)00884838085282(21)60, (01)00884838085282(21)263, (01)00884838085282(21)253, (01)00884838085282(21)254, (01)00884838085282(21)280, (01)00884838085282(21)9, (01)00884838085282(21)102, (01)00884838085282(21)467, (01)00884838085282(21)421, (01)00884838085282(21)510, (01)00884838085282(21)345, (01)00884838085282(21)212, (01)00884838085282(21)266, (01)00884838085282(21)180, 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(01)00884838085282(21)504, (01)00884838085282(21)426, (01)00884838085282(21)304, (01)00884838085282(21)469, (01)00884838085282(21)340, (01)00884838085282(21)393, (01)00884838085282(21)343, (01)00884838085282(21)458, (01)00884838085282(21)322, (01)00884838085282(21)444, (01)00884838085282(21)395, (01)00884838085282(21)385, (01)00884838085282(21)505, (01)00884838085282(21)472, (01)00884838085282(21)514, (01)00884838085282(21)236, (01)00884838085282(21)471, (01)00884838085282(21)401, (01)00884838085282(21)234, (01)00884838085282(21)503, (01)00884838085282(21)407, (01)00884838085282(21)470, (01)00884838085282(21)498, (01)00884838085282(21)413, (01)00884838085282(21)440, (01)00884838085282(21)463, (01)00884838085282(21)330, (01)00884838085282(21)475, (01)00884838085282(21)473, (01)00884838085282(21)501, (01)00884838085282(21)308, (01)00884838085282(21)225, (01)00884838085282(21)483, (01)00884838085282(21)474, (01)00884838085282(21)344, (01)00884838085282(21)389, (01)00884838085282(21)492, (01)00884838085282(21)324, (01)00884838085282(21)265, (01)00884838085282(21)235, (01)00884838085282(21)120, (01)00884838085282(21)496, (01)00884838085282(21)427, (01)00884838085282(21)341, (01)00884838085282(21)100, (01)00884838085282(21)123, (01)00884838085282(21)177, (01)00884838085282(21)250, (01)00884838085282(21)174, (01)00884838085282(21)452, (01)00884838085282(21)168, (01)00884838085282(21)447, (01)00884838085282(21)182, (01)00884838085282(21)198, (01)00884838085282(21)206, (01)00884838085282(21)312, (01)00884838085282(21)403, (01)00884838085282(21)386, (01)00884838085282(21)397, (01)00884838085282(21)500, (01)00884838085282(21)226, (01)00884838085282(21)408, (01)00884838085282(21)43, (01)00884838085282(21)381, (01)00884838085282(21)488, (01)00884838085282(21)416, (01)00884838085282(21)80, (01)00884838085282(21)12, (01)00884838085282(21)404, (01)00884838085282(21)285, (01)00884838085282(21)515, (01)00884838085282(21)449, (01)00884838085282(21)477, (01)00884838085282(21)338, (01)00884838085282(21)215, (01)00884838085282(21)164, (01)00884838085282(21)114, (01)00884838085282(21)144, (01)00884838085282(21)327, (01)00884838085282(21)227, (01)00884838085282(21)295, (01)00884838085282(21)294, (01)00884838085282(21)319, (01)00884838085282(21)241, (01)00884838085282(21)126, (01)00884838085282(21)92, (01)00884838085282(21)284, (01)00884838085282(21)175, (01)00884838085282(21)419, (01)00884838085282(21)372, (01)00884838085282(21)429, (01)00884838085282(21)296, (01)00884838085282(21)172, (01)00884838085282(21)283, (01)00884838085282(21)357, (01)00884838085282(21)306, (01)00884838085282(21)437, (01)00884838085282(21)210, (01)00884838085282(21)315, (01)00884838085282(21)134, (01)00884838085282(21)255, (01)00884838085282(21)207, (01)00884838085282(21)192, (01)00884838085282(21)116, (01)00884838085282(21)221, (01)00884838085282(21)189, (01)00884838085282(21)117, (01)00884838085282(21)313, (01)00884838085282(21)187, (01)00884838085282(21)166, (01)00884838085282(21)96, (01)00884838085282(21)135, (01)00884838085282(21)108. Serial Numbers: 258, 229, 291, 64, 218, 335, 161, 169, 297, 479, 190, 268, 220, 375, 173, 359, 256, 290, 502, 130, 157, 264, 60, 263, 253, 254, 280, 9, 102, 467, 421, 510, 345, 212, 266, 180, 185, 193, 214, 271, 213, 431, 246, 354, 374, 106, 58, 231, 287, 44, 176, 149, 197, 289, 288, 150, 233, 230, 380, 448, 82, 323, 35, 55, 278, 66, 45, 40, 125, 484, 36, 104, 155, 422, 132, 67, 183, 439, 446, 138, 321, 293, 292, 379, 151, 237, 5, 520, 519, 208, 462, 342, 57, 222, 391, 98, 441, 320, 494, 65, 87, 109, 75, 46, 101, 311, 442, 485, 121, 68, 384, 91, 252, 74, 73, 124, 191, 122, 119, 309, 400, 251, 480, 387, 111, 11, 147, 509, 454, 478, 262, 491, 133, 476, 337, 275, 468, 412, 508, 414, 405, 396, 247, 310, 517, 394, 432, 504, 426, 304, 469, 340, 393, 343, 458, 322, 444, 395, 385, 505, 472, 514, 236, 471, 401, 234, 503, 407, 470, 498, 413, 440, 463, 330, 475, 473, 501, 308, 225, 483, 474, 344, 389, 492, 324, 265, 235, 120, 496, 427, 341, 100, 123, 177, 250, 174, 452, 168, 447, 182, 198, 206, 312, 403, 386, 397, 500, 226, 408, 43, 381, 488, 416, 80, 12, 404, 285, 515, 449, 477, 338, 215, 164, 114, 144, 327, 227, 295, 294, 319, 241, 126, 92, 284, 175, 419, 372, 429, 296, 172, 283, 357, 306, 437, 210, 315, 134, 255, 207, 192, 116, 221, 189, 117, 313, 187, 166, 96, 135, 108. 2. Model Number: 722222. UDI Numbers: (01)00884838099210(21)226, (01)00884838099210(21)55, (01)00884838099210(21)44, (01)00884838099210(21)262, (01)00884838099210(21)37, (01)00884838099210(21)318, (01)00884838099210(21)395, (01)00884838099210(21)269, (01)00884838099210(21)304, (01)00884838099210(21)316, (01)00884838099210(21)307, (01)00884838099210(21)320, (01)00884838099210(21)344, (01)00884838099210(21)343, (01)00884838099210(21)230, (01)00884838099210(21)340, (01)00884838099210(21)346, (01)00884838099210(21)174, (01)00884838099210(21)338, (01)00884838099210(21)345, (01)00884838099210(21)362, (01)00884838099210(21)323, (01)00884838099210(21)336, (01)00884838099210(21)339, (01)00884838099210(21)308, (01)00884838099210(21)182, (01)00884838099210(21)390, (01)00884838099210(21)56, (01)00884838099210(21)312, (01)00884838099210(21)368, (01)00884838099210(21)172, (01)00884838099210(21)151, (01)00884838099210(21)138, (01)00884838099210(21)141, (01)00884838099210(21)384, (01)00884838099210(21)224, (01)00884838099210(21)386, (01)00884838099210(21)383, (01)00884838099210(21)351, (01)00884838099210(21)88, (01)00884838099210(21)210, (01)00884838099210(21)372, (01)00884838099210(21)89, (01)00884838099210(21)373, (01)00884838099210(21)361, (01)00884838099210(21)102, (01)00884838099210(21)118, (01)00884838099210(21)119, (01)00884838099210(21)209, (01)00884838099210(21)331, (01)00884838099210(21)145, (01)00884838099210(21)108, (01)00884838099210(21)48, (01)00884838099210(21)4, (01)00884838099210(21)305, (01)00884838099210(21)80, (01)00884838099210(21)83, (01)00884838099210(21)47, (01)00884838099210(21)222, (01)00884838099210(21)389, (01)00884838099210(21)134, (01)00884838099210(21)369, (01)00884838099210(21)266, (01)00884838099210(21)245, (01)00884838099210(21)335, (01)00884838099210(21)11, (01)00884838099210(21)66, (01)00884838099210(21)50, (01)00884838099210(21)353, (01)00884838099210(21)278, (01)00884838099210(21)82, (01)00884838099210(21)76, (01)00884838099210(21)319, (01)00884838099210(21)106, (01)00884838099210(21)287, (01)00884838099210(21)178, (01)00884838099210(21)117, (01)00884838099210(21)213, (01)00884838099210(21)215, (01)00884838099210(21)104, (01)00884838099210(21)142, (01)00884838099210(21)105, (01)00884838099210(21)251, (01)00884838099210(21)252, (01)00884838099210(21)250, (01)00884838099210(21)183, (01)00884838099210(21)375, (01)00884838099210(21)228, (01)00884838099210(21)322, (01)00884838099210(21)189, (01)00884838099210(21)364, (01)00884838099210(21)333, (01)00884838099210(21)190, (01)00884838099210(21)169, (01)00884838099210(21)219, (01)00884838099210(21)282, (01)00884838099210(21)225, (01)00884838099210(21)166, (01)00884838099210(21)161, (01)00884838099210(21)16, (01)00884838099210(21)396, (01)00884838099210(21)370, (01)00884838099210(21)374, (01)00884838099210(21)115, (01)00884838099210(21)54, (01)00884838099210(21)173, (01)00884838099210(21)90, (01)00884838099210(21)13, (01)00884838099210(21)288, (01)00884838099210(21)289, (01)00884838099210(21)294, (01)00884838099210(21)291, (01)00884838099210(21)292, (01)00884838099210(21)290, (01)00884838099210(21)295, (01)00884838099210(21)186, (01)00884838099210(21)181, (01)00884838099210(21)315, (01)00884838099210(21)354, (01)00884838099210(21)184, (01)00884838099210(21)180, (01)00884838099210(21)284, (01)00884838099210(21)214, (01)00884838099210(21)276, (01)00884838099210(21)116, (01)00884838099210(21)73, (01)00884838099210(21)157, (01)00884838099210(21)135, (01)00884838099210(21)159, (01)00884838099210(21)158, (01)00884838099210(21)78, (01)00884838099210(21)125, (01)00884838099210(21)218, (01)00884838099210(21)126. Serial Numbers: 226, 55, 44, 262, 37, 318, 395, 269, 304, 316, 307, 320, 344, 343, 230, 340, 346, 174, 338, 345, 362, 323, 336, 339, 308, 182, 390, 56, 312, 368, 172, 151, 138, 141, 384, 224, 386, 383, 351, 88, 210, 372, 89, 373, 361, 102, 118, 119, 209, 331, 145, 108, 48, 4, 305, 80, 83, 47, 222, 389, 134, 369, 266, 245, 335, 11, 66, 50, 353, 278, 82, 76, 319, 106, 287, 178, 117, 213, 215, 104, 142, 105, 251, 252, 250, 183, 375, 228, 322, 189, 364, 333, 190, 169, 219, 282, 225, 166, 161, 16, 396, 370, 374, 115, 54, 173, 90, 13, 288, 289, 294, 291, 292, 290, 295, 186, 181, 315, 354, 184, 180, 284, 214, 276, 116, 73, 157, 135, 159, 158, 78, 125, 218, 126. 3. Model Number: 722280. UDI Numbers: (01)00884838103276(21)43, (01)00884838103276(21)179, (01)00884838103276(21)229, (01)00884838103276(21)249, (01)00884838103276(21)65, (01)00884838103276(21)76, (01)00884838103276(21)232, (01)00884838103276(21)113, (01)00884838103276(21)167, (01)00884838103276(21)290, (01)00884838103276(21)165, (01)00884838103276(21)80, (01)00884838103276(21)128, (01)00884838103276(21)278, (01)00884838103276(21)44, (01)00884838103276(21)240, (01)00884838103276(21)246, (01)00884838103276(21)295, (01)00884838103276(21)66, (01)00884838103276(21)175, (01)00884838103276(21)34, (01)00884838103276(21)79, (01)00884838103276(21)130, (01)00884838103276(21)48, (01)00884838103276(21)52, (01)00884838103276(21)141, (01)00884838103276(21)131, (01)00884838103276(21)189, (01)00884838103276(21)223, (01)00884838103276(21)87, (01)00884838103276(21)139, (01)00884838103276(21)259, (01)00884838103276(21)218, (01)00884838103276(21)188, (01)00884838103276(21)30, (01)00884838103276(21)96, (01)00884838103276(21)171, (01)00884838103276(21)118, (01)00884838103276(21)280, (01)00884838103276(21)21, (01)00884838103276(21)284, (01)00884838103276(21)220, (01)00884838103276(21)133, (01)00884838103276(21)38, (01)00884838103276(21)243, (01)00884838103276(21)69, (01)00884838103276(21)210, (01)00884838103276(21)127, (01)00884838103276(21)222, (01)00884838103276(21)144, (01)00884838103276(21)142, (01)00884838103276(21)143, (01)00884838103276(21)198, (01)00884838103276(21)253, (01)00884838103276(21)71, (01)00884838103276(21)241, (01)00884838103276(21)152, (01)00884838103276(21)247, (01)00884838103276(21)17, (01)00884838103276(21)260, (01)00884838103276(21)208, (01)00884838103276(21)46, (01)00884838103276(21)273, (01)00884838103276(21)283, (01)00884838103276(21)235, (01)00884838103276(21)234, (01)00884838103276(21)91, (01)00884838103276(21)277, (01)00884838103276(21)276, (01)00884838103276(21)106, (01)00884838103276(21)258, (01)00884838103276(21)120, (01)00884838103276(21)54, (01)00884838103276(21)216, (01)00884838103276(21)19, (01)00884838103276(21)93, (01)00884838103276(21)24, (01)00884838103276(21)129, (01)00884838103276(21)219, (01)00884838103276(21)88, (01)00884838103276(21)86, (01)00884838103276(21)170, (01)00884838103276(21)102, (01)00884838103276(21)287, (01)00884838103276(21)39, (01)00884838103276(21)99, (01)00884838103276(21)47, (01)00884838103276(21)101, (01)00884838103276(21)42, (01)00884838103276(21)33, (01)00884838103276(21)250, (01)00884838103276(21)239, (01)00884838103276(21)248, (01)00884838103276(21)108, (01)00884838103276(21)119, (01)00884838103276(21)205, (01)00884838103276(21)63, (01)00884838103276(21)261, (01)00884838103276(21)255, (01)00884838103276(21)212, (01)00884838103276(21)84, (01)00884838103276(21)145, (01)00884838103276(21)221, (01)00884838103276(21)36, (01)00884838103276(21)59, (01)00884838103276(21)196, (01)00884838103276(21)110, (01)00884838103276(21)199, (01)00884838103276(21)264, (01)00884838103276(21)140, (01)00884838103276(21)68, (01)00884838103276(21)117, (01)00884838103276(21)257, (01)00884838103276(21)286, (01)00884838103276(21)60, (01)00884838103276(21)103, (01)00884838103276(21)160, (01)00884838103276(21)81, (01)00884838103276(21)114, (01)00884838103276(21)137, (01)00884838103276(21)58, (01)00884838103276(21)35, (01)00884838103276(21)83, (01)00884838103276(21)22, (01)00884838103276(21)94. Serial Numbers: 43, 179, 229, 249, 65, 76, 232, 113, 167, 290, 165, 80, 128, 278, 44, 240, 246, 295, 66, 175, 34, 79, 130, 48, 52, 141, 131, 189, 223, 87, 139, 259, 218, 188, 30, 96, 171, 118, 280, 21, 284, 220, 133, 38, 243, 69, 210, 127, 222, 144, 142, 143, 198, 253, 71, 241, 152, 247, 17, 260, 208, 46, 273, 283, 235, 234, 91, 277, 276, 106, 258, 120, 54, 216, 19, 93, 24, 129, 219, 88, 86, 170, 102, 287, 39, 99, 47, 101, 42, 33, 250, 239, 248, 108, 119, 205, 63, 261, 255, 212, 84, 145, 221, 36, 59, 196, 110, 199, 264, 140, 68, 117, 257, 286, 60, 103, 160, 81, 114, 137, 58, 35, 83, 22, 94.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, 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, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 10 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 99939

This product is part of a recall event; the main page for the event is Philips Azurion 5 M12 recalled by Philips Medical Systems Nederl.

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