FDA Medical Device · Z-0295-2027

Philips Azurion 5 M20. Model Numbers: 722228, 722281.

Class II · Ongoing

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.

Affected lots / codes — check yours against this1. Model Number: 722228. UDI Numbers: (01)00884838099234(21)49, (01)00884838099234(21)159, (01)00884838099234(21)180, (01)00884838099234(21)273, (01)00884838099234(21)132, (01)00884838099234(21)533, (01)00884838099234(21)47, (01)00884838099234(21)522, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)431, (01)00884838099234(21)113, (01)00884838099234(21)529, (01)00884838099234(21)659, (01)00884838099234(21)145, (01)00884838099234(21)567, (01)00884838099234(21)539, (01)00884838099234(21)645, (01)00884838099234(21)308, (01)00884838099234(21)333, (01)00884838099234(21)335, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)44, (01)00884838099234(21)569, (01)00884838099234(21)418, (01)00884838099234(21)280, (01)00884838099234(21)616, (01)00884838099234(21)568, (01)00884838099234(21)471, (01)00884838099234(21)428, (01)00884838099234(21)465, (01)00884838099234(21)102, (01)00884838099234(21)176, (01)00884838099234(21)103, (01)00884838099234(21)178, (01)00884838099234(21)109, (01)00884838099234(21)16, (01)00884838099234(21)234, (01)00884838099234(21)566, (01)00884838099234(21)571, (01)00884838099234(21)463, (01)00884838099234(21)647, (01)00884838099234(21)317, (01)00884838099234(21)562, (01)00884838099234(21)552, (01)00884838099234(21)680, (01)00884838099234(21)724, (01)00884838099234(21)561, (01)00884838099234(21)517, (01)00884838099234(21)203, (01)00884838099234(21)773, (01)00884838099234(21)260, (01)00884838099234(21)107, (01)00884838099234(21)100, (01)00884838099234(21)108, (01)00884838099234(21)640, (01)00884838099234(21)99, (01)00884838099234(21)101, (01)00884838099234(21)318, (01)00884838099234(21)602, (01)00884838099234(21)75, (01)00884838099234(21)78, (01)00884838099234(21)531, (01)00884838099234(21)574, (01)00884838099234(21)370, (01)00884838099234(21)464, (01)00884838099234(21)580, (01)00884838099234(21)496, (01)00884838099234(21)668, (01)00884838099234(21)223, (01)00884838099234(21)312, (01)00884838099234(21)218, (01)00884838099234(21)513, (01)00884838099234(21)442, (01)00884838099234(21)548, (01)00884838099234(21)174, (01)00884838099234(21)486, (01)00884838099234(21)487, (01)00884838099234(21)84, (01)00884838099234(21)346, (01)00884838099234(21)172, (01)00884838099234(21)217, (01)00884838099234(21)575, (01)00884838099234(21)697, (01)00884838099234(21)196, (01)00884838099234(21)676, (01)00884838099234(21)677, (01)00884838099234(21)118, (01)00884838099234(21)415, (01)00884838099234(21)452, (01)00884838099234(21)179, (01)00884838099234(21)331, (01)00884838099234(21)297, (01)00884838099234(21)412, (01)00884838099234(21)427, (01)00884838099234(21)488, (01)00884838099234(21)500, (01)00884838099234(21)588, (01)00884838099234(21)443, (01)00884838099234(21)663, (01)00884838099234(21)747, (01)00884838099234(21)754, (01)00884838099234(21)621, (01)00884838099234(21)766, (01)00884838099234(21)90, (01)00884838099234(21)739, (01)00884838099234(21)498, (01)00884838099234(21)743, (01)00884838099234(21)707, (01)00884838099234(21)738, (01)00884838099234(21)755, (01)00884838099234(21)708, (01)00884838099234(21)284, (01)00884838099234(21)742, (01)00884838099234(21)725, (01)00884838099234(21)565, (01)00884838099234(21)745, (01)00884838099234(21)201, (01)00884838099234(21)457, (01)00884838099234(21)458, (01)00884838099234(21)690, (01)00884838099234(21)46, (01)00884838099234(21)171, (01)00884838099234(21)34, (01)00884838099234(21)229, (01)00884838099234(21)332, (01)00884838099234(21)306, (01)00884838099234(21)610, (01)00884838099234(21)646, (01)00884838099234(21)429, (01)00884838099234(21)56, (01)00884838099234(21)601, (01)00884838099234(21)257, (01)00884838099234(21)608, (01)00884838099234(21)763, (01)00884838099234(21)590, (01)00884838099234(21)591, (01)00884838099234(21)628, (01)00884838099234(21)197, (01)00884838099234(21)366, (01)00884838099234(21)345, (01)00884838099234(21)627, (01)00884838099234(21)302, (01)00884838099234(21)166, (01)00884838099234(21)432, (01)00884838099234(21)356, (01)00884838099234(21)357, (01)00884838099234(21)305, (01)00884838099234(21)620, (01)00884838099234(21)220, (01)00884838099234(21)325, (01)00884838099234(21)545, (01)00884838099234(21)405, (01)00884838099234(21)514, (01)00884838099234(21)341, (01)00884838099234(21)342, (01)00884838099234(21)184, (01)00884838099234(21)426, (01)00884838099234(21)497, (01)00884838099234(21)183, (01)00884838099234(21)195, (01)00884838099234(21)282, (01)00884838099234(21)490, (01)00884838099234(21)421, (01)00884838099234(21)440, (01)00884838099234(21)446, (01)00884838099234(21)320, (01)00884838099234(21)281, (01)00884838099234(21)480, (01)00884838099234(21)364, (01)00884838099234(21)448, (01)00884838099234(21)283, (01)00884838099234(21)473, (01)00884838099234(21)321, (01)00884838099234(21)476, (01)00884838099234(21)681, (01)00884838099234(21)409, (01)00884838099234(21)535, (01)00884838099234(21)519, (01)00884838099234(21)384, (01)00884838099234(21)489, (01)00884838099234(21)361, (01)00884838099234(21)787, (01)00884838099234(21)303, (01)00884838099234(21)413, (01)00884838099234(21)785, (01)00884838099234(21)765, (01)00884838099234(21)512, (01)00884838099234(21)437, (01)00884838099234(21)656, (01)00884838099234(21)336, (01)00884838099234(21)200, (01)00884838099234(21)504, (01)00884838099234(21)94, (01)00884838099234(21)494, (01)00884838099234(21)667, (01)00884838099234(21)408, (01)00884838099234(21)532, (01)00884838099234(21)698, (01)00884838099234(21)449, (01)00884838099234(21)438, (01)00884838099234(21)453, (01)00884838099234(21)106, (01)00884838099234(21)311, (01)00884838099234(21)459, (01)00884838099234(21)477, (01)00884838099234(21)330, (01)00884838099234(21)167, (01)00884838099234(21)549, (01)00884838099234(21)784, (01)00884838099234(21)390, (01)00884838099234(21)261, (01)00884838099234(21)334, (01)00884838099234(21)337, (01)00884838099234(21)467, (01)00884838099234(21)304, (01)00884838099234(21)212, (01)00884838099234(21)340, (01)00884838099234(21)515, (01)00884838099234(21)173, (01)00884838099234(21)219, (01)00884838099234(21)160, (01)00884838099234(21)634, (01)00884838099234(21)82, (01)00884838099234(21)732, (01)00884838099234(21)133, (01)00884838099234(21)733, (01)00884838099234(21)208, (01)00884838099234(21)165, (01)00884838099234(21)378, (01)00884838099234(21)685, (01)00884838099234(21)164, (01)00884838099234(21)228, (01)00884838099234(21)701, (01)00884838099234(21)401, (01)00884838099234(21)161, (01)00884838099234(21)147, (01)00884838099234(21)723, (01)00884838099234(21)691, (01)00884838099234(21)730, (01)00884838099234(21)146, (01)00884838099234(21)170, (01)00884838099234(21)295, (01)00884838099234(21)290, (01)00884838099234(21)316, (01)00884838099234(21)207, (01)00884838099234(21)686, (01)00884838099234(21)119. Serial Numbers: 49, 159, 180, 273, 132, 533, 47, 522, 32, 23, 25, 62, 48, 153, 431, 113, 529, 659, 145, 567, 539, 645, 308, 333, 335, 570, 560, 44, 569, 418, 280, 616, 568, 471, 428, 465, 102, 176, 103, 178, 109, 16, 234, 566, 571, 463, 647, 317, 562, 552, 680, 724, 561, 517, 203, 773, 260, 107, 100, 108, 640, 99, 101, 318, 602, 75, 78, 531, 574, 370, 464, 580, 496, 668, 223, 312, 218, 513, 442, 548, 174, 486, 487, 84, 346, 172, 217, 575, 697, 196, 676, 677, 118, 415, 452, 179, 331, 297, 412, 427, 488, 500, 588, 443, 663, 747, 754, 621, 766, 90, 739, 498, 743, 707, 738, 755, 708, 284, 742, 725, 565, 745, 201, 457, 458, 690, 46, 171, 34, 229, 332, 306, 610, 646, 429, 56, 601, 257, 608, 763, 590, 591, 628, 197, 366, 345, 627, 302, 166, 432, 356, 357, 305, 620, 220, 325, 545, 405, 514, 341, 342, 184, 426, 497, 183, 195, 282, 490, 421, 440, 446, 320, 281, 480, 364, 448, 283, 473, 321, 476, 681, 409, 535, 519, 384, 489, 361, 787, 303, 413, 785, 765, 512, 437, 656, 336, 200, 504, 94, 494, 667, 408, 532, 698, 449, 438, 453, 106, 311, 459, 477, 330, 167, 549, 784, 390, 261, 334, 337, 467, 304, 212, 340, 515, 173, 219, 160, 634, 82, 732, 133, 733, 208, 165, 378, 685, 164, 228, 701, 401, 161, 147, 723, 691, 730, 146, 170, 295, 290, 316, 207, 686, 119. 2. Model Number: 722281. UDI Numbers: (01)00884838110564(21)379, (01)00884838110564(21)233, (01)00884838110564(21)391, (01)00884838110564(21)334, (01)00884838110564(21)55, (01)00884838110564(21)37, (01)00884838110564(21)21, (01)00884838110564(21)496, (01)00884838110564(21)278, (01)00884838110564(21)467, (01)00884838110564(21)390, (01)00884838110564(21)27, (01)00884838110564(21)366, (01)00884838110564(21)140, (01)00884838110564(21)60, (01)00884838110564(21)487, (01)00884838110564(21)341, (01)00884838110564(21)338, (01)00884838110564(21)108, (01)00884838110564(21)24, (01)00884838110564(21)306, (01)00884838110564(21)328, (01)00884838110564(21)129, (01)00884838110564(21)417, (01)00884838110564(21)457, (01)00884838110564(21)521, (01)00884838110564(21)356, (01)00884838110564(21)428, (01)00884838110564(21)66, (01)00884838110564(21)145, (01)00884838110564(21)401, (01)00884838110564(21)402, (01)00884838110564(21)488, (01)00884838110564(21)444, (01)00884838110564(21)431, (01)00884838110564(21)115, (01)00884838110564(21)446, (01)00884838110564(21)17, (01)00884838110564(21)517, (01)00884838110564(21)12, (01)00884838110564(21)65, (01)00884838110564(21)125, (01)00884838110564(21)339, (01)00884838110564(21)351, (01)00884838110564(21)337, (01)00884838110564(21)364, (01)00884838110564(21)210, (01)00884838110564(21)188, (01)00884838110564(21)203, (01)00884838110564(21)476, (01)00884838110564(21)419, (01)00884838110564(21)542, (01)00884838110564(21)295, (01)00884838110564(21)236, (01)00884838110564(21)307, (01)00884838110564(21)350, (01)00884838110564(21)304, (01)00884838110564(21)342, (01)00884838110564(21)410, (01)00884838110564(21)38, (01)00884838110564(21)228, (01)00884838110564(21)19, (01)00884838110564(21)105, (01)00884838110564(21)344, (01)00884838110564(21)80, (01)00884838110564(21)225, (01)00884838110564(21)186, (01)00884838110564(21)352, (01)00884838110564(21)426, (01)00884838110564(21)117, (01)00884838110564(21)500, (01)00884838110564(21)396, (01)00884838110564(21)270, (01)00884838110564(21)11, (01)00884838110564(21)219, (01)00884838110564(21)371, (01)00884838110564(21)157, (01)00884838110564(21)290, (01)00884838110564(21)102, (01)00884838110564(21)389, (01)00884838110564(21)442, (01)00884838110564(21)23, (01)00884838110564(21)9, (01)00884838110564(21)458, (01)00884838110564(21)168, (01)00884838110564(21)204, (01)00884838110564(21)432, (01)00884838110564(21)466, (01)00884838110564(21)463, (01)00884838110564(21)447, (01)00884838110564(21)310, (01)00884838110564(21)35, (01)00884838110564(21)155, (01)00884838110564(21)485, (01)00884838110564(21)468, (01)00884838110564(21)418, (01)00884838110564(21)76, (01)00884838110564(21)430, (01)00884838110564(21)126, (01)00884838110564(21)450, (01)00884838110564(21)365, (01)00884838110564(21)207, (01)00884838110564(21)377, (01)00884838110564(21)85, (01)00884838110564(21)406, (01)00884838110564(21)276, (01)00884838110564(21)327, (01)00884838110564(21)226, (01)00884838110564(21)156, (01)00884838110564(21)170, (01)00884838110564(21)407, (01)00884838110564(21)101, (01)00884838110564(21)229, (01)00884838110564(21)434, (01)00884838110564(21)88, (01)00884838110564(21)291, (01)00884838110564(21)89, (01)00884838110564(21)68, (01)00884838110564(21)221, (01)00884838110564(21)33, (01)00884838110564(21)367, (01)00884838110564(21)289, (01)00884838110564(21)83, (01)00884838110564(21)10, (01)00884838110564(21)363, (01)00884838110564(21)39, (01)00884838110564(21)326, (01)00884838110564(21)331, (01)00884838110564(21)57, (01)00884838110564(21)178, (01)00884838110564(21)323, (01)00884838110564(21)13, (01)00884838110564(21)251, (01)00884838110564(21)477, (01)00884838110564(21)325, (01)00884838110564(21)82, (01)00884838110564(21)222, (01)00884838110564(21)121, (01)00884838110564(21)134, (01)00884838110564(21)510, (01)00884838110564(21)96, (01)00884838110564(21)448, (01)00884838110564(21)75, (01)00884838110564(21)91, (01)00884838110564(21)374, (01)00884838110564(21)414, (01)00884838110564(21)501, (01)00884838110564(21)87, (01)00884838110564(21)49, (01)00884838110564(21)166, (01)00884838110564(21)72, (01)00884838110564(21)531, (01)00884838110564(21)47, (01)00884838110564(21)454, (01)00884838110564(21)242, (01)00884838110564(21)480, (01)00884838110564(21)234, (01)00884838110564(21)197, (01)00884838110564(21)206, (01)00884838110564(21)518, (01)00884838110564(21)519, (01)00884838110564(21)58, (01)00884838110564(21)263, (01)00884838110564(21)193, (01)00884838110564(21)280, (01)00884838110564(21)452, (01)00884838110564(21)118, (01)00884838110564(21)137, (01)00884838110564(21)303, (01)00884838110564(21)439, (01)00884838110564(21)302, (01)00884838110564(21)195, (01)00884838110564(21)103, (01)00884838110564(21)471, (01)00884838110564(21)443, (01)00884838110564(21)196, (01)00884838110564(21)408, (01)00884838110564(21)579, (01)00884838110564(21)29, (01)00884838110564(21)502, (01)00884838110564(21)512, (01)00884838110564(21)163, (01)00884838110564(21)437, (01)00884838110564(21)111, (01)00884838110564(21)368, (01)00884838110564(21)479, (01)00884838110564(21)42, (01)00884838110564(21)412, (01)00884838110564(21)411, (01)00884838110564(21)449, (01)00884838110564(21)184, (01)00884838110564(21)185, (01)00884838110564(21)30, (01)00884838110564(21)31, (01)00884838110564(21)25, (01)00884838110564(21)483, (01)00884838110564(21)106, (01)00884838110564(21)142, (01)00884838110564(21)128, (01)00884838110564(21)504, (01)00884838110564(21)506, (01)00884838110564(21)478, (01)00884838110564(21)505, (01)00884838110564(21)473, (01)00884838110564(21)507, (01)00884838110564(21)16, (01)00884838110564(21)475, (01)00884838110564(21)257, (01)00884838110564(21)262, (01)00884838110564(21)165, (01)00884838110564(21)248, (01)00884838110564(21)288. Serial Numbers: 379, 233, 391, 334, 55, 37, 21, 496, 278, 467, 390, 27, 366, 140, 60, 487, 341, 338, 108, 24, 306, 328, 129, 417, 457, 521, 356, 428, 66, 145, 401, 402, 488, 444, 431, 115, 446, 17, 517, 12, 65, 125, 339, 351, 337, 364, 210, 188, 203, 476, 419, 542, 295, 236, 307, 350, 304, 342, 410, 38, 228, 19, 105, 344, 80, 225, 186, 352, 426, 117, 500, 396, 270, 11, 219, 371, 157, 290, 102, 389, 442, 23, 9, 458, 168, 204, 432, 466, 463, 447, 310, 35, 155, 485, 468, 418, 76, 430, 126, 450, 365, 207, 377, 85, 406, 276, 327, 226, 156, 170, 407, 101, 229, 434, 88, 291, 89, 68, 221, 33, 367, 289, 83, 10, 363, 39, 326, 331, 57, 178, 323, 13, 251, 477, 325, 82, 222, 121, 134, 510, 96, 448, 75, 91, 374, 414, 501, 87, 49, 166, 72, 531, 47, 454, 242, 480, 234, 197, 206, 518, 519, 58, 263, 193, 280, 452, 118, 137, 303, 439, 302, 195, 103, 471, 443, 196, 408, 579, 29, 502, 512, 163, 437, 111, 368, 479, 42, 412, 411, 449, 184, 185, 30, 31, 25, 483, 106, 142, 128, 504, 506, 478, 505, 473, 507, 16, 475, 257, 262, 165, 248, 288.

Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best,
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 465 units
Distribution: 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…
Recall initiated: October 6, 2026
Classified: October 27, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0295-2027%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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