Moderate riskFDA DeviceApr 8, 2026Class II

Philips Azurion 5 M20 X-ray system recalled for intermittent foot switch failure

Philips has identified a problem with the wired foot switch on certain Azurion 5 M20 X-ray imaging systems where the X-ray may not start or may start and stop unexpectedly. This affects 920 systems worldwide, including 168 in the U.S. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

If your facility operates an Azurion 5 M20 system, check the serial number against the affected list
Contact Philips Medical Systems for instructions on a replacement foot switch or system update
Do not rely on the wired foot switch until the issue is resolved

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 22 products — see all of them.

Details

Units affected: 920 units (168 US, 752 OUS)
Illnesses reported: None reported
Manufactured in: Veenpluis 6, Best, Netherlands
Classification: Class II
Recall number: Z-1680-2026

In the FDA's words

Description: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. (1) System Code: 722228; UDI: 00884838099234; System Serial Number: 67, 524, 49, 678, 679, 10, 36, 64, 110, 403, 328, 481, 373, 149, 213, 45, 537, 615, 159, 18, 231, 180, 61, 204, 273, 538, 76, 502, 150, 132, 399, 533, 211, 17, 47, 38, 87, 617, 618, 619, 128, 522, 32, 600, 23, 25, 62, 177, 181, 48, 189, 153, 79, 80, 157, 24, 187, 26, 642, 431, 29, 113, 122, 127, 6, 123, 124, 185, 186, 198, 92, 215, 573, 91, 529, 523, 205, 20, 37, 659, 145, 3, 567, 539, 645, 156, 308, 333, 335, 570, 560, 44, 569, 418, 525, 280, 616, 387, 568, 471, 428, 465, 556, 629, 102, 103, 176, 178, 109, 16, 299, 234, 566, 508, 571, 463, 71, 493, 1, 434, 647, 317, 562, 230, 293, 552, 457, 458, 369, 561, 517, 203, 554, 260, 100, 101, 107, 108, 640, 99, 318, 21, 22, 676, 677, 154, 531, 75, 602, 78, 574, 158, 461, 370, 613, 393, 564, 482, 194, 660, 673, 60, 464, 4, 462, 138, 223, 312, 319, 98, 623, 475, 125, 218, 513, 442, 435, 9, 95, 557, 174, 548, 486, 487, 84, 454, 346, 396, 39, 339, 172, 191, 327, 52, 575, 196, 406, 118, 415, 436, 114, 452, 53, 216, 761, 179, 398, 31, 88, 331, 297, 392, 374, 503, 412, 385, 343, 427, 488, 389, 349, 536, 214, 232, 500, 713, 622, 727, 469, 588, 365, 443, 510, 757, 758, 692, 747, 705, 414, 712, 728, 621, 710, 715, 726, 717, 90, 706, 417, 709, 498, 729, 130, 707, 714, 718, 755, 711, 716, 750, 708, 744, 704, 284, 663, 725, 565, 745, 73, 474, 724, 735, 703, 201, 407, 397, 104, 202, 690, 46, 171, 34, 70, 680, 657, 229, 259, 332, 643, 501, 286, 306, 610, 117, 646, 13, 395, 429, 12, 56, 654, 460, 601, 579, 57, 86, 665, 628, 257, 607, 608, 430, 360, 650, 651, 590, 591, 595, 352, 329, 197, 366, 345, 627, 302, 166, 664, 432, 361, 305, 542, 313, 620, 220, 325, 545, 405, 514, 433, 341, 342, 184, 424, 425, 426, 497, 630, 258, 183, 195, 314, 555, 626, 282, 402, 490, 439, 421, 440, 446, 338, 472, 662, 689, 633, 320, 281, 480, 631, 364, 581, 182, 448, 283, 291, 473, 321, 476, 681, 409, 535, 376, 606, 519, 655, 384, 534, 362, 520, 489, 592, 303, 413, 496, 580, 668, 106, 63, 685, 691, 701, 722, 723, 730, 732, 733, 765, 35, 512, 404, 74, 437, 614, 546, 14, 336, 200, 344, 356, 357, 394, 7, 504, 190, 377, 383, 193, 94, 89, 93, 309, 310, 494, 444, 199, 667, 391, 408, 532, 698, 83, 143, 518, 85, 483, 449, 337, 438, 453, 311, 324, 639, 353, 459, 5, 43, 477, 330, 386, 288, 167, 549, 390, 368, 192, 66, 115, 116, 334, 467, 307, 304, 350, 212, 340, 348, 506, 516, 515, 292, 33, 173, 543, 217, 219, 160, 702, 634, 82, 135, 133, 208, 478, 162, 165, 635, 597, 378, 466, 163, 168, 479, 164, 81, 228, 401, 688, 97, 719, 139, 540, 121, 147, 354, 141, 734, 285, 720, 65, 140, 598, 294, 146, 175, 170, 637, 295, 290, 134, 136, 316, 289, 207, 686, 492, 416, 298, 30, 59, 419, 11, 119, 28, 144, 68, 55, 27, 233, 611; (2) System Code: 722232; UDI: 00884838116757; System Serial Number: 5, 33, 34, 106, 49, 138, 91, 2, 95, 96, 36, 23, 108, 42, 48, 46, 76, 6, 60, 61, 10, 43, 97, 8, 113, 118, 119, 139, 22, 50, 75, 63, 130, 132, 89, 86, 69, 3, 67, 39, 4, 44, 122, 123, 71, 72, 110, 93, 1, 68, 11, 77, 20, 7, 57, 58, 260, 115, 14, 82, 70, 112, 81, 131, 277, 128, 31, 37, 120, 121, 35, 293, 28, 30, 54, 102, 19, 134, 137, 29, 56, 51, 32, 105, 16, 117, 73, 100, 13; (3) System Code: 722281; UDI: 00884838110564; System Serial Number: 125, 176, 233, 296, 74, 284, 55, 81, 37, 21, 135, 278, 390, 179, 181, 182, 282, 286, 357, 358, 359, 109, 136, 93, 153, 247, 27, 28, 299, 76, 140, 60, 341, 310, 192, 275, 127, 108, 254, 255, 24, 20, 129, 343, 295, 215, 66, 98, 48, 235, 378, 145, 336, 115, 348, 120, 17, 12, 65, 217, 339, 351, 95, 364, 236, 308, 44, 45, 319, 164, 124, 159, 317, 318, 64, 189, 71, 38, 387, 228, 272, 54, 19, 26, 105, 344, 259, 260, 261, 316, 80, 265, 70, 190, 225, 186, 180, 281, 202, 349, 149, 117, 388, 52, 175, 187, 270, 11, 219, 371, 269, 157, 290, 102, 244, 94, 110, 23, 9, 208, 209, 168, 204, 114, 253, 35, 155, 199, 201, 161, 126, 211, 287, 207, 85, 321, 227, 276, 226, 169, 156, 258, 170, 415, 294, 101, 229, 146, 14, 88, 99, 188, 89, 273, 340, 68, 151, 141, 221, 33, 307, 350, 289, 246, 83, 10, 177, 39, 40, 43, 326, 331, 57, 212, 304, 122, 178, 367, 323, 69, 191, 50, 13, 61, 194, 200, 250, 251, 34, 132, 404, 325, 205, 82, 222, 138, 174, 311, 312, 121, 300, 90, 96, 231, 123, 298, 160, 335, 75, 91, 292, 369, 223, 18, 86, 87, 49, 385, 166, 72, 274, 47, 242, 324, 144, 355, 158, 234, 345, 22, 224, 197, 198, 206, 329, 118, 249, 58, 133, 263, 193, 280, 137, 303, 302, 103, 353, 196, 139, 173, 143, 29, 239, 15, 163, 172, 111, 252, 230, 42, 213, 220, 346, 347, 362, 185, 30, 31, 25, 106, 142, 36, 84, 16, 257, 241, 243, 262, 165, 147, 248, 288; Distribution: Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, B
Hazard: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

22 products in this recall

Philips X-ray systems recalled for faulty foot switch

Philips is recalling 22 models of its Allura Xper and Azurion X-ray imaging systems. The recall covers a wired foot switch that may fail to start X-ray imaging or may start it intermittently. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Allura Xper FD10C; System Code: 722001;
Z-1659-2026 · 15 units (7 US, 8 OUS)
ALLURA Xper FD10F; System Code: 722002;
Z-1660-2026 · 10 units (8 US, 2 OUS)
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
Z-1661-2026 · 2291 units (493 US, 1798 OUS)
ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;
Z-1662-2026 · 112 units (138 US, 422 OUS)
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
Z-1663-2026 · 5084 units (1616 US, 3468 OUS)
ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Z-1664-2026 · 461 units (198 US, 263 OUS)
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Z-1665-2026 · 196 units (73 US, 223 OUS)
ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;
Z-1666-2026 · 4 units (2 US, 2 OUS)
ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;
Z-1667-2026 · 2 units (1 US, 1 OUS)
Allura Xper FD20/10; System Code: 722029;
Z-1668-2026 · 85 units (20 US, 65 OUS)
Allura Xper FD20/20; System Code: 722038;
Z-1669-2026 · 111 units (31 US, 80 OUS)
Allura Xper FD20/20 OR Table; System Code: 722039;
Z-1670-2026 · 5 units (OUS only)
Allura Xper FD20/15; System Code: 722058;
Z-1671-2026 · 296 units (68 US, 228 OUS)
Allura Xper FD20/15 OR Table; System Code: 722059;
Z-1672-2026 · 2 units (2 US, 6 OUS)
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
Z-1673-2026 · 298 units (27 US, 271 OUS)
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);
Z-1674-2026 · 798 units (42 US, 756 OUS)
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
Z-1675-2026 · 670 units (106 US, 564 OUS)
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
Z-1676-2026 · 1523 units (322 US, 1201 OUS)
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
Z-1677-2026 · 1994 units (360 US, 1634 OUS)
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
Z-1678-2026 · 5167 units (1728 US, 3439 OUS)
Azurion 5 M12; System Code: (1)722227, (2)722231;
Z-1679-2026 · 345 units (10 US, 335 OUS)
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); (this page)
Z-1680-2026 · 920 units (168 US, 752 OUS)