Class II Recall

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

Summary

The FDA issued a Class II for Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch..

Details

Source

Device Recall

External ID

Z-1680-2026

Action Date

2026-04-08

Status

Ongoing

Product Description

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

Lot/Code Info: (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;

Quantity Affected: 920 units (168 US, 752 OUS)

Reason for Recall

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Distribution

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;

Type: Voluntary: Firm initiated

Recall Initiated: 2026-03-03

Company

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Best

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 252 device recalls issued in the same week, part of 413 device-related FDA actions this month.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1680-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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