Recall Weekly
Moderate riskFDA DeviceClass II

Philips Azurion 3 M15 X-ray system recalled for foot switch malfunction

Philips has identified a problem with the wired foot switch on certain Azurion 3 M15 X-ray imaging systems where X-ray imaging may not start or may work intermittently. This affects specific serial numbers of the system manufactured by Philips Medical Systems Nederland B.V. and distributed worldwide.

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

What to do

  1. If you operate an Azurion 3 M15 system, check your serial number against the affected list
  2. Contact Philips immediately if your system's serial number is listed
  3. Do not use the wired foot switch if you suspect a malfunction—follow Philips's guidance for safe operation
  4. Await instructions from Philips regarding repair or replacement
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (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
798 units (42 US, 756 OUS)
Illnesses reported
None reported
Manufactured in
Veenpluis 6, Best, Netherlands
Classification
Class II
Recall number
Z-1674-2026

In the FDA's words

Description
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (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: 722064; UDI: 00884838085282; System Serial Number: 209, 238, 201, 258, 260, 261, 314, 229, 291, 270, 267, 218, 335, 513, 61, 161, 162, 169, 297, 131, 479, 190, 268, 173, 220, 256, 290, 502, 425, 412, 89, 303, 130, 157, 60, 263, 264, 253, 254, 257, 280, 373, 417, 9, 277, 102, 467, 461, 137, 46, 101, 84, 510, 5, 78, 49, 345, 180, 185, 266, 271, 193, 212, 213, 214, 431, 250, 186, 246, 282, 354, 374, 274, 127, 451, 106, 490, 329, 276, 58, 81, 200, 179, 249, 156, 184, 6, 448, 10, 82, 323, 35, 69, 278, 511, 39, 40, 45, 66, 125, 484, 36, 94, 497, 104, 422, 132, 67, 183, 439, 70, 446, 50, 138, 292, 293, 321, 379, 151, 237, 519, 520, 208, 462, 342, 57, 222, 391, 98, 441, 320, 494, 79, 65, 87, 109, 75, 311, 442, 485, 121, 68, 384, 228, 252, 91, 73, 74, 124, 191, 122, 421, 119, 309, 400, 251, 468, 480, 387, 269, 111, 11, 147, 509, 454, 478, 262, 491, 133, 337, 275, 414, 405, 396, 247, 310, 406, 517, 432, 457, 426, 304, 469, 340, 393, 343, 458, 322, 444, 508, 445, 395, 385, 505, 472, 514, 333, 236, 471, 234, 503, 394, 407, 470, 498, 504, 413, 7, 440, 463, 330, 475, 473, 501, 308, 225, 483, 474, 344, 389, 492, 324, 265, 235, 120, 496, 427, 341, 287, 288, 289, 380, 149, 150, 176, 197, 230, 231, 233, 44, 100, 51, 388, 118, 62, 123, 177, 47, 272, 110, 59, 167, 174, 165, 401, 452, 41, 168, 447, 148, 182, 112, 302, 86, 317, 198, 378, 206, 136, 312, 143, 403, 386, 397, 500, 226, 408, 43, 381, 488, 443, 416, 80, 12, 404, 285, 515, 476, 449, 477, 338, 419, 215, 164, 434, 114, 144, 327, 227, 295, 294, 319, 241, 126, 92, 284, 175, 199, 372, 188, 429, 296, 172, 283, 357, 306, 437, 210, 315, 134, 255, 207, 192, 116, 221, 189, 117, 313, 187, 166, 96, 135, 108, 37, 245, 72; (2) System Code: 722222; UDI: 00884838099210; System Serial Number: 332, 111, 254, 256, 257, 265, 255, 100, 99, 310, 69, 12, 226, 15, 19, 23, 17, 55, 45, 187, 223, 358, 112, 113, 367, 120, 356, 262, 37, 318, 152, 364, 146, 246, 269, 75, 304, 316, 174, 230, 307, 320, 336, 338, 339, 340, 343, 344, 345, 346, 362, 308, 182, 27, 56, 312, 368, 172, 137, 302, 328, 35, 383, 96, 382, 151, 138, 384, 363, 224, 386, 395, 102, 118, 119, 145, 209, 210, 331, 351, 372, 373, 361, 88, 89, 108, 132, 48, 53, 4, 305, 80, 83, 47, 270, 21, 64, 22, 98, 29, 248, 266, 378, 245, 18, 24, 335, 177, 11, 72, 244, 9, 66, 50, 263, 65, 278, 82, 188, 68, 51, 5, 76, 243, 139, 319, 31, 193, 106, 392, 287, 178, 117, 267, 92, 324, 213, 281, 229, 215, 300, 268, 104, 353, 141, 133, 142, 105, 250, 251, 252, 253, 183, 375, 311, 228, 322, 189, 297, 190, 313, 169, 219, 247, 282, 217, 143, 349, 225, 162, 333, 185, 166, 161, 369, 134, 222, 389, 370, 374, 396, 399, 280, 249, 115, 321, 211, 168, 127, 261, 54, 14, 38, 10, 67, 165, 272, 326, 173, 90, 109, 13, 288, 289, 290, 291, 294, 295, 292, 186, 181, 107, 379, 385, 296, 314, 315, 390, 77, 354, 380, 110, 184, 180, 131, 284, 376, 366, 214, 116, 276, 73, 365, 398, 157, 87, 114, 274, 135, 159, 158, 78, 125, 218, 124, 126, 192, 212, 149; (3) System Code: 722230; UDI: 00884838116733; System Serial Number: 40, 2, 22, 10, 50, 4, 5, 19, 20, 23, 25, 30, 41, 67, 7, 45, 15, 28, 60, 38, 9, 62, 63, 57, 58, 54, 55, 39, 27, 52, 13, 12, 1, 68; (4) System Code: 722280; UDI: 00884838103276; System Serial Number: 57, 161, 43, 179, 229, 249, 65, 76, 232, 113, 167, 165, 80, 128, 158, 149, 194, 44, 100, 164, 240, 246, 66, 135, 175, 99, 112, 34, 79, 130, 48, 52, 141, 131, 142, 143, 144, 189, 37, 83, 223, 139, 87, 61, 259, 218, 90, 188, 105, 23, 30, 132, 96, 107, 171, 118, 21, 174, 220, 147, 133, 264, 38, 243, 177, 178, 150, 69, 148, 210, 207, 98, 211, 127, 222, 198, 71, 146, 241, 206, 152, 262, 157, 40, 17, 204, 260, 187, 208, 46, 235, 234, 91, 97, 153, 245, 106, 173, 258, 120, 45, 92, 226, 254, 213, 224, 95, 54, 126, 216, 19, 271, 215, 93, 24, 129, 74, 219, 88, 85, 86, 170, 55, 102, 123, 124, 125, 151, 39, 47, 101, 209, 41, 42, 53, 250, 239, 248, 108, 119, 205, 197, 82, 33, 20, 231, 63, 261, 138, 255, 212, 84, 221, 36, 247, 256, 59, 196, 50, 110, 199, 140, 68, 117, 49, 257, 60, 103, 237, 72, 160, 81, 114, 137, 58, 73, 35, 22, 94; 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
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.

More from Philips

See all

Related topics

OtherSoftwareMedical devicesSold nationwideMore from FDA Device