Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-1674-2026

Z-1674-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

FDA device recall Z-1674-2026 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on March 3, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 798 units (42 US, 756 OUS).

Recall Details

Product Type
Devices
Report Date
April 8, 2026
Initiation Date
March 3, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
798 units (42 US, 756 OUS)

Product Description

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

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 Pattern

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;

Code Information

(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;

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-2412-2026 Class II — Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura (May 18, 2026)
  • Z-2411-2026 Class II — Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 (May 18, 2026)
  • Z-2258-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, (April 30, 2026)
  • Z-2259-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003 (April 30, 2026)
  • Z-2227-2026 Class II — Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), (April 28, 2026)
  • Z-2229-2026 Class II — Integris-Allura system; System Code Description (Model Numbers): Integris CV Ces (April 28, 2026)
  • Z-2225-2026 Class II — Philips Azurion systems not configured with an optional auxiliary pan handle. In (April 28, 2026)
  • Z-2228-2026 Class II — Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72200 (April 28, 2026)
  • Z-2170-2026 Class II — Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, (March 31, 2026)
  • Z-1805-2026 Class II — Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic (March 19, 2026)

FDA data resources