PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

Hazard

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

Details from the source

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, Quantity: 798 units (42 US, 756 OUS) Lot/code info: (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

UPC codes

00884838085282, 00884838099210, 00884838116733, 00884838103276

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.