PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

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: 1523 units (322 US, 1201 OUS) Lot/code info: (1) System Code: 722068; UDI: 00884838085367; System Serial Number: 547, 178, 467, 335, 147, 205, 170, 455, 494, 564, 418, 95, 440, 247, 225, 64, 149, 42, 153, 324, 323, 320, 85, 89, 109, 407, 239, 505, 271, 443, 104, 370, 322, 136, 373, 442, 524, 308, 354, 75, 279, 400, 196, 510, 110, 446, 78, 330, 73, 288, 285, 295, 406, 528, 329, 184, 350, 462, 304, 457, 470, 472, 319, 520, 490, 243, 103, 479, 261, 262, 150, 277, 172, 117, 130, 356, 143, 146, 84, 251, 469, 431, 361, 76, 374, 270, 114, 511, 477, 232, 137, 282, 487, 413, 337, 101, 213, 82, 265, 275, 485, 459, 276, 62, 506, 608, 473, 417, 302, 314, 88, 126, 211, 468, 422, 454, 410, 283, 231, 548, 466, 495, 207, 167, 445, 537, 438, 173, 233, 289, 536, 192, 204, 77, 166, 313, 236, 133, 481, 280, 307, 577, 210, 258, 328, 325, 199, 480, 53, 72, 364, 491, 423, 509, 246, 614, 142, 376, 539, 257, 140, 369, 195, 500, 508, 97, 87, 303, 48, 44, 301, 550, 460, 118, 293, 551, 478, 522, 568, 448, 242, 238, 68, 160, 83, 544, 230, 434, 435, 360, 93, 36, 372, 179, 306, 182, 583, 327, 244, 382, 428, 432, 215, 447, 338, 399, 339, 316, 555, 552, 570, 347, 148, 134, 38, 560, 158, 535, 318, 518, 250, 336, 185, 206, 50, 489, 521, 37, 79, 529, 111, 254, 427, 394, 71, 47, 534, 292, 497, 591, 35, 227, 359, 527, 387, 168, 128, 129, 396, 515, 486, 543, 69, 453, 174, 483, 484, 334, 425, 181, 408, 415, 141, 365, 471, 540, 584, 553, 602, 240, 617, 604, 593, 589, 526, 559, 612, 450, 556, 557, 574, 603, 601, 609, 616, 597, 605, 575, 516, 624, 599, 563, 590,

UPC codes

00884838085367, 00884838099272, 00884838116788

Source

Official record: FDA (Device enforcement) ↗

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