PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (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: 920 units (168 US, 752 OUS) 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

UPC codes

00884838099234, 00884838116757, 00884838110564

Source

Official record: FDA (Device enforcement) ↗

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