PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

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: 112 units (138 US, 422 OUS) Lot/code info: (1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169, 305, 565, 419, 269, 258, 346, 474, 497, 530, 261, 523, 384, 388, 271, 233, 367, 270, 427, 343, 399, 360, 212, 251, 112, 520, 70, 392, 128, 357, 485, 405, 306, 307, 467, 234, 287, 333, 533, 209, 369, 543, 332, 328, 366, 389, 538, 394, 378, 379, 237, 165, 238, 2724, 415, 482, 397, 53, 385, 52, 531, 58, 499, 229, 374, 25, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 511, 428, 500, 463, 464, 14, 459, 416, 359, 487, 74, 457, 564, 469, 72, 125, 494, 519, 373, 76; (2) System Code: 722011; UDI: 00884838059047; System Serial Number: 49, 137, 375, 332, 102, 103, 95, 107, 380, 132, 171, 157, 270, 362, 76, 79, 22, 234, 308, 34, 324, 177, 84, 82, 319, 17, 133, 168, 345, 344, 83, 59, 15, 170, 163, 101, 255, 173, 325, 87, 155, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 186, 300, 213, 372, 41, 55, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199, 194, 108, 74, 75, 301, 302, 303, 304, 305, 306, 307, 18, 293, 294, 184, 266, 146, 116, 68, 310, 88, 272, 238, 152, 286, 309, 43, 334, 338, 165, 80, 112, 233, 188, 139, 141, 99, 277, 313, 223, 27, 29, 26, 340, 69, 367, 374, 328, 228, 251, 231, 323, 224, 81, 145, 66, 117, 153, 6, 129, 355, 91, 227, 202, 114, 274, 21, 377, 376, 378, 257, 265, 127, 180, 259, 211, 206, 217, 314, 98, 201, 341, 347, 261, 178, 183, 271, 230, 317, 198, 321, 204, 94, 244, 287, 38, 176, 39, 282, 329, 246, 295, 337, 292, 125

UPC codes

00884838059047, 00884838054196

Source

Official record: FDA (Device enforcement) ↗

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