Allura Xper

Serial numbers affected:  17, 21, 22, 39, 44, 48, 49, 52, 54, 60, 81, 83, 93, 107, 111, 118, 121, 122, 135, 141, 144, 145, 153, 159, 160, 163, 165, 166, 167, 168, 170, 175, 176, 178, 179, 183, 184, 186, 187, 190, 191, 195, 196, 202, 203, 207, 211, 212, 213, 214, 220, 222, 225, 230, 231, 232, 234, 239, 246, 248, 249, 250, 251, 252, 254, 255, 262, 263, 265, 269, 270, 272, 277, 278, 283, 285, 286, 287, 289, 294, 301, 302, 303, 304, 306, 308, 310, 314, 315, 318, 321, 326, 327, 332, 337, 340, 341, 343, 347, 361, 362, 366, 369, 376, 379, 384, 387, 388, 389, 396, 404, 423, 425, 426, 435, 439, 445, 458, 467, 468, 469, 470, 471, 472, 479, 490, 494, 498, 504, 512, 514, 515, 518, 520, 521, 523, 528, 532, 534, 535, 543, 545, 553, 554, 559, 560, 579, 582, 586, 587, 588, 591, 592, 593, 595, 596, 599, 601, 602, 604, 606, 609, 611, 612, 615, 616, 618, 622, 623, 625, 626, 627, 628, 632, 634, 637, 638, 641, 642, 647, 649, 651, 654, 655, 658, 661, 663, 664, 667, 668, 670, 671, 672, 673, 674, 675, 676, 677, 678, 679, 680, 681, 683, 685, 686, 689, 691, 692, 694, 700, 701, 702, 705, 706, 707, 709, 716, 718, 722, 723, 730, 731, 737, 738, 741, 742, 744, 746, 750, 751, 752, 753, 754, 759, 765, 766, 770, 771, 773, 774, 775, 776, 777, 778, 779, 780, 781, 782, 785, 786, 788, 789, 790, 796, 797, 800, 804, 806, 808, 810, 813, 816, 821, 822, 823, 825, 826, 827, 828, 829, 830, 840, 841, 842, 843, 844, 845, 847, 848, 849, 850, 851, 852, 853, 857, 860, 861, 862, 863, 878, 882, 882, 886, 888, 892, 893, 894, 895, 896, 903, 904, 905, 906, 907, 908, 910, 911, 912, 913, 914, 919, 920, 921, 923, 924, 927, 929, 930, 933, 934, 939, 942, 943, 953, 959, 960, 961, 962, 966, 968, 970, 971, 972, 976, 984, 991, 992, 993, 994, 1007, 1009, 1015, 1032, 1038, 1044, 1045, 1046, 1056, 1075, 1076, 1081, 1085, 1090, 1092, 1093, 1095, 1096, 1098, 1103, 1104, 1105, 1107, 1108, 1114, 1115, 1116, 1118, 1119, 1124, 1126, 1127, 1128, 1132, 1138, 1139, 1140, 1141, 1145, 1147, 1150, 1153, 1161, 1166, 1167, 1168, 1169, 1170, 1174, 1176, 1177, 1178, 1179, 1183, 1187, 1188, 1189, 1190, 1195, 1196, 1201, 1202, 1205, 1206, 1207, 1209, 1211, 1221, 1223, 1227, 1228, 1229, 1235, 1236, 1237, 1240, 1241, 1242, 1252, 1253, 1256, 1258, 1259, 1267, 1268, 1269, 1273, 1274, 1276, 1277, 1279, 1291, 1293, 1294, 1297, 1298, 1300, 1302, 1318, 1321, 1326, 1331, 1338, 1364, 1374, 18165, 43041, 43048, 43051, 43057, 43068, 43070, 43076, 43080, 43081, 43090, 43093, 1674122, 521, 9A, and CG22N41.

Radiology Devices

2

No

Nationwide

Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021

Serial numbers affected:  18, 19, 22, 23, 24, 32, 33, 34, 36, 38, 52, 54, 56, 67, 68, 69, 71, 73, 74, 82, 84, 94, 99, 100, 102, 103, 106, 108, 112, 113, 116, 124, 125, 126, 131, 133, 141, 142, 148, 154, 157, 173, 174, 176, 178, 187, 191, 192, 197, 199, 212, and 691.

Radiology Devices

2

No

Nationwide

Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021

Software releases: PBL 6.5.1 1PBL 6.5.2 1PBL 7.0.x 1PBL 7.2.x

Radiology Devices

2

No

Nationwide Distribution

Allura Xper Systems Models: || Allura Xper FD10 (F/C)-Biplane Fixed || Allura Xper FD10/10 (incl. OR table) || Allura Xper FD20- High resolution fixed-x ray || Allura Xper FD20/10 || Allura Xper FD20/20 || Allura CV20 || The Allura Xper F010, FD10/10, FD20, FD20/10 and FD20/20 Use From Labeling): is intended for use in cardiovascular and vascular X-ray imaging applications. including diagnostic,interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral. thoracic and abdominal angiography, as well as PTCAs. stent placements, embolisations and thrombolysis. and Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and Electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Use of the Allura Xper FD Series in the OR environment is restricted; the system should only be used for minimally invasive procedures. (Endovascular)

Allura Xper Software version: R8.2.0

Radiology Devices

2

No

Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.

Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. || The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.

Allura Xper Software version R8.2.0

Radiology Devices

2

No

Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.

Philips Medical Systems Allura Xper FD20C with software version R8.2.O || System Code: 722035. || The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.