Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

Recall details

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Distributor

Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, and Yemen.

Lot

Allura Xper FD10 722003 - no UDI Serial Numbers 1031 105 1074 1114 1181 1187 1209 1311 1349 1435 1472 1529 1555 1594 1700 1719 1788 268 283 285 368 390 445 467 472 482 485 690 906 912 913 928 940 , 722010 - UDI-DI 00884838059030 or 00884838059191, some units do not have UDI Serial Numbers 1005 1009 1011 1025 1028 1040 1041 1042 1043 1048 1064 1069 107 1078 1082 1084 1108 1109 1112 1118 1123 1126 1128 1132 1144 1149 1170 1173 1176 1181 1183 1209 1210 1214 1226 1230 1233 1234 1235 1236 1244 1261 1263 1275 1279 1283 1287 1292 1297 1298 1302 1308 1309 1310 1312 1328 133 1336 1344 1347 1365 1369 1370 1373 1391 1395 1396 1397 1398 1424 1425 1428 1432 1436 1440 1441 1442 145 158 170 175 177 190 191 209 214 215 218 227 241 244 252 280 281 285 286 290 314 327 33 337 343 344 359 360 365 38 39 40 414 42 422 423 43 453 467 468 477 478 479 480 485 488 500 505 521 527 531 567 572 585 592 604 605 609 61 611 624 636 637 638 641 646 648 65 651 656 662 667 668 670 671 673 675 677 679 68 683 690 693 694 698 714 728 730 754 755 763 764 767 780 784 785 787 788 791 792 794 809 818 821 826 830 833 838 839 873 878 882 890 896 902 905 914 917 920 921 931 932 937 939 946 965 968 970 976 979 986 987 992 999 , 722026 - UDI-DI 00884838054189 Serial Numbers 100 1000 101 102 1038 1050 1051 1052 1068 1072 109 11 110 1100 1101 112 1126 1129 1132 114 115 116 117 1182 1189 1192 1205 121 1210 1215 122 1231 1239 1246 1248 1268 1287 1293 130 1338 1340 142 151 155 156 185 190 191 192 201 204 205 215 220 221 222 223 224 233 234 235 244 245 253 258 259 265 284 287 297 319 323 324 335 344 368 370 374 378 381 389 391 394 396 400 431 432 436 444 458 462 465 484 485 512 522 531 543 544 558 559 560 561 562 563 600 601 602 604 605 608 612 614 617 618 622 627 633 634 646 648 653 654 663 664 683 688 694 696 704 713 716 725 728 73 731 738 74 75 765 770 774 778 78 781 782 786 79 796 805 825 826 832 838 841 843 845 855 87 877 878 882 908 909 914 93 931 935 942 957 959 965 966 967 969 973 98 985 99 990 ; Allura Xper FD10 OR Table 722022 - No UDI Serial Number 6 ; Allura Xper FD10/10 722005 - UDI-DI 00884838080805 Serial Numbers 212 259 261 270 329 343 344 392 399 449 456 474 480 49 523 63 , 722011 - no UDI Serial Numbers 101 102 103 107 123 124 132 133 137 140 15 155 157 163 168 169 170 171 172 173 177 196 205 23 234 237 255 256 267 268 269 270 275 279 308 319 324 325 33 332 344 345 358 362 375 380 44 49 57 58 59 72 76 79 82 83 84 87 95 , 722027 - UDI-DI 00884838054196 or 00884838059191 Serial Numbers 1 104 106 107 112 116 120 123 127 133 134 152 153 156 164 169 174 175 178 179 183 202 203 209 216 222 230 231 234 240 241 246 255 263 265 266 267 280 284 288 29 298 305 306 307 319 32 332 335 342 351 39 40 41 42 43 49 50 56 71 ; Allura Xper FD10C 722001 - no UDI Serial Numbers 213 273 ; Allura Xper FD20 722006 - UDI-DI 00884838059115 Serial Numbers 1000 1007 1093 1104 1114 1127 1132 1174 120 1210 1221 1235 1259 1276 1318 1341 1364 1383 1387 1407 1420 1439 1444 1446 1461 1469 1476 1480 1507 1588 1589 1604 1610 1627 1648 1659 1661 1705 1720 1729 1752 1761 1772 1792 1807 1812 1827 1830 1845 1846 1848 1870 1872 1875 1888 1913 1921 1922 1942 1955 2002 2007 2008 2042 2058 2122 2126 2135 2140 2143 2147 2183 2195 2199 2200 2203 2268 2274 2283 2323 2404 2425 39 45 468 518 559 560 587 638 641 673 674 675 680 683 700 722 723 767 774 776 804 806 810 878 882 886 904 972 , 722012 - UDI-DI 00884838059054, 00884838059191, or 00884838059207 Serial Numbers 100 1001 1002 1003 1004 1005 101 1014 1016 1017 1019 1020 1022 1023 1026 1027 103 1032 1033 1034 1035 1036 1037 1038 104 1044 1045 1047 1053 1054 1058 1062 1063 1073 1075 1077 1078 1083 1084 1091 1092 1095 1096 1097 1098 1099 1100 1101 1102 1104 1105 1106 1108 1113 1115 1116 1117 1118 1119 1120 1126 1133 114 1140 1141 1148 1154 1166 1167 1177 1181 1187 1188 1189 1192 1195 1197 1207 1209 1210 1211 1212 1216 1217 1218 1219 1224 1226 123 1231 1238 1239 124 1240 1249 1250 1254 1255 126 1262 1265 1269 1270 1271 1272 1277 1279 1280 1281 1282 1285 12

Risk classification

Class II

Area (FDA)

device

Country

Netherlands