Class 2 Device Recall Allura Xper FD series and Allura Xper OR Table series

• Date Initiated by Firm: January 02, 2024
• Date Posted: February 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1151-2024
• Recall Event ID: 93781
• 510(K)Number: K162859 K031333 K130638 K141979 K161563 K163715
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: 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.)
• Code Information: 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 1286 1293 1294 1301 1305 1306 1307 1316 1317 1321 1324 1326 1327 1328 1329 1334 1335 1336 1337 1344 1345 1354 1356 1357 1359 1396 1399 1401 1404 1405 1406 1407 1408 141 1422 1426 1430 1440 1441 1442 1446 1447 1455 1456 1461 1467 1473 1477 1478 1497 150 1506 1507 1508 1512 1513 1515 1516 1519 1527 1531 1532 1533 1537 1538 1542 1545 1549 1550 1558 1559 1560 1561 1570 1581 1583 1586 1587 1588 1589 1590 1593 1594 1595 1596 1597 1598 1599 1606 1607 1608 1610 1611 1613 1616 1617 1622 1625 1630 1635 1636 1641 1645 1649 1652 1656 1657 1658 1659 1660 1661 1662 1664 1665 1672 1673 1675 1683 1686 1688 1690 1692 1712 1713 1714 1715 1716 172 1723 1724 1726 1731 1732 1733 1734 1735 174 1743 1746 1792 1793 1796 1797 1798 1799 1803 1804 1805 1806 1807 1809 1811 1823 1827 1832 1842 1848 1852 1854 1858 186 1868 1869 1871 1889 1894 1895 1900 1904 1906 1908 1916 1918 1919 1922 1923 1924 1941 1943 1945 1946 1947 1948 195 1950 1953 196 1960 1961 1964 197 1975 1989 1990 1992 1993 2002 2003 2004 2006 2013 2014 2015 2022 2046 2054 2057 2063 2064 2065 2068 208 2081 2085 2086 209 2092 2133 2134 2135 2136 2138 2145 2146 2148 2149 2150 2151 2156 2161 2166 2171 2201 2202 2203 2207 2215 2219 2221 2222 2227 2234 224 2254 2264 2265 2269 2276 2283 2285 2286 2288 2289 2292 2293 2302 2303 2305 2307 2308 2309 231 2310 2311 2313 2319 2323 233 234 2353 239 243 2454 2469 248 2484 2496 2506 2508 2509 2511 2512 2514 2515 2516 2518 2521 2522 2607 2609 2610 2614 2629 2645 2653 2655 2656 2657 2658 2677 2687 2692 2693 2696 2697 2707 2712 2713 2721 2722 2723 2726 2735 2736 274 2740 2741 2742 2753 2755 2760 277 2774 2821 2828 2829 2835 2840 2841 2842 2843 2844 2849 2855 2856 2857 2868 2869 2873 2874 2875 2876 2881 2883 2886 2888 2889 2890 2892 2896 2898 2899 2900 2901 2912 2920 2924 2925 2926 2929 2930 2933 2937 2938 2940 2943 299 310 314 315 316 320 322 323 326 334 336 337 348 351 352 369 371 379 380 383 386 389 394 404 406 412 424 430 435 440 442 444 445 446 447 448 450 452 453 456 470 473 474 476 483 484 489 494 498 499 505 511 51251061 513 518 520 527 531 533 542 560 562 565 568 570 574 577 578 579 580 583 585 589 590 596 597 601 605 606 613 615 633 639 642 643 644 649 650 651 655 656 66 666 669 67 671 675 676 68 685 686 689 69 690 691 694 695 70 718 731 732 733 735 740 741 751 756 757 758 76 760 766 767 768 782 787 788 789 790 791 792 796 797 814 815 823 828 84 846 848 851 852 855 856 858 859 86 861 865 878 88 888 892 893 894 909 919 92 920 923 924 925 926 93 934 935 939 943 948 95 950 951 952 953 954 959 963 964 971 973 974 975 976 986 989 99 990 D902-214-00 , 722028 - UDI-DI 00884838054202, 00884838059191, 00884838059269 Serial Numbers 1 1000 1001 1002 1004 1011 1014 1017 1022 1024 1030 1032 1034 1035 1041 1043 1049 1050 1051 1054 1058 1068 1069 1074 1076 1077 1081 1085 1094 1095 1098 1099 11 110 1100 1103 1111 1116 1122 1129 1130 1132 1136 1142 1149 1154 1155 1156 1168 1171 1187 1188 1189 1191 1200 1201 1202 121 1211 1212 1213 1214 122 1222 1232 1233 1244 125 1256 1261 1264 1266 1267 1269 127 1275 1279 128 1286 1288 129 130 131 1310 1311 132 1326 1327 133 1331 1333 1340 1343 1349 1350 1351 1352 1353 1359 136 1368 137 1370 1373 1374 138 1385 1387 139 1393 1394 1395 1396 1397 140 1405 1407 1408 141 1413 142 1424 1428 143 1439 1441 1446 1447 1448 145 1454 1456 1457 1461 1463 1466 1472 1481 1482 1483 1484 1498 1499 1508 151 1514 1522 1538 154 1549 155 1556 1566 1567 1568 1569 1570 158 159 1598 160 1600 161 1619 1629 1630 1633 1634 1639 1646 1649 1650 1651 1652 1656 1657 166 167 1677 169 1690 1705 1708 1710 1716 172 1723 173 1736 1751 1755 1756 176 1774 1783 180 1809 1811 1820 1822 1824 1826 1828 1834 1835 1836 1837 184 1845 1846 185 1850 1854 1855 1856 1869 1870 1875 1880 1889 189 1890 190 1909 1920 1930 1931 194 1945 1946 1948 1949 195 1956 1957 197 1978 1980 1983 1984 1988 1995 2007 2008 2020 203 204 205 206 2061 207 2070 2071 208 2083 209 210 2103 211 2110 213 215 2151 216 217 2173 2174 218 2192 2196 2200 2206 222 224 2249 2252 2253 2261 227 2275 228 2284 229 2293 2295 2310 2335 234 2348 236 237 238 2407 242 2422 2502 2506 251 254 256 257 260 2601 261 2615 262 2635 2641 2645 2647 265 267 2707 2709 2710 272 273 274 2745 275 2760 279 280 281 282 283 2834 284 2843 2846 289 2906 292 2922 2933 303 305 306 31 310 313 315 316 317 318 324 326 329 333 336 339 340 343 346 347 350 356 361 363 364 365 368 371 372 373 375 376 377 379 382 386 394 402 406 407 408 416 419 420 422 424 426 428 431 435 437 445 447 449 451 452 453 454 456 459 462 463 464 466 468 473 475 476 479 48 481 485 488 489 490 491 493 494 496 498 499 516 518 519 52 520 521 522 525 526 528 529 530 531 533 534 535 538 539 540 541 543 547 548 549 550 552 553 556 558 559 560 561 564 565 570 571 579 580 582 586 590 591 592 596 601 618 620 625 627 630 631 632 634 636 637 638 647 654 655 66 664 666 668 669 67 671 672 674 675 677 678 680 684 691 692 695 696 697 698 71 710 717 720 721 729 731 734 741 743 744 751 757 759 768 774 779 781 784 785 793 80 805 806 808 809 811 818 819 821 825 840 842 854 861 864 866 867 869 874 877 879 880 882 887 888 889 891 892 893 895 896 900 901 903 904 906 908 909 910 911 914 917 918 922 924 925 928 929 930 932 934 938 940 945 946 949 952 956 961 962 966 967 968 971 973 976 977 978 981 982 983 987 989 990 991 994 995 998 ; Allura Xper FD20 Biplane 722008 - no UDI Serial Numbers 115 124 133 142 173 1789 19 197 231 246 264 267 288 306 312 319 349 378 419 420 445 453 463 465 472 487 491 516 521 , 722013 - UDI-DI 00884838059061 or 00884838080805 Serial Numbers 100 105 106 113 115 124 125 126 129 140 141 147 148 149 150 151 152 153 159 160 164 170 174 175 178 179 194 203 205 213 214 216 217 218 228 241 244 246 249 253 254 255 262 264 266 267 268 269 274 278 289 290 293 297 30 303 304 307 308 309 313 316 327 328 330 342 346 347 35 351 357 360 375 377 379 383 389 392 401 402 404 410 42 422 424 426 427 428 43 435 441 442 45 46 461 462 467 475 479 480 481 491 492 495 496 497 500 505 507 511 513 515 518 519 531 550 556 561 562 564 573 575 580 599 601 603 61 626 631 634 637 638 639 69 72 74 77 84 85 96 ; Allura Xper FD20 Biplane OR Table 722025 - no UDI Serial Numbers 2 3 ; Allura Xper FD20 OR Table 722023 - UDI-DI 00884838059085 Serial Numbers 109 110 113 116 117 118 12 124 127 128 138 142 147 160 175 179 18 26 27 35 41 42 46 49 64 66 71 72 75 82 83 98 , 722035 - UDI-DI 00884838054240 Serial Numbers 100 101 117 119 121 123 124 125 126 127 131 143 145 147 161 165 169 172 183 187 192 196 21 212 216 222 236 24 242 243 244 245 246 247 252 30 34 38 46 47 52 57 59 60 72 74 85 88 89 ; Allura Xper FD20/10 722029 - UDI-DI 00884838054219 Serial Numbers 100 110 126 129 21 22 30 31 36 55 56 57 60 62 63 7 71 84 88 91 94 95 97 ; Allura Xper FD20/15 722058 - UDI-DI 00884838059115 or 00884838059191 Serial Numbers 100 109 111 123 124 129 134 135 138 146 149 156 162 167 168 171 172 178 182 186 190 196 197 199 200 202 203 205 212 215 219 22 23 238 239 24 249 254 257 259 264 265 274 277 278 279 285 288 290 304 305 319 325 337 340 365 366 373 378 38 4 405 5 56 59 61 65 71 82 85 94 99 ; Allura Xper FD20/15 OR Table 722059 - UDI-DI 00884838059122 Serial Numbers 33 7 ; Allura Xper FD20/20 722038 - UDI-DI 00884838054226 Serial Numbers 106 108 115 118 119 120 126 130 131 137 141 157 167 173 35 37 38 39 41 42 46 48 49 55 60 62 63 67 7 70 71 78 96 99 ; Allura Xper FD20/20 OR Table 722039 - No UDI Serial Number 3
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
• FDA Determined Cause: Process design
• Action: On January 2, 2024, the firm notified affected consignees via" URGENT Medical Device Correction" letters. These letters covered issues with three components of the PCs that may not perform as intended and which may therefore lead to delay in treatment: 1) DIMMs, 2) Disk Bay, and 3) Framegrabber Card. This recall record is for the Disk Bay issue. Customers should circulate the notice to all users and establish an emergency protocol for if you experience the issue during a procedure. Customers were provided with monitoring activities to undertake while waiting for their system to be corrected. Philips will be replacing the three components in all affected systems. Philips will contact customers to schedule a visit to replace the affected components. If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
• Quantity in Commerce: 13, 133 (3,408 US; 9,725 ROW)
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV; 510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHERLAND, B.V.; 510(K)s with Product Code = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.