Class 2 Device Recall Allura Xper FD; Allura Xper OR Table

• Date Initiated by Firm: January 02, 2024
• Date Posted: February 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1144-2024
• Recall Event ID: 93783
• 510(K)Number: K162859 K033737 K130842 K141979 K130638 K133292
• 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: FlexVision PC; ; Allura Xper Model Name - Model Number:; ; Allura Xper FD10; 722003; 722010; 722026;; ; Allura Xper FD10/10; 722005; 722011; 722027;; ; 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
• Code Information: Allura Xper FD10 722003 - no UDI Serial Numbers 1181 1187 1311 1349 1435 1594 1700 1788 268 285 368 390 445 467 472 485 913 940 , 722010 - UDI-DI 00884838059030 Serial Numbers 1005 1009 1011 1025 1028 1040 1041 1043 1048 1069 107 1078 1082 1084 1108 1109 1118 1123 1126 1128 1132 1149 1170 1173 1176 1181 1183 1209 1210 1230 1233 1234 1235 1236 1244 1261 1263 1275 1279 1283 1287 1292 1297 1298 1302 1309 1310 1328 133 1336 1344 1347 1365 1369 1370 1373 1395 1396 1397 1398 1424 1425 1432 1441 1442 175 190 215 244 252 280 33 343 344 365 40 414 42 43 468 488 500 527 585 646 667 668 679 68 690 714 728 754 755 763 767 780 785 787 788 791 818 821 826 830 838 839 873 882 896 902 905 917 920 921 931 932 939 965 968 970 976 986 987 992 999 , 722026 - UDI-DI 00884838054189 Serial Numbers 100 1000 101 102 1050 1051 1052 1068 1072 109 110 112 1126 1132 114 115 116 117 1182 1189 1192 1205 121 1215 122 1239 1248 1268 130 142 151 155 156 185 191 192 204 215 220 222 223 224 233 234 244 245 253 258 259 265 323 324 335 368 378 381 391 394 396 400 431 432 436 458 462 484 485 531 544 558 559 560 561 562 600 601 602 604 608 612 617 622 627 633 634 646 648 653 654 663 664 683 694 704 713 716 725 73 731 738 74 75 765 770 774 778 78 781 786 79 796 805 825 826 832 838 841 843 845 87 877 908 909 93 931 935 942 957 959 965 966 967 969 973 98 985 99 990 ; Allura Xper FD10/10 722005 - no UDI Serial Number 259 261 270 329 343 449 456 480 49 523 63 , 722011 - no UDI Serial Number 123 140 15 172 173 177 23 234 237 255 256 267 268 269 270 275 308 319 324 325 332 344 345 358 362 375 380 49 76 79 82 83 , 722027 - UDI-DI 00884838054196 Serial Number 1 104 106 107 112 116 120 123 127 134 153 156 164 174 175 179 183 202 203 216 222 230 231 234 240 241 255 263 265 266 280 284 288 29 298 305 306 307 32 332 335 342 351 39 41 42 43 49 50 56 71 ; Allura Xper FD20 722006 - UDI-DI 00884838059115 Serial Numbers 1000 1093 1114 1127 1132 1174 1221 1276 1318 1364 1383 1407 1420 1439 1444 1446 1476 1507 1588 1589 1627 1648 1661 1729 1761 1807 1830 1845 1848 1870 1875 1913 1921 1922 1942 1955 2122 2126 2143 2147 2183 2200 2203 2268 2274 2323 2404 39 518 559 560 587 641 680 683 700 722 767 774 810 886 904 , 722012 - UDI-DI 00884838059054, 00884838059191, or 00884838059207 Serial Numbers 100 101 1017 1020 1032 1034 1036 1038 1054 1058 1077 1083 1084 1097 1098 1099 1104 1113 1120 1140 1141 1166 1189 1192 1207 1210 1211 1212 1219 1224 1238 1239 1240 1249 1250 1254 1265 1269 1270 1277 1282 1285 1293 1294 1305 1306 1316 1317 1321 1324 1328 1329 1334 1335 1344 1345 1356 1357 1396 1399 1401 1404 1405 1406 1407 1408 141 1422 1426 1430 1440 1441 1447 1455 1461 1467 1478 1506 1507 1508 1513 1515 1516 1527 1532 1533 1537 1538 1542 1545 1549 1550 1558 1559 1560 1561 1570 1581 1588 1589 1593 1594 1595 1596 1597 1606 1607 1608 1610 1611 1616 1617 1622 1625 1635 1649 1656 1658 1659 1660 1661 1664 1672 1683 1688 1690 1692 1712 1713 1714 1715 1716 1723 1724 1726 1731 1732 1733 1734 1735 1743 1746 1792 1793 1796 1798 1803 1806 1807 1823 1832 1842 1848 1852 1854 1858 1868 1869 1871 1889 1904 1906 1908 1919 1922 1923 1924 1941 1943 1946 1953 1961 1964 197 1975 1989 1992 2002 2003 2013 2014 2015 2022 2046 2054 2057 2063 2065 2068 208 2085 2086 2092 2133 2135 2136 2138 2145 2146 2148 2149 2150 2151 2156 2166 2171 2202 2203 2207 2215 2219 2221 2222 2227 2234 224 2254 2264 2265 2269 2276 2286 2288 2289 2292 2293 2303 2305 2307 2308 2309 2311 2313 2319 2323 233 234 2353 239 2454 2469 2484 2506 2508 2511 2512 2514 2515 2516 2521 2522 2607 2609 2610 2614 2629 2645 2656 2657 2693 2696 2697 2707 2713 2722 2723 2726 2735 2736 2740 2741 2742 2755 2760 2774 2821 2828 2829 2835 2840 2841 2842 2843 2844 2849 2857 2868 2869 2873 2874 2875 2881 2883 2888 2889 2892 2896 2898 2899 2900 2901 2912 2920 2929 2930 2940 2943 314 323 336 379 380 383 394 412 424 430 435 440 442 446 447 450 452 470 484 511 518 520 527 560 570 580 589 596 605 633 644 649 650 655 666 675 676 685 686 69 694 695 718 760 787 788 790 791 792 828 84 856 859 893 92 920 923 925 926 943 95 950 952 953 954 963 974 975 986 99 , 722028 - UDI-DI 00884838054202, 00884838059191, 00884838059269 Serial Numbers 1 1000 1001 1004 1011 1014 1017 1022 1024 1030 1032 1034 1035 1041 1043 1050 1051 1054 1058 1068 1069 1074 1076 1077 1081 1094 1098 1099 11 110 1103 1111 1116 1122 1129 1130 1132 1136 1142 1149 1154 1155 1156 1168 1171 1188 1189 1191 1200 1201 121 1211 1212 1213 1214 122 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 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 1456 1457 1461 1463 1466 1472 1481 1482 1483 1484 1498 1499 1508 151 1514 1522 1538 1549 155 1556 1566 1567 1568 1569 1570 158 159 1598 1600 1619 1629 1633 1634 1639 1646 1649 1650 1656 1657 166 167 1677 169 1690 1705 1710 1716 172 1723 173 1736 1751 1755 1756 176 1774 1783 180 1811 1820 1822 1824 1826 1828 1834 1835 1836 1837 184 1845 1846 185 1850 1854 1855 1856 1869 1875 1880 1889 1890 190 1909 1920 1931 194 1945 1948 1949 195 1956 1957 197 1978 1980 1983 1984 1995 2007 2008 2020 203 204 205 2070 2071 2083 210 2103 211 2110 213 215 2151 216 217 2173 218 2192 2196 2200 2206 224 2252 2261 227 2275 228 2284 229 2293 2295 2310 2335 2348 236 237 238 242 254 257 260 261 262 265 267 272 273 274 275 2760 279 280 282 284 289 292 2922 2933 303 305 31 313 315 317 318 324 326 329 333 336 340 343 346 347 350 356 363 365 368 372 373 375 376 377 379 382 386 394 402 406 407 408 416 422 424 426 428 431 435 437 445 447 449 451 453 456 459 462 464 473 475 476 479 48 481 488 489 491 493 494 496 498 499 516 518 519 520 525 526 528 530 531 533 534 535 538 539 540 541 543 547 549 550 552 553 556 558 559 560 561 564 565 570 571 579 580 582 586 590 591 592 596 601 618 620 625 627 630 632 634 638 647 654 655 66 666 668 67 671 672 674 677 678 680 684 692 695 696 698 71 710 717 720 721 729 731 741 743 751 757 759 768 779 781 793 80 805 806 808 809 811 818 819 821 825 840 842 861 864 866 867 869 874 877 879 880 882 887 888 889 891 892 895 896 900 901 903 904 906 908 909 910 911 917 922 924 925 928 929 930 932 934 938 940 945 946 949 952 956 961 962 966 967 968 971 973 976 978 981 982 983 987 989 991 994 995 998 ; Allura Xper FD20 Biplane 722008 - no UDI Serial Numbers 115 124 142 1789 19 231 246 264 288 306 319 349 378 419 420 445 463 465 472 487 516 , 722013 - UDI-DI 00884838059061 or 00884838080805 Serial Numbers 100 115 124 129 140 148 150 151 152 175 203 205 214 217 218 253 264 268 274 278 297 30 303 307 313 327 328 330 342 347 357 360 375 377 379 383 401 402 410 422 424 426 427 428 435 441 442 45 461 462 467 475 479 480 481 491 492 495 496 497 500 505 511 513 518 519 550 556 562 564 573 575 580 599 601 603 626 631 634 637 69 74 84 ; 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 35 46 64 66 71 72 75 82 83 98 , 722035 - UDI-DI 00884838054240 Serial Numbers 100 101 117 119 121 123 124 125 126 127 131 143 145 161 165 169 172 183 187 192 196 21 212 216 222 236 24 242 243 244 245 246 247 252 30 34 38 46 52 57 59 60 72 74 85 88 89 ; Allura Xper FD20/10 722029 - UDI-DI 00884838054219 Serial Numbers 110 126 129 21 22 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 100 109 111 123 124 129 134 135 138 146 149 156 167 168 171 172 178 186 190 196 197 199 200 202 203 205 212 215 219 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 38 405 5 56 59 61 65 71 82 85 94 ; Allura Xper FD20/15 OR Table 722059 - UDI-DI 00884838059122 Serial Numbers 33 7 ; Allura Xper FD20/20 722038 - UDI-DI 00884838054226 Serial Numbers 106 108 115 118 119 120 126 130 137 141 157 167 173 35 37 38 39 41 42 46 49 55 60 63 67 7 70 71 ; 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: Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result 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 Framegrabber Card 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: 1,993 US; 2,662 OUS
• Distribution: Worldwide - US Nationwide distribution.
• 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.