PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Al

Hazard

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.

Details from the source

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. Distribution: Worldwide - US Nationwide distribution. Quantity: 1,993 US; 2,662 OUS Lot/code info: 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

UPC codes

00884838059030, 00884838054189, 00884838054196, 00884838059115, 00884838059054, 00884838059191, 00884838059207, 00884838054202, 00884838059269, 00884838059061, 00884838080805, 00884838059085, 00884838054240, 00884838054219, 00884838059122, 00884838054226

Source

Official record: FDA (Device enforcement) ↗

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