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: Imaging Processi

Hazard

Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.

Details from the source

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. 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 Quantity: 13, 133 (3,408 US; 9,725 ROW) Lot/code info: 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 22

UPC codes

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

Source

Official record: FDA (Device enforcement) ↗

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