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FDA (Device enforcement)Recalled 2024-01-02class ii

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Mode

Hazard

Dual In-Line Memory Modules (DIMMs) 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: Dual In-Line Memory Modules (DIMMs) 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: 5,500 (1,681 US; 3,819 ROW) Lot/code info: Allura Xper FD10 722003 - no UDI Serial Numbers 105 1181 1209 1349 1435 1472 1529 1555 1594 1700 1719 1788 285 472 482 912 913 928 , 722010 - UDI-DI 00884838059030 or 00884838059191 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 1369 1370 1373 1391 1395 1396 1397 1398 1424 1436 1440 1442 145 170 177 191 209 214 252 314 33 337 343 344 39 414 43 467 468 477 480 500 527 572 585 604 609 61 611 624 646 65 651 656 662 667 668 670 679 68 714 728 754 755 763 767 791 794 809 818 830 838 839 873 882 896 902 905 914 917 920 921 931 932 937 939 946 965 968 970 976 979 986 987 992 999 , 722026 - UDI-DI 00884838054189 Serial Numbers 100 101 102 1050 1052 1068 109 11 110 112 114 115 116 117 1205 121 1210 122 130 142 151 155 156 185 190 191 192 204 215 220 221 223 233 234 244 245 253 258 259 265 284 297 319 323 324 335 344 368 370 374 378 381 391 394 396 400 431 432 436 444 458 462 465 484 485 512 522 531 543 544 558 559 560 561 562 563 600 601 602 604 605 612 614 617 618 622 627 633 634 646 648 653 663 664 683 713 716 725 73 731 738 74 75 765 774 78 781 786 79 796 805 826 832 841 845 87 877 878 908 93 931 959 965 966 967 98 985 99 ; Allura Xper FD10/10 722005 - no UDI Serial Numbers 261 329 344 456 49 523 63 , 722011 - no UDI Ser

UPC codes

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

Source

Official record: FDA (Device enforcement)

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

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