Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; 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 FD20/20 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.)

Detalles del retiro

Fabricante

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Distribuidor

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.

Lote

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 Serial Numbers 101 102 103 107 123 124 132 133 140 15 157 163 168 169 170 171 172 173 23 234 237 255 267 268 269 270 275 279 308 319 324 325 33 332 344 345 358 362 375 380 57 58 59 76 82 83 84 87 , 722027 - UDI-DI 00884838054196 or 00884838059191 Serial Numbers 1 106 107 112 116 120 123 127 133 134 152 153 156 164 169 174 175 178 179 183 202 203 209 216 222 230 240 241 246 255 263 265 266 284 29 305 306 319 32 332 342 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 1007 1132 1210 1221 1276 1420 1439 1444 1446 1461 1469 1476 1507 1588 1589 1659 1661 1705 1720 1812 1830 1848 1870 1875 1913 1922 1942 1955 2008 2126 2147 2199 2203 2323 2404 2425 45 468 518 559 638 673 675 683 722 723 774 804 806 810 886 904 , 722012 - UDI-DI 00884838059054, 00884838059191, or 00884838059207 Serial Numbers 100 1002 1003 1005 101 1017 1020 1023 1027 103 1032 1033 1034 1036 1037 1038 1045 1047 1054 1058 1062 1083 1091 1092 1098 1099 1100 1102 1104 1105 1113 1115 1116 1117 1119 114 1141 1148 1167 1189 1192 1195 1207 1210 1211 1212 1216 1219 1226 1239 1240 1249 1250 1254 126 1265 1269 1270 1271 1272 1279 1282 1285 1286 1293 1294 1305 1316 1317 1321 1324 1328 1334 1335 1337 1344 1345 1354 1357 1359 1396 1399 1404 1405 1406 1407 1408 141 1422 1426 1440 1441 1442 1446 1447 1455 1456 1461 1467 1473 1477 1478 1497 1506 1507 1508 1512 1513 1515 1516 1527 1531 1532 1533 1537 1538 1542 1545 1549 1550 1558 1559 1560 1561 1570 1581 1586 1587 1588 1589 1590 1593 1594 1595 1596 1597 1598 1599 1606 1607 1608 1610 1611 1613 1616 1617 1622 1625 1630 1635 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 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 1868 1869 1871 1889 1894 1895 1900 1904 1906 1908 1916 1918 1919 1922 1923 1924 1941 1943 1945 1946 1947 1948 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 2081 2085 2086 2092 2133 2134 2135 2136 2138 2145 2146 2148 2149 2150 2151 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 2353 2454 248 2484 2508 2509 2511 2512 2514 2515 2516 2518

Clasificación de riesgo

Class II

Área (FDA)

device

País

Netherlands