Medtronic Navigation, Inc.-Littleton

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Description

  • Dirección del fabricante
    Medtronic Navigation, Inc.-Littleton, 300 Foster St, Littleton MA 01460-2017
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA
  • 2 Event

2 dispositivos en la base de datos

  • Modelo / Serial
    Serial Numbers: 1065R C0875 C0876 C0877 C0878 C0879 C0930 C0931 C0932 C0933 C0934 C0935 C0936 C0962 C0963 C0964 C0965 C0966 C0967 C0973 C0974 C0977 C0978 C0981 C0982 C0985 C0986R C0989 C0990 C0993 C0994R C0997 C0998 C1001 C1002 C1007 C1010 C1011 C1013 C1015 C1016 C1021 C1022 C1025 C1027 C1029 C1031 C1033 C1035 C1036 C1037 C1038 C1040 C1042 C1043 C1044 C1045 C1046 C1047 C1050 C1051 C1052 C1053 C1054 C1056 C1057 C1059 C1060 C1061 C1062 C1063 C1066 C1067 C1068 C1069 C1070 C1071 C1073 C1074 C1075 C1076 C1077 C1079 C1080 C1081 C1083 C1084 C1085 C1086 C1087 C1089 C1090 C1091 C1092 C1094 C1096 C1097 C1098 C1099 C1101 C1103 C1104 C1107 C1108 C1109 C1110 C1113 C1116 C1117 C1121R C1123 C1124 C1125 C1127 C1128 C1129 C1131 C1132 C1133 C1134 C1135 C1139 C1140 C1141 C1142 C1143 C1144 C1145 C1146 C1147 C1148 C1149 C1151 C1152 C1153 C1154 C1156 C1157 C1158 C1160 C1161 C1162 C1163 C1165 C1166 C1167 C1168 C1169 C1170 C1171 C1172 C1173 C1174 C1175 C1176 C1177 C1178 C1179 C1180 C1181 C1182 C1185 C1186 C1187 C1188 C1189 C1191 C1192 C1193 C1194 C1195 C1197 C1198 C1199 C1200 C1201 C1203 C1204 C1205 C1206 C1208R C1209 C1210 C1211 C1212 C1214 C1216 C1217 C1218 C1219 C1220 C1221 C1222 C1223 C1224 C1225 C1227 C1228 C1229 C1230 C1231 C1232 C1233 C1235 C1236 C1237 C1238 C1240 C1241 C1242 C1243R C1244 C1245 C1246 C1247 C1249 C1251 C1252 C1253 C1254 C1255 C1256 C1258 C1260 C1261 C1262 C1263 C1264 C1265 C1266 C1267 C1268 C1269 C1270 C1271 C1274 C1275 C1276 C1277 C1278 C1279 C1280 C1281 C1282 C1283 C1284 C1285 C1286 C1288 C1289 C1290 C1291 C1292 C1293 C1294 C1295 C1296 C1297 C1298 C1299 C1300 C1301 C1302 C1303 C1304 C1305 C1306 C1307 C1308 C1309 C1311 C1313 C1314 C1315 C1316 C1317 C1318 C1319 C1320 C1321 C1322 C1323 C1324 C1325 C1326 C1327 C1328 C1329 C1330 C1331 C1332 C1334 C1335 C1336 C1337 C1338 C1339 C1340 C1341 C1342 C1343 C1344 C1345 C1346 C1347 C1348 C1349 C1350 C1351 C1352 C1353 C1354 C1355 C1356 C1357 C1358 C1359 C1360 C1361 C1362 C1363 C1364 C1365 C1366 C1367 C1368 C1369 C1370 C1371 C1372 C1373 C1374 C1375 C1376 C1377 C1378 C1379 C1380 C1381 C1382 C1383 C1384 C1385 C1386 C1387 C1388 C1389 C1390 C1391 C1392 C1393 C1394 C1395 C1396 C1397 C1398 C1399 C1400 C1401 C1402 C1403 C1404 C1405 C1406 C1407 C1408 C1409 C1410 C1411 C1412 C1413 C1414 C1415 C1416 C1417 C1418 C1419 C1420 C1421 C1422 C1423 C1424 C1425 C1426 C1427 C1428 C1429 C1430 C1431 C1432 C1433 C1434 C1435 C1436 C1437 C1438 C1439 C1440 C1441 C1442 C1443 C1444 C1446 C1447 C1448 C1449 C1450 C1452 C1453 C1454 C1455 C1457 C1458 C1459 C1460 C1461 C1462 C1463 C1464 C1465 C1467 C1468 C1469 C1470 C1471 C1472 C1473 C1474 C1475 C1476 C1477 C1478 C1479 C1481 C1482 C1483 C1484 C1485 C1486 C1488 C1489 C1490 C1491 C1492 C1493 C1494 C1495 C1497 C1498 C1499 C1500 C1501 C1502 C1503 C1504 C1505 C1506 C1507 C1508 C1509 C1510 C1511 C1512 C1513 C1514 C1515 C1516 C1517 C1518 C1519 C1520 C1521 C1522 C1523 C1524 C1525 C1526 C1527 C1528 C1529 C1530 C1531 C1532 C1533 C1534 C1535 C1536 C1537 C1538 C1539 C1540 C1541 C1542 C1543 C1544 C1545 C1546 C1547 C1548 C1549 C1550 C1551 C1552 C1553 C1554 C1555 C1556 C1557 C1558 C1559 C1560 C1561 C1562
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV., and to the countries of : Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Luxembourg, Martinique, Mexico, Netherlands, New Zealand, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 || The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
  • Modelo / Serial
    Serial Numbers: B14070845 B13050682 B13080716 B14010771 B14010779 B14020790 B14040813 B15020929 B14020789 B15101034 B15101041 B16011100 B16021102 B15060987 B14110904 B16021105 B16021106 B15020941 B15050972 B15030949 B16021111 B15091028 B14010774 B14030797 B16021112 B16031114 B16041137 B16061190 B15010926 B15060988 B16061196 B13080721 B16071207 B16071213 B13080722 B16071215 B16081234 B17101333 B14030803 B14040814 B17101445 B14040817 B17071466 B17121536 B14050830 B17121544 B14050829 B14070857 B14080865 B14090881 B13080718 B14050824 B14060833 B13060683 B13060698 B15030948 B15050971 B14010781 B14030802 B14030805 B15121072 B16011082 B13090723 B13120770 B14010772 B13120764 B14010776 B14030785 B14110898 B14120906 B14030807 B14050823 B14060832 B14060834 B16111259 B15020925 B15091014R B17031257 B13080717 B14010775R B15091020 B14040811 B14050822 B14070840 B15030946 B14030808 B13080724 B14070851 B14020773 B14120905 B14020794 B14080860 B15010922 B15020943 B15030951 B15060976 B15060984 B15070999 B15091023 B15091032 B14110897R B14040810 O-Arm 831 O-arm 842 B14070854 B14090883 B14120909 B15010921 B15030954 B15091024 B15030952 B14080871 B14090872 B14090880 B14120908 B14120913 B15020928 B15030953 B15071004 B15091026 B15101039 B14080859 B15081008 B15091030 B15121049 B16011095 B14090873 B15111055 B15121064 B14080869 B14020786 B14070852 B14100887 B14110903 B14120917 B15010920 B15020927 B15020940 B14020792 B14100891 B14100893 B14120910 B15091018 B14020788 B14060836 B15040961 B16031115 B14040819 B14110899 B15040960 B15091019 B14090885 B15020942 B14050827 B14080867 B14070835 B15030955 B15040959 B14090882 B13120765 B14070846 B16051155 B14120915 B15071000 B14010777 B14090884 B14100886 B14100894 B14110902 B15050975 B16041138 B14110896 B15030950 B14010769 B14090863 B15121058 B13080720 O-arm 804 B14070839 B15020937 B15040958 B15091017 B14110901 B13120766 B14080862 B14080864 B14100895 B14120907 B14120912 B15010919 B15020939 B13120763 B13120768 B14020795 B14050826 B14070847 B14070849 B14080861 B14080866 B14100888 B15030947 B15060980 B15070992 B15081005 B15091012 B16031120 B16041136 B13090729 B14100889 B14100890 B17011287 B14120916 B13080715 B16081226 B16101239 B14010780 B16051159 B15030945 B14030796 B14040816 B14050821 B13050681 B13050685 B14030799 B15020938 B16041150 B14030800 B14090874 B14120911 B14030801 B14120918 B16031126 B15010923 B16061164 B14030787 B15050968 B14020793 B14030798 B14060838 B13080711 B13080719 B14030806 B15071003 B14050815 B15010924 B13070710 B14010782 B14020784 B14070843 B14010778 B14040812 B14040820 B14050828
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Puerto Rico. Distributed in Algeria, Australia, Chile, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Jordan, Lebanon, Sri Lanka, New Zealand, Nicaragua, Poland, Portugal, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom.
  • Descripción del producto
    O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM Bl70000028120R SYS 120V RWK, Product Number: Bl70000028120R (UDI: 00643169353459); (4) Model: BASE OARM Bl70000028230 SYS 230V, Product Number: Bl70000028230 (UDI: 00643169353992); (5) BASE OARM Bl70000028230R SYS 230V RWK, Product Number: Bl70000028230R (UDI: 00643169354081) || Product Usage: || The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm Imaging System is compatible with certain Image Guided Surgery Systems.

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Más información acerca de la data acá

  • Dirección del fabricante
    Medtronic Navigation, Inc.-Littleton, 300 Foster Street, Littleton MA 01460-2017
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA