Events

Oarm O2 Imaging System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Navigation, Inc.-Littleton 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79272
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0927-2018
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161803
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Interventional fluoroscopic x-ray system - Product Code OWB
  • 원인
    During servicing of certain internal components of the o-arm o2 surgical imaging system, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.
  • 조치
    Medtronic sent an Medical Device Safety Notice dated September 29, 2017, reminding them to follow servicing procedures. In addition, Medtronic is developing a retrofit service kit that will be installed during the next service visit for each O-arm O2 system, no later than 15 months from service kit availability. The user can continue to use the system prior to installation of the service kit. Medtronic will also implement the same changes in the manufacturing process for newly manufactured O-arm O2 systems. For further questions, please call (978) 698-6000.

Device

Oarm O2 Imaging System
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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.
  • Manufacturer
    Medtronic Navigation, Inc.-Littleton

Manufacturer

Medtronic Navigation, Inc.-Littleton
  • 제조사 주소
    Medtronic Navigation, Inc.-Littleton, 300 Foster St, Littleton MA 01460-2017
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “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