FDAFDA · Food and drugs·Recall number Z-0063-2015
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
Published October 22, 2014 · Recall initiated: September 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Lot
- Part Number: PN 410322-04, -05 Serial Numbers: SH1484 SH1879 SH1875 SH1485 USG332 SH0561 USG803 SH1406 SH1405 SH0034 SH0554 SH0554 USG160 USG575 SH0908 SH2066 SH1455 SH0975 SH1475 SH1168 SH1552 SH0608 SH0608 SH1756 SH1716 USG071 USG038 SH0607 SH1590 SH1686 SH1639 SH1688 SH1740 SH1932 USG323 SH1944 USG286 SH1945 SH2022 SH2085 SH1108 SH2047 USG257 USG435 USG183 SH2079 USG035 USG144 USG647 SH1590 USG641 SH0087 USG580 SH0389 USG106 SH1642 USG351 SH0280 SH1963 SH0566 USG551 USG566 USG636 SH2076 USG122 USG163 SH0084 USG706 USG563 SH0252 SH1494 SH1249 SH1588 SH1495 USG103 USG484 SH0329 SH1980 USG060 USG421 USG364 SH0148 USG398 SH0412 SH0881 SH1687 SH2154 SH1998 SH1802 SH1863 SH1939 SH2100 SH2128 SH0572 SH0208 SH1159 SH1592 SH0273 SH2143 SH1297 SH1852 SH2014 SH1941 SH2009 SH2015 SH2013 SH2027 SH2116 SH2056 SH2012 SH2161 SH2193 SH2209 SH0467 SH0238 USG605 SH1962 SH1757 SH1874 SH1938 SH1607 SH1854 SH2096 SH2070 SH2082 SH2095 USG560 USG279 SH1608 USG726 SH1114 SH1614 SH2054 USG116 USG277 USG345 SH2179 SH2207 SH0328 SH1901 SH1940 SH0733 SH0658 SH0062 SH0357 SH1691 SH0893 USG129 SH1565 SH2121 USG418 SH1806 USG127 USG159 USG438 SH1118 SH0030 SH0332 SH0586 SH0819 SH0435 USG445 SH0108 USG156 SH0436 SH0883 SH0950 SH1096 SH1336 SH1369 SH0306 SH0640 SH0481 SH0453 SH1282 SH1177 SH0341 SH0850 SH1192 SH1293 SH0214 SH0319 SH0078 SH0741 SH0949 SH1391 SH1372 SH1322 SH1362 SH1401 SH1353 SH0098 SH0592 SH1027 SH0181 USG098 USG639 SH0212 SH1375 SH1359 SH1213 SH1337 SH0582 SH1332 SH0802 SH1396 SH0475 SH1394 SH1338 SH0438 SH1367 SH1409 SH1348 SH0829 SH1395 SH1376 USG542 SH0118 SH1389 SH1142 SH1402 SH0379 SH1399 SH1294 SH0830 SH1287 SH1398 SH1335 SH0394 SH1392 SH0483 SH1383 SH1347 SH1325 SH0321 USG623 SH0115 SH0770 SH1412 SH1343 USG334 SH0599 SH1410 SH0847 SH0962 SH1466 SH0168 SH0415 SH0159 SH1413 SH0041 SH1446 SH0418 SH1427 SH0318 SH0921 SH0723 SH1451 SH1022 SH0613 USG114 SH0314 SH1504 SH0476 SH0142 SH1432 SH0729 SH0722 USG221 USG515 SH0837 SH1438 SH0299 SH0609 SH0966 SH1109 SH0169 USG533 USG558 SH0417 SH1512 SH1426 SH1276 SH1448 SH1323 SH1247 SH1460 SH0755 SH1197 SH1344 SH1334 SH1331 SH0052 SH0275 SH0986 SH0753 SH0386 SH1273 USG170 SH1364 SH0486 SH0919 SH1457 USG311 SH1515 SH1518 SH1513 SH1441 SH1373 SH1505 SH1471 USG059 SH1197 SH1417 USG696 SH1415 SH1445 SH0767 SH1487 SH1193 SH1124 SH1194 SH0420 SH1093 SH0423 SH0898 SH0413 SH0165 SH1414 SH0863 SH1295 USG074 SH0768 SH0849 SH1425 SH1418 SH1440 SH1506 USG649 SH1431 SH1182 SH1162 SH0466 SH1430 USG2007 SH0920 SH0641 SH0548 SH1462 SH1496 SH1472 SH0314 SH0742 SH1488 SH1489 SH0584 SH1478 SH1459 SH1508 USG135 SH1453 SH0575 SH1491 USG565 SH1477 SH1467 SH1549 SH1191 SH0248 SH1521 SH0843 SH1483 SH1524 SH1449 SH1479 USG498 SH1436 SH1234 SH1437 SH1447 SH0861 USG248 USG343 SH1014 SH0489 SH1433 SH0739 SH0983 SH1469 SH1261 USG2011 SH1529 SH0838 SH1429 SH1055 SH1497 SH1498 SH1490 SH1510 SH1511 SH1305 SH1517 SH0101 USG056 SH0130 SH0325 SH0784 SH1532 SH0109 SH0934 SH1288 SH1526 SH0152 SH1144 SH0485 SH0039 SH1223 SH0700 SH0241 SH0970 SH0576 SH1545 USG567 SH1326 SH1069 SH1351 SH0951 SH0022 SH0297 SH0922 SH0792 SH1525 USG172 SH1576 USG631 USG700 SH1566 SH1324 SH1465 USG412 SH0281 SH0725 SH0716 SH1147 USG342 SH1530 SH0751 SH0673 USG440 SH0025 SH0674 SH1008 SH1363 SH0149 SH1522 SH1575 SH0266 SH1553 USG048 SH1146 SH1136 SH0985 SH1534 SH1452 USG469 SH1268 SH1540 USG433 SH0113 USG707 SH0984 SH1531 SH0183 SH1034 SH1251 SH1533 SH1128 SH0368 SH1553 SH0431 SH1578 SH1258 SH1679 SH1539 USG643 SH0903 SH1188 SH0904 SH0685 SH0633 USG132 SH0786 SH1556 SH1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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