Class 2 Device Recall da Vinci Si/X/Xi Surgical System

• Date Initiated by Firm: July 16, 2018
• Create Date: September 26, 2018
• Recall Status: Terminated on October 05, 2023
• Recall Number: Z-3254-2018
• Recall Event ID: 80947
• 510(K)Number: K171294 K131861 K081137
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units; ; The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.
• Code Information: Model Name: Model Number: UDI Number: da Vinci Si Surgical System IS3000 00886874110744 System/Console Name/Number: SH2433 SH2433 SH2406 SH2407 RSH0112 RSH0201 SH0948 SH2441 SH2409 SH2430 SH2412 SH2419 SH2409 SH2430 SH2441 SH2449 SH2446 SH2448 SH2402 SH2418 SH2421 SH2418 SH2404 SH2442 SH2421 SH2423 SH2425 SH2423 SH2426 SH2426 SH2442 SH2420 SH2415 SH2444 SH2422 SH2444 SH2435 SH2443 SH2431 SH2437 SH2447 SH2443 SH2445 SH2434 SH2450 RSH0159 RSH0137 RSH0140 RSH0165 RSH0204 RSH0167 RSH0166 RSH0180 RSH0181 RSH0205 RSH0229 RSH0155 RSH0163 RSH0160 RSH0170 SH2413 SH2413 SH2413 SH2408 RSH0210 SH2440 SH2410 SH2424 SH1681 RSH0126 SH0185 RSH0082 RSH0009 RSH0164 RSH0161 RSH0162 RSH0176 SC0042 SH1641 SH2038 SH0215 RSH0043 SH1133 RSH0209 SH0473 SH1786 RSH0120 SH2432 SH0272 SH0232 SC0045 SH0261 SH0925 SH0157 SH2436 SH2436 SH2438 da Vinci X Surgical System IS4200 00886874110683 System/Console Name/Number SL0028 SL0044 SL0015 SL0068 SL0132 SL0138 SL0052 SL0010 SL0008 SL0008 SL0074 SL0073 SL0101 SL0063 SL0094 SL0066 SL0081 SL0072 SL0069 SL0102 SL0100 SL0126 SL0126 SL0062 SL0061 SL0062 SL0136 SL0017 SL0041 SL0040 SL0039 SL0130 SL0091 SL0060 SL0022 SL0013 SL0012 SL0022 SL0059 SL0157 SL0065 SL0067 SL0133 SL0133 SL0113 SL0080 SL0076 SL0080 SL0047 SL0087 SL0079 SL0029 SL0050 SL0131 SL0042 SL0016 SL0057 SL0093 SL0129 SL0034 SL0037 SL0032 SL0090 SL0121 SL0082 SL0036 SL0035 SL0020 SL0019 SL0048 SL0021 SL0018 SL0043 SL0053 SL0055 SL0046 SL0038 SL0049 SL0127 SL0128 SL0104 SL0141 SL0056 SL0075 SL0106 SL0088 SL0117 SL0134 SL0122 SL0158 SL0158 SL0120 SL0118 SL0135 SL0124 SL0125 da Vinci Xi Surgical System IS4000 00886874110690 00886874110713 System/Console Name/Number: SK0241 SK1145 SK1143 SK1151 SK1151 SK1291 SK1186 SK1292 SK1297 SK1292 SK1449 SK0583 SK0312 SK1090 SK1185 SK1191 SK1521 SK1521 SK1554 SK1226 SK1306 SK1304 SK1683 SK1734 SK1423 SK1601 SK1602 SK1421 SD0009 SK1149 SK1147 SK0972 SK1327 SK1743 SK1743 SK1747 SK1083 SK1083 SK1252 SK1378 SK1252 SK1325 SK1173 SK1178 SK1173 SK1360 SK1179 SK1325 SK1309 SK1198 SK1179 SK1344 SK1309 SK1453 SK1406 SK1560 SK1453 SK1406 SK1560 SK1717 SK1592 SK1717 SK1737 SK1688 SK1688 SK1132 SK1308 SK1208 SK1645 SK1647 SK1646 SK1766 SK1764 SK1765 SK1462 SK1190 SK1278 SK1434 SK1434 SK1511 SK1684 SK0781 SK1714 SK1714 SK1684 SK1698 SK1106 SK1106 SK1166 SK1271 SK1271 SK1164 SK1164 SK1402 SK1538 SK1414 SK1414 SK1402 SK1643 SK1643 SK1322 SK1310 SK1242 SK1242 SK1544 SK1544 SK1401 SK1121 SK1125 SK1496 SK1142 SK1228 SK1354 SK1499 SK1497 SK1649 SK1649 SK1648 SK1648 SK1059 SK1161 SK1148 SK1148 SK1293 SK1294 SK1162 SK1232 SK1294 SK1303 SK1303 SK1161 SK1727 SK1727 SK1723 SK1586 SK1585 SK1723 SK1725 SK1724 SK1199 SK1197 SK1343 SK0647 SK1131 SK1332 SK1385 SK1290 SK1040 SK1289 SK1260 SK1277 SK1260 SK1324 SK1326 SK1296 SK1385 SK1487 SK1487 SK1486 SK1537 SK1473 SK1445 SK1446 SK1457 SK1472 SK1395 SK1435 SK1529 SK1542 SK1542 SK1632 SK1605 SK1605 SK1570 SK1591 SK1583 SK1580 SK1563 SK1579 SK1583 SK1566 SK1574 SK1650 SK1580 SK1632 SK1569 SK1771 SK1773 SK1771 SK1174 SK1174 SK1231 SK1450 SK1443 SK1451 SK1485 SK1721 SK1702 SK1557 SK1689 SK1644 SK1644 SK1488 SK1436 SK1844 SK1844 SK1775 SK1775 SK1227 SK1230 SK1561 SK1572 SK1573 SK1578 SK1730 SK1532 SK1340 SK1340 SK1651 SK1237 SK1140 SK1238 SK1176 SK1429 SK1600 SK1577 SK1797 SK1124 SK1144 SK0978 SK0977 SK0979 SK1064 SK1100 SK1002 SK1099 SK1064 SK1167 SK1233 SK1265 SK1224 SK1163 SK0930 SK1420 SK1275 SK1452 SK1416 SK1206 SK1251 SK1195 SK1207 SK1236 SK1220 SK1258 SK1259 SK0542 SK1263 SK1273 SK1203 SK1217 SK1454 SK1218 SK1146 SK1156 SK1146 SK1273 SK1334 SK1211 SK1249 SK1285 SK1396 SK1246 SK1181 SK1135 SK1235 SK1158 SK1216 SK1158 SK1215 SK1258 SK1093 SK1126 SK1097 SK0977 SK1202 SK1088 SK1117 SK1116 SK1115 SK1119 SK1108 SK1112 SK1099 SK1078 SK1074 SK1126 SK1075 SK1130 SK1119 SK1092 SK1072 SK1071 SK1113 SK1116 SK1114 SK1094 SK1103 SK1177 SK1316 SK1189 SK1210 SK1222 SK1212 SK1139 SK1193 SK1168 SK1194 SK1286 SK1159 SK1342 SK1286 SK1352 SK1348 SK1167 SK1201 SK1213 SK1180 SK1196 SK0203 SK1188 SK1171 SK1214 SK1634 SK1195 SK1175 SK1175 SK1171 SK1160 SK1203 SK1363 SK1319 SK1337 SK1280 SK1284 SK0619 SK1214 SK1169 SK1223 SK1204 SK1177 SK1209 SK1170 SK1182 SK1246 SK1160 SK1234 SK1221 SK1210 SK1204 SK1170 SK1240 SK1282 SK1205 SK1155 SK1155 SK1073 SK1229 SK1295 SK1256 SK1241 SK1250 SK1264 SK1245 SK1243 SK1253 SK1218 SK1241 SK1248 SK1247 SK1244 SK1274 SK1272 SK1243 SK1393 SK1262 SK1263 SK0277 SK1109 SK1248 SK0345 SK1256 SK1500 SK1333 SK1369 SK1351 SK0298 SK1255 SK1461 SK1359 SK0893 SK1444 SK1254 SK1321 SK1320 SK1288 SK1353 SK1330 SK1270 SK1339 SK1337 SK1311 SK1350 SK1307 SK1267 SK1239 SK1257 SK1315 SK1335 SK1281 SK1269 SK1268 SK1270 SK1279 SK1266 SK1374 SK1317 SK1283 SK1285 SK0249 SK1261 SK1279 SK1266 SK1282 SK1299 SK1298 SK1358 SK1295 SK1329 SK1331 SK1329 SK1312 SK1346 SK0273 SK1422 SK1341 SK1359 SK1345 SK1353 SK1372 SK1316 SK1543 SK1313 SK1347 SK1338 SK1288 SK1300 SK1168 SK1257 SK1357 SK1287 SK1356 SK1328 SK1305 SK1314 SK1318 SK1314 SK1336 SK1305 SK1339 SK1367 SK1370 SK1366 SK1372 SK1397 SK1382 SK1504 SK1394 SK1373 SK1387 SK1362 SK1287 SK1361 SK1368 SK1365 SK1349 SK1371 SK1386 SK1494 SK1388 SK1368 SK1392 SK1468 SK1394 SK1475 SK1495 SK1391 SK1383 SK1491 SK1398 SK1380 SK1390 SK1235 SK1392 SK1491 SK1364 SK1381 SK1447 SK1381 SK1409 SK1383 SK1403 SK1376 SK1869 SK1405 SK1481 SK1424 SK1379 SK1490 SK1759 SK1376 SK1510 SK1377 SK1338 SK1589 SK1438 SK1433 SK1437 SK1428 SK1442 SK1618 SK1109 SK1404 SK1484 SK1425 SK1408 SK1400 SK1471 SK1441 SK1399 SK1448 SK1432 SK1459 SK1474 SK1422 SK1424 SK1416 SK1637 SK1419 SK1407 SK1455 SK1504 SK1463 SK1477 SK1452 SK1417 SK1518 SK1530 SK1502 SK0745 SK1482 SK1539 SK1515 SK1425 SK0573 SK1498 SK1524 SK1519 SK1527 SK1427 SK1513 SK1474 SK1512 SK1458 SK1533 SK1540 SK1534 SK1526 SK1440 SK1722 SK1520 SK1524 SK1456 SK1431 SK1482 SK1520 SK1455 SK1431 SK1516 SK1526 SK1512 SK1525 SK1489 SK1618 SK1447 SK1415 SK1432 SK1448 SK1415 SK1501 SK1464 SK1439 SK1459 SK1433 SK1492 SK1412 SK1480 SK1481 SK1509 SK1494 SK1476 SK1479 SK1478 SK1483 SK1463 SK1465 SK1493 SK1469 SK1465 SK1469 SK1503 SK1594 SK1514 SK1508 SK1507 SK1506 SK1470 SK1467 SK1467 SK1506 SK1492 SK1470 SK1505 SK1517 SK1565 SK1552 SK1528 SK1564 SK1549 SK1541 SK1700 SK1536 SK1550 SK1568 SK1548 SK1531 SK1388 SD0010 SK1428 SK1535 SK1595 SK1545 SK1517 SK1624 SK1654 SK1604 SK1612 SK1671 SK1676 SK1635 SK1638 SD0013 SK1653 SK1588 SK1611 SK1587 SK1558 SK1663 SK1593 SK1587 SK1630 SK1685 SK1631 SK1596 SK1619 SK1603 SK1686 SK1623 SK1556 SK1708 SK0297 SK1597 SK1610 SK1617 SK1626 SK1620 SK1656 SK1639 SK1707 SK1658 SK1657 SK1627 SK1629 SK1631 SK1705 SK1748 SK1662 SK1636 SK1659 SK1635 SK1663 SK1625 SK1612 SK1633 SK1619 SK1575 SK1202 SK1555 SK1660 SK1625 SK1558 SK1575 SK1568 SK1567 SK1599 SK1553 SK1546 SK1555 SK1595 SK1549 SK1582 SK1551 SK1553 SK1598 SK1598 SK1571 SK1483 SK1628 SK1655 SK1642 SK1562 SK1608 SK1652 SK1581 SK1653 SK1611 SK1640 SK1638 SK1590 SK1621 SK1654 SK1672 SK1609 SK1621 SK1735 SK1693 SK1731 SK1667 SK1740 SK1716 SK1699 SK1740 SK1666 SK1664 SK1728 SK1692 SK1692 SK1706 SK1696 SK1739 SK1732 SK1695 SK1715 SK1695 SK1849 SK1710 SK1677 SK1735 SK1732 SK1739 SK1710 SK1697 SK1691 SK1706 SK1098 SK1719 SK1652 SK1617 SK1718 SK1709 SK1694 SK1678 SK1682 SK1672 SK1703 SK1674 SK1704 SK1671 SK1668 SK1665 SK1668 SK1665 SK1675 SK1685 SK1742 SK1680 SK1681 SK1673 SK1729 SK1762 SK1760 SK1754 SK1729 SK1868 SK1868 SK1751 SK1763 SD0012 SK1749 SK1748 SK1752 SK1746 SK1750 SK1746 SK1738 SK1744 SK1754 SK1741 SK1733 SK1720 SK1749 USG313
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd Bldg 101; Sunnyvale CA 94086-5304
• For Additional Information Contact: Mark E. Johnson; 408-523-2100
• Manufacturer Reason for Recall: Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 07/16/2018, the firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" Notification to customers vi a Federal Express and email, and posted on the US Customer Portal . The letter described the product, problem and actions to be taken. The notice states to note that solely having the affected power supply module does not mean the system will encounter a power loss event. To encounter the related power loss scenario above, both of the following two (2) conditions must be met. 1. The system contains the affected power supply. 2. A failure of one of the power supply modules is experienced. The notice instructs customers to follow their specific system user manuals for guidance on how to proceed in the scenario where a loss of power is experienced on a console or cart. If the failure occurs to the Surgeon Console and the site has a dual console set up, the site may continue with the planned surgery robotically with one console. To correct this issue, an Intuitive Surgical Representative will schedule a site visit to provide a replacement RMGSP. The notice also instructs customer/user to, please take the following actions to ensure all affected personnel are fully informed of this Field Safety Notice. Forward this letter to your Risk Manager, OR Director, Purchasing, Biomedical Engineering staff, and other members of your medical staff who perform da Vinci procedures. 1. You may continue using the system until the Intuitive Surgical representative replaces the unit. Please follow your specific system user manuals for guidance on how to proceed in the scenario where a loss of power is experienced on a console or cart. 2. Ensure surgeons and patient side assistants using the da Vinci Si, Xi, and X Surgical System read and understand the contents of this letter. 3. Inform affected personnel when corrective action has been completed. 4. Complete the attached Acknowledgement Form and return it via fax or email to Intuitive Surgical per the instr
• Quantity in Commerce: 1,014 currently installed on systems
• Distribution: Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, Norway, New Zealand, Romania, Russia, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, and Venezuela.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.