Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.
Reason for recall: Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications. Distribution: U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, Ho Quantity: 1,225 total USMs Lot/code info: da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200 Part Number: 380647 UDI-DI Code: 00886874114216 Serial Numbers: RSK8062 RSK8104 RSK8128 RSK8130 RSK8134 RSK8135 RSK8136 RSK8137 RSK8138 RSK8139 RSK8143 RSK8144 RSK8146 RSK8147 RSK8148 RSK8149 RSK8152 RSK8153 RSK8154 RSK8158 RSK8159 RSK8160 RSK8162 RSK8163 RSK8164 RSK8166 RSK8167 RSK8168 RSK8170 RSK8172 SK0050 SK0055 SK0090 SK0091 SK0101 SK0112 SK0128 SK0137 SK0141 SK0151 SK0153 SK0160 SK0169 SK0211 SK0213 SK0221 SK0280 SK0285 SK0329 SK0382 SK0383 SK0393 SK0395 SK0420 SK0429 SK0433 SK0499 SK0511 SK0518 SK0540 SK0548 SK0563 SK0607 SK0612 SK0618 SK0636 SK0644 SK0661 SK0662 SK0710 SK0739 SK0749 SK0751 SK0765 SK0783 SK0805 SK0811 SK0827 SK0852 SK0866 SK0875 SK0893 SK0912 SK0937 SK0957 SK0968 SK0976 SK0980 SK1008 SK1009 SK1040 SK1063 SK1092 SK1101 SK1102 SK1118 SK1136 SK1143 SK1182 SK1187 SK1211 SK1249 SK1251 SK1261 SK1273 SK1290 SK1322 SK1341 SK1382 SK1385 SK1405 SK1423 SK1428 SK1436 SK1450 SK1470 SK1482 SK1535 SK1565 SK1571 SK1574 SK1581 SK1597 SK1607 SK1634 SK1635 SK1639 SK1651 SK1686 SK1758 SK1784 SK1808 SK1845 SK1863 SK1880 SK1926 SK1936 SK1967 SK1990 SK1993 SK2101 SK2119 SK2132 SK2144 SK2194 SK2274 SK2287 SK2333 SK2403 SK2404 SK2413 SK2454 SK2486 SK2504 SK2508 SK2512 SK2520 SK2538 SK2539 SK2540 SK2541 SK2573 SK2575 SK2654 SK2658 SK2667 SK2748 SK2764 SK2765 SK2798 SK2809 SK2845 SK2923 SK2988 SK3000 SK3182 SK3277 SK3291 SK3294 SK3393 SK3413 SK3504 SK3518 SK3545 SK3554 SK3602 SK3645 SK3727 SK3763 SK
00886874114216
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.