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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Xi/X Surgical System

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  Class 2 Device Recall da Vinci Xi/X Surgical System see related information
Date Initiated by Firm February 10, 2023
Date Posted March 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-1293-2023
Recall Event ID 91503
510(K)Number K131861  K171294  
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Product da Vinci Xi Surgical System Model IS4000

da Vinci X Surgical System Model IS4200
Code Information 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 SK3799 SK3893 SK3922 SK3941 SK3956 SK4102 SK4178 SK4181 SK4207 SK4246 SK4250 SK4321 SK4328 SK4400 SK4416 SK4501 SK4562 SK4576 SK4674 SK4691 SK4692 SK4769 SK4802 SK4819 SK4825 SK4862 SK4906 SK4966 SK4987 SK5011 SK5033 SK5063 SK5098 SK5108 SK5129 SK5149 SK5202 SK5316 SK5322 SK5351 SK5447 SK5530 SK5547 SK5553 SK5554 SK5555 SK5561 SK5564 SK5567 SK5568 SK5570 SK5575 SK5576 SK5579 SK5580 SK5582 SK5583 SK5585 SK5586 SK5587 SK5588 SK5590 SK5591 SK5592 SK5593 SK5594 SK5596 SK5598 SK5599 SK5600 SK5601 SK5602 SK5604 SK5608 SK5609 SK5610 SK5612 SK5613 SK5614 SK5615 SK5617 SK5618 SK5619 SK5622 SK5623 SK5625 SK5626 SK5627 SK5628 SK5629 SK5631 SK5632 SK5633 SK5634 SK5635 SK5636 SK5637 SK5638 SK5639 SK5640 SK5642 SK5644 SK5645 SK5646 SK5647 SK5648 SK5649 SK5650 SK5653 SK5654 SK5655 SK5657 SK5659 SK5661 SK5662 SK5663 SK5664 SK5665 SK5666 SK5667 SK5668 SK5669 SK5670 SK5671 SK5672 SK5673 SK5674 SK5675 SK5676 SK5677 SK5678 SK5679 SK5680 SK5681 SK5682 SK5683 SK5684 SK5685 SK5687 SK5688 SK5689 SK5692 SK5693 SK5695 SK5696 SK5697 SK5698 SK5700 SK5702 SK5703 SK5704 SK5705 SK5706 SK5707 SK5708 SK5709 SK5710 SK5711 SK5713 SK5714 SK5715 SK5718 SK5719 SK5720 SK5723 SK5727 SK5729 SK5730 SK5731 SK5732 SK5733 SK5734 SK5735 SK5736 SK5737 SK5738 SK5739 SK5740 SK5741 SK5742 SK5743 SK5744 SK5745 SK5746 SK5747 SK5748 SK5749 SK5750 SK5751 SK5752 SK5753 SK5754 SK5756 SK5757 SK5758 SK5759 SK5760 SK5761 SK5762 SK5763 SK5764 SK5765 SK5766 SK5767 SK5768 SK5770 SK5771 SK5772 SK5773 SK5774 SK5775 SK5776 SK5777 SK5778 SK5779 SK5780 SK5781 SK5782 SK5784 SK5785 SK5787 SK5788 SK5789 SK5790 SK5791 SK5792 SK5793 SK5794 SK5795 SK5796 SK5797 SK5798 SK5799 SK5800 SK5802 SK5803 SK5804 SK5805 SK5806 SK5807 SK5808 SK5809 SK5810 SK5811 SK5813 SK5814 SK5815 SK5816 SK5817 SK5818 SK5819 SK5820 SK5822 SK5823 SK5824 SK5825 SK5826 SK5827 SK5829 SK5830 SK5831 SK5832 SK5833 SK5834 SK5835 SK5837 SK5839 SK5840 SK5841 SK5842 SK5843 SK5845 SK5846 SK5848 SK5849 SK5850 SK5851 SK5853 SK5854 SK5856 SK5857 SK5860 SK5861 SK5862 SK5863 SK5864 SK5865 SK5866 SK5867 SK5868 SK5869 SK5871 SK5873 SK5874 SK5876 SK5878 SK5879 SK5880 SK5881 SK5882 SK5883 SK5884 SK5885 SK5887 SK5888 SK5890 SK5892 SK5893 SK5894 SK5895 SK5896 SK5897 SK5898 SK5899 SK5900 SK5901 SK5902 SK5904 SK5906 SK5907 SK5908 SK5909 SK5910 SK5911 SK5912 SK5913 SK5916 SK5918 SK5919 SK5920 SK5922 SK5923 SK5924 SK5925 SK5926 SK5930 SK5931 SK5932 SK5933 SK5934 SK5935 SK5939 SK5942 SK5943 SK5945 SK5946 SK5947 SK5950 SK5951 SK5954 SK5955 SK5959 SK5960 SK5961 SK5962 SK5963 SK5964 SK5965 SK5967 SK5969 SK5970 SK5973 SK5975 SK5976 SK5977 SK5978 SK5979 SK5980 SK5982 SK5983 SK5984 SK5986 SK5988 SK5989 SK5991 SK5992 SK5993 SK5994 SK5995 SK5996 SK5999 SK6000 SK6001 SK6002 SK6004 SK6008 SK6009 SK6010 SK6012 SK6015 SK6016 SK6018 SK6057 SK6099 SK6111 SK6139 SK6243 SL0015 SL0086 SL0105 SL0114 SL0116 SL0160 SL0205 SL0354 SL0530 SL0792 SL0905 SL0912 SL0917 SL0940 SL0974 SL0980 SL0982 SL0984 SL0985 SL0993 SL0996 SL1006 SL1007 SL1010 SL1012 SL1013 SL1014 SL1016 SL1017 SL1019 SL1020 SL1021 SL1022 SL1023 SL1024 SL1027 SL1028 SL1029 SL1030 SL1031 SL1032 SL1033 SL1035 SL1037 SL1040 SL1042 SL1043 SL1044 SL1047 SL1054 SL1055 SL1062
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
For Additional Information Contact Alex Mathews
408-523-2100
Manufacturer 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.
FDA Determined
Cause 2		 Equipment maintenance
Action On 02/10-13/2023, Intuitive Surgical sent "Urgent Medical Device Correction" letters via email to inform two Groups of Customer (Group 1 and Group 2) that, a population of da Vinci Z and Xi Systems instrument arms (USMs-Universal Surgical Manipulators) have instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor which prevents free-fall motion or complete detachment from the USM. However, the Instrument Carriage may feel like it is not tightly connected to the rail. This condition may also lead to increased friction along the insertion axis. Instructions for Customers in Group 1 (reference Appendix A of their Letter): Stop/Cease use of the affected systems until Intuitive Representatives can replace the affected USMs on their systems. Instructions for Customers in Group 2 (reference Appendix B of their Letter): Can continue to use affected systems, but prior to each use, need to perform inspection of all the instrument carriages using the "Instrument Carriage Inspection Instructions" (refer letter for details of inspection). For questions or additional guidance: -US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. -Europe, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com -South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com -Japan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com -Taiwan: 886-2-2-27008181 (9 AM to 6:00 PM CST) or CS.taiwan@intusurg.com -India: 1800 103 6952 (9:00 AM to 6:00 PM IST) or Email address: support.india@intusurg.com
Quantity in Commerce 1,225 total USMs
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, Hong Kong, Hungary, Iceland, Indonesia, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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