Recall of Device Recall da Vinci S. Surgical System, da Vinci Si and da Vinci Sie Surgical Systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61156
  • Event Risk Class
    Class 2
  • Event Number
    Z-1202-2012
  • Event Initiated Date
    2012-02-06
  • Event Date Posted
    2012-03-13
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, surgical, computer controlled instrument - Product Code NAY
  • Reason
    The holding brake, a component of the da vinci s surgical system, may allow passive uncontrolled motion due to gravity during specific power-off conditions.
  • Action
    Intuitive Surgical sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated February 3, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provided new instructions for use. Additionally, a Device Correction Response Form was enclosed for customers to complete and return via fax to 408-523-1390. Contact Intuitive Surgical Customer Service at 1-800-876-1310 for questions regarding this notice.

Device

  • Model / Serial
    IS2000 and IS3000, serial numbers: USG484 USG364 SH1071 SH0569 SH0508 SH0449 SH0412 SH0063 SG489 SG204 SG2013 SG2006 SG804 SG108 SG150 SG734 SH0411 SH0209 SH0329 SH0148 SG326 SG794 SH0511 SH1102 SH0991 SH0882 SH0881 SH0878 SH0758 SH0757 SH0573 SH0570 SH0568 SH0567 SG675 SG176 SH0210 SH0364 USG071 SG498 SG095 SG070 SG735 SG076 SG779 SH0817 SH0461 SG597 SG306 SH0636 SH0190 SG411 SH0475 SH0915 SH0234 USG043 SG2024 SH0564 USG754 SH0841 SG572 SG830 SG812 SG369 SG2018 SG834 SH0653 SH0086 SH0957 SH0659 SH0406 SH0249 SG031 SH0258 SG035 SG608 SH0293 SH0280 SH0334 SG447 SH0430 SH1129 SG448 SH0275 SG280 SH0681 SG302 SG327 SG325 SG086 SG291 SG614 SG129 SG626 SG417 SG104 SH0229 SG106 SH0227 SG105 SH0228 SH1029 SG655 SG653 SH0772 SH0092 SH0750 SG088 SH0594 SH0154 SG235 USG508 SG785 SH0501 SH0079 SH0202 SH0730 SH0977 SH0110 SH0651 SH0942 SH0933 USG026 SH0932 SG188 USG132 SG534 SG595 SG276 SH0180 SG193 SG842 SH1123 SH1003 SG412 SG180 SH0478 SH0513 SH0862 SG318 SH0109 SH0642 SG565 SG197 SH0640 SH0399 SG611 SH0872 SH0175 SG2001 SG211 SH0315 SH0678 SH0993 SG184 SH1086 SG143 USG515 SG662 SH0619 SH0696 SH0768 SH0767 SH1145 SH0247 SH0711 SH0779 SH0536 SH0361 SG883 SG820 SG816 SG757 SG738 SG665 SG467 SG435 SG349 SG290 SG2008 SG159 SG667 SH0285 SG284 SH0663 SG362 SG825 SG776 SG714 SG827 SG875 SG838 SG258 SG740 SH0271 SG308 SG839 SG383 SG465 SH0093 SG259 SG257 SG537 SH1093 SH0423 SH0491 SG781 SH0121 SH0751 SG100 SG588 SG768 SH1124 SG533 SG548 SH0997 SH0897 SG2033 SG706 SG466 SG2041 SG138 SG419 SH0410 SH0884 SG382 SH0811 SG739 SH0497 SH0858 SG674 SH0701 SH0986 SG055 SH0967 SH0670 SH0669 SH0355 SH0610 SG564 SG387 SG632 SH0431 SH1081 SH0493 SH0473 SH0755 SH0729 SH0673 SH0722 SH1018 SH1091 SH0419 SG612 SH1026 SG422 SH0450 SH0089 SG200 SH1068 SH0592 SH0591 SH0141 SH0794 SG2028 SG107 SH0087 SH1103 SG160 SH0213 SG553 SH0452 SH0928 SG222 SH0705 SG621 SH0896 SH0042 SH1143 SG561 SG697 SH0173 SH0291 SG540 SG758 SH0987 SH0072 SH0693 SG766 SG026 SG075 SG682 SG831 SG130 SG809 SG813 SG805 SG671 SH0820 SG335 SG005 SG808 SG252 SG829 SH0965 SG815 SG814 SH0067 SG578 SG423 SH0892 SH0886 SG322 SG303 SG399 SH1097 SH1004 SG087 SG2020 SH1005 SH0522 SG357 SG374 SH0193 SH0372 SG677 SG398 SG716 SG260 SH1036 SH0127 SH0019 SG328 SG320 SG207 SG233 SG232 SH0778 SH0200 SH0199 SH0198 SH0197 SH0196 SG275 SG2022 SG008 SG438 SG368 SG733 SG678 SG708 SH0832 SG795 SH1114 SH0833 SH0680 SG640 SG679 SG347 SG370 SH0296 SG596 SH1070 SH0454 SH1106 SH0801 SH0800 SH0799 SH0297 SH0272 SH0810 SH0345 SG645 SH0585 SG503 SH0308 SG077 SG619 SG270 SG265 SH0177 SH0054 SH0733 SH0665 SH0658 SH0574 SH0534 SH0357 SH0328 SH0251 SH0062 SG823 SG742 SG452 SG425 SH0893 SH0598 SH1069 SG725 SH1017 SG520 SH0332 USG113 SG566 SG835 SH0714 SG762 USG703 SG551 SG2009 SG2015 SG189 SH0962 SG605 SH0474 SG582 SG481 SH0980 SH0088 SH0528 SH0743 SH1031 SH0443 SG2037 SH0654 SG2035 SG2004 USG642 USG332 SH0698 SH0689 SH0690 SH0688 SG661 SG2030 SH0910 SH0909 SG116 SH0218 SG166 SH0921 SH0798 SG255 SG436 SH0555 SH0116 SH0816 SG495 SG652 SH0126 SG434 SG472 SG122 SH0609 SH1013 SG2029 SH0737 SG194 SH0641 SG643 SH0964 SH0309 SH1076 SG636 SH0113 USG213 SH0115 SH0356 SG514 SH1059 SH0704 SH0727 SH0898 SG429 SH0025 SH0048 SG752 SH0869 SG033 SH0927 SH0181 SH1134 SH0349 SG575 SG301 SG523 SG524 SH0516 SG641 SH0256 SG299 SG437 SH0668 USG230 SH1052 SH0279 SH0278 SH0052 SH0051 SG373 SG371 SG2034 SG048 SH0624 SH0499 SH0498 SH0049 SG054 SH0956 SH1149 USG728 SG771 SH0333 SG027 SH0440 SH0165 SH0702 SG500 SH0904 SH0903 SG307 SG078 SG269 SG2025 SH0890 SG492 SH0835 SG672 SG724 SH1148 SH1136 SG623 SH0853 SH0793 SH0224 USG146 SH1132 SH0638 SH0515 SH0417 SH0354 SH0036 SG144 SG660 SH1138 SG822 SH1014 SH0082 SH0547 SG283 SG507 SH0529 SH0445 SH0490 SG112 SH0813 SH0167 SH0565 SG406 SH0740 SG841 SG505 SG689 SG819 SG530 SG664 SG378 SG377 SG366 USG317 SH0103 SH0099 SG177 SH0985 SH0058 SH0885 SG765 SH0868 SH0353 SG456 SG457 SH0390 SG573 SH0527 SH0526 SH0018 SG658 SG162 SG149 SG051 SH0712 SH0432 SH0946 SH0906 SH0721 SG2031 USG727 SH0759 SH0339 SG562 SH0531 SG351 SG169 SG555 SG554 SH1001 SH0463 SH0608 SG584 SG400 SG123 SH0174 SH0976 SG461 SH0796 SH0633 SH1092 SG699 SG271 SG272 SH0560 SH0781 SH0780 SH0521 SG618 SG237 SH0622 SG427 USG201 USG044 SH0035 SH0703 SH0055 SG254 SH0192 SH0556 SH0971 SH0301 SG432 SG073 SH0647 SH0489 SH1041 SH0859 SH0404 SH1057 SG288 SH0352 SH0468 SG755 SG476 SG471 SG300 SG571 SG350 SH1061 SH1108 USG806 SH1073 SH1028 SG199 SH1064 SH1088 SG844 SG828 SH0589 SH1153 SH1083 SH0546 SG267 SH1042 USG800 SH1012 SH1011 USG802 SH0477 SH0045 SH0671 SH0426 SG167 SG360 SH0613 SH0694 SG760 SG2027 SG798 SG710 SH0988 SG544 SG021 SH0948 SG628 SH0723 SH0683 SH0697 SH1023 SH0214 SG485 SG131 SH0551 SH0169 SH0168 SH0171 SG091 USG775 SH0789 SH0170 SG263 SH0085 SH0273 SH0205 SH0398 SG292 SG246 SH0504 SH0123 SG528 SH1090 SH0639 SG480 SH0880 SH1062 SH1113 SG430 SH0350 SH0939 SH0012 SG372 SH0186 SH0655 SH0013 SH0827 SG521 SG068 SH0699 SH0995 SG179 SH1019 SG736 SG482 SH0505 SG415 SH0156 SG450 SG901 SG897 SG878 SG895 SG884 SG888 SG2023 SG899 SG862 SG886 SG896 SG863 SG900 SG850 SG893 SG892 SG874 SG887 SG894 SG877 SG885 SG889 SG898 SG052 SH0805 SH0584 USG748 USG750 SG224 SG223 SH0646 SH0429 SH0139 SH0138 SG003 SG891 SG861 SG860 SG859 SG858 SG857 SG856 SG855 SG854 SG853 SG852 SG851 SG849 SG848 SG558 SG547 SH0996 SH0754 SH0464 SH0307 SG531 SH1152 SH0060 SG281 SH0761 SG676 SH0317 USG726 SH0488 SH0403 SG761 SG591 SH0201 SG024 SG579 SH1079 SG196 SH1047 SH0593 SH0562 SG379 SG081 SG711 SH0028 SG346 SG2039 USG577 SG483 SH0958 SH0561 SH0084 SG753 SG478 SH0828 SH0377 SG666 SG833 SH0870 SG315 SG047 SG2005 SH0422 SH0421 SG173 SG2032 SG638 SH0629 SH0628 SH0774 SG253 SH1051 SH1050 SG426 SG407 SH1060 SH0919 SH0476 SH0096 SH0300 SH0232 SH1115 SH0715 USG788 SH0582 SG464 SH0250 SH0935 SH0864 SH1080 SG083 SH0625 SG746 SH0687 SG096 SH0648 SG312 SH0483 SH1085 SH0618 SG440 SH0905 SH0203 SG049 SH0825 SH0766 SH0819 SG602 USG700 USG631 SH0940 SH0923 SG745 USG147 SG585 SH0635 SH0056 SH0466 SG723 SG140 SG620 SG363 SH0902 SG339 SH0111 SH0691 SG183 SH0360 SG355 SG593 SG185 SG418 SH0220 SG793 SH0216 SH0215 SH0925 SH0912 SH0559 SH0558 SH0575 SH0206 SH0615 SH0614 SH0185 SH0572 USG552 SH0731 SH0535 SG792 SG698 SH0760 SG509 SG310 SG174 SH0874 SG297 SH0321 SH1002 SH0792 SG409 SH0550 SH0397 SH0456 SG198 SH0839 SH0821 SH0782 SH0749 SH0748 SH0129 SG215 SG161 USG770 SH0804 SH0786 SH0685 SH0557 SH0441 SH0344 SH0343 SH0342 SH0207 SG234 SH0934 SH0040 SH1055 SH1054 SH0577 SH0576 SH0152 271326 SH1022 SH0163 SH0374 SH0033 SG783 SH0979 SG333 SG2011 SH0020 SH0963 SH0532 SH1130 SH1032 SH0847 SH0806 SH0732 SG778 SG763 SG615 SG490 SG441 SG244 SG433 SH0617 SG470 SG644 SH0437 USG559 SH0777 SH0385 SH0306 SH0069 SG569 SG293 USG015 SH1151 SG444 SG039 SH0599 SH0140 SH0137 SG341 SG2026 SH0135 SG737 SG148 SH0348 SH1077 SH0643 SH1128 SG413 SH0068 SH0601 SH0204 SG696 SG609 SH0848 SH0717 SH0634 SH0183 SH0189 SH0265 SG486 SG345 253342 SH1104 SH1095 SH0645 SH0370 SH0260 SG570 SG431 SG359 SG268 SG242 SG120 SH0838 USG101 SH0184 SG463 SH1094 SG580 SH0597 SG603 SG182 SH0973 SH0972 SH0974 SH0900 SG060 SH0241 SH0580 SH0029 SH0151 SH0030 USG018 SG380 SH0552 SH0982 SG556 SH1087 SG145 SG549 SG439 SH0837 SH0230 SG497 SH0544 SH0953 SH0325 SH0057 SG473 SH0840 SH0376 SG458 SG334 SH0713 SH0153 SG890 SH0907 SH0736 SG659 SH1139 SG568 SG499 SH1040 SH0644 SH0401 SH0021 SG693 SG396 SH0242 SH0448 SH0286 SG020 SH0563 SG468 SH1027 SH0319 SG451 SG586 SH0438 SH0100 SH0954 SH0073 SH0590 SG2021 SG041 USG136 SG589 SH0632 SH0773 SH0649 SH0851 SG225 SH0253 SH0335 SH0842 SG607 SG195 SG474 SH0951 SH0950 SH0949 SH0166 SH0022 SG538 SG2017 SG191 SH0795 SH0586 SG319 SH0346 SH0439 SH0338 SH0337 SG128 SG289 SH0402 SH0041 SG542 USG642 USG577 USG515 USG136 SH1116 SH1100 SH1099 SH1055 SH1038 SH1001 SH0781 SH0578 SH0239 SG017 SH0814 USG773 USG125 SH1135 SH0428 SG139 SH0427 SH0975 SH0024 SH0108 SG790 SG557 SG036 USG701 SG261 SG2003 SH0442 SH0554 SH1133 SH0899 USG217 SH0631 SH0034 SG192 SH0695 SH0112 SH0026 SH0415 SH0414 SH0457 SH0549 SH0065 SH0420 SG262 SH0785 SH0947 SH0876 SH0510 SH0031 SG629 SG093 SH0368 SH0261 SH1067 SH0150 SH0455 SH0081 SG210 SG2045 SG502 SH0467 SG324 SH0434 SG526 SG212 SG080 SH0238 SG840 SG796 SG581 SG2012 SH0320 SG361 SG744 SG797 SG219 SH0545 SH0095 SG236 SH0465 SG245 SG475 SH0125 SG627 SH0887 SG598 SH0459 SH0413 SH0929 SH0495 SH0791 USG443 SG2040 SH0299 SG278 SH0118 SH0856 SG050 SG868 SH0931 SH0351 SH0124 SH0386 SH0834 SH0494 SH0188 SH1116 SH0187 SH0764 SH0765 SH0753 SG719 SH0131 SG117 SG606 SH0252 SG249 SG550 SH0845 SG408 SH0607 SH1075 SH0692 SG158 SH0990 SH1110 SH0707 SH1084 SH1056 SH0471 SG536 SH0223 USG062 SG401 SG098 SH1101 SH0961 SH0857 SH0742 SH0600 SH0147 SH0146 SH0145 SH0032 SH0268 SH0191 SH0875 SG410 USG053 SH1140 SH0861 SH0257 SG650 SG304 SG206 SH0157 SG683 SG202 SG019 SH0132 SG657 SH1038 SH1072 SH0143 SH1048 SG479 SG152 SH0871 SH0983 SH0739 SG695 SG205 SH0259 SG163 SH0908 SG2014 SH0803 USG721 SH1118 SG712 SG390 SH1066 USG764 SG305 SG803 SG264 SH0627 SG670 SG164 SH0844 SH0496 SH0756 SH0433 SG720 SG709 SH0815 SH1010 SH0506 SH0469 SH0581 SG391 SG691 SG385 SG119 SH0119 SG424 SH0596 SH0425 SH1096 SG477 SH0312 SG759 SG663 SH0679 SG807 SH0676 SH0675 SG178 SH0917 SH0451 SH0588 SH0134 SH0046 SG127 SG040 SG028 SG651 SH0380 SH0650 SH0807 SG510 SG337 SH0097 SG656 SH0133 SH0930 SH0891 SG442 SH0130 SG449 SG099 SH0270 SH0706 SG356 SG030 SG181 SH0866 SH0941 USG718 USG713 USG172 SH0822 SH0039 SH0818 SH0038 SH0852 SG493 SG491 SH0282 SH0064 SG647 SH0708 SH0823 SG625 USG151 SH0194 SH0709 SH0267 SG567 USG769 SH0266 SH0922 SH0149 SG780 SG344 SG336 SH0657 SG238 SH0217 SH0966 SH0383 SH0098 SG529 SH1074 SH0955 SH0393 SG488 SH0362 SH0323 SG216 SG038 SG014 SG157 SG843 SH0926 SH0162 SH0161 SG395 SG381 SH0620 SH0359 SG2038 SH0037 SG376 SH0700 SH0602 SH0503 SH0502 SH0078 SH0076 SH0274 SH0424 SH0936 SH0999 SH0179 SG624 SG496 SG494 SH1111 SG059 SH0776 SH1147 SG348 SH1037 SH1033 SH0240 SG022 SG563 SG799 SH0164 SH0867 SH0616 SH0486 SH0981 SH0292 SH0462 USG029 SH0746 SH0745 SG673 SG688 SH1137 SH0674 SH0409 SH0318 SH0883 SH0212 SH1034 SH0970 SG654 SG250 SG2007 SG2002 SG118 SH0378 SH1009 SH0994 SH0992 SH0863 SH0860 SH0595 SH0053 SG121 SH0288 SH1000 SH0514 SH1030 SH0485 SH0044 SH0518 SH0517 SG782 SH1144 SH1109 SH0763 SG637 SH1065 SH0989 SH0626 SH0612 SH0533 SH0519 SH0363 SG239 SG2010 SG065 SH0830 SH0829 SH0808 SG311 SH1058 SH0379 SH0246 SG574 SG2016 USG342 SH0938 SH0937 SH0790 SH0284 SH0136 SG546 SG404 SG342 SG175 SG013 SH0873 USG622 SH0104 SH0373 SH0290 SH0281 SH0254 SG403 SG397 SH0623 SH0102 SH0101 SG227 SG687 SG393 SH0716 SH0396 SG722 SG705 SG340 SH1127 SH1125 SG460 SG446 SG634 SH0479 SG576 SH0408 SH0233 SH0826 SG587 SG155 SH1053 SG613 SG386 SH1131 SH0762 SH0248 SH0231 USG082 SH1078 SH0400 SH0289 SG511 SG094 SG680 SH0984 SH0879 SG717 SH0741 SH0418 SG285 SG279 SH0901 SH1119 SH0662 SH0276 SG133 SG011 SH0211 SG543 SG535 SG601 SG247 SG142 SH0405 SH0395 SH0283 SG314 SG186 SG539 SG751 SH1043 SG648 SG832 SH1045 SG487 SG811 SH0061 SG743 SG669 SG729 SG298 SG741 SG583 SH0071 SH0195 SG756 SG273 SH1044 SH1105 SG633 SH0245 SG694 SH0725 SG103 SH0783 SG668 SH0330 SH0331 SH0324 SH0172 USG353 SH1008 SH1007 SH1006 SH0775 SH0460 SH0047 SG287 SG218 SH0682 SH0784 SG462 SH0263 SH0262 SG518 SH0849 USG331 SH0831 SG686 SH0630 SG063 SH0484 SG214 SG316 SH0543 SH0160 SG681 SH0298 SG309 SH0611 SH0487 SG367 SG058 SH0583 SH0340 SH0225 SH1039 SG321 SH0416 SG826 SH0894 SH0316 SG616 SH1089 SG707 SH0305 SH0843 SH1120 SH0530 SG012 SG504 SG731 SG324 SH0387 SG685 SH0066 SH0960 SH0391 SH1126 SH0235 SH0525 SH0482 SG208 SG821 SH0369 SG747 SH0458 SG170 SG165 SH0384 SG042 SG453 SH0208 SG241 SH1121 SH1063 SH0738 SH0367 SH0178 SH1035 SH0500 SG090 SH0277 SH1016 SH0945 SH0718 SG545 SH0389 SH0566 SG354 SH0719 SG251 SH0388 SH0809 SG067 SH0553 SH0998 SH0637 SH0155 SH0091 SH0077 SG522 SG454 SG009 SH0221 SH1015 SG594 SH0769 SH0094 SG527 USG517 USG156 USG072 SH1150 SH1142 SH1100 SH1099 SH1082 SH1025 SH0918 SH0914 SH0877 SH0855 SH0672 SH0621 SH0587 SH0571 SH0436 SH0435 SH0407 SH0382 SH0347 SH0311 SH0310 SH0304 SH0303 SH0302 SH0294 SH0255 SH0226 SH0182 SH0159 SH0158 SH0105 SH0080 SH0070 SH0059 SG420 SG329 SG296 SG295 SG294 SG231 SG2042 SG187 SG111 SG110 SG109 SG089 SC0005 SH1107 SG229 SH0735 SH0734 SG630 SH0523 SH0142 SH0392 SH0524 SH0394 SG153 SH0667 SH0090 SH0802 SG824 SG818 SH0117 SH0492 SG789 SH0520 SH0507 SH0381 SH0336 SG749 SG704 SG692 SG323 SG102 SG092 SH0371 SG599 SG532 SH0222 SG639 USG787 SH0606 SH0605 SH0604 SH0144 SG428 SG032 SH0295 SG358 SH1141 SG2019 SH0969 SH0968 SH0812 SG881 SG836 SH0447 SG046 SH0114 SH0664 SG837 SH1122 SH0579 SH1112 SH0375 SG286 SH0846 SH0924 SG455 SG516 SG037 USG786 SH0752 SH0107 SH0836 SG810 SG137 SH0050 SH0472 SG767 SG330 SH0219 SG034 SG784 USG240 SH0824 SH0677 SG061 USG352 SH0128 SG772 SH0512 SH0313 SH0314 SH0176 SH0686 SH1024 SH0889 SH0481 SH0480 SH0865 SH0684 USG702 SH0770 SH0920 SH0548 SG525 SG375 SG590 SG190 SG560 SG392 SG025 SG084 SG506 SG617 SH0747 SH0744 SH0358 SG732 SH1098 SH0656 SH0120 SG282 USG445 SH0453 SH0470 SH0854 SH0895 SH0106 SH0850 SG343 SH0243 SG313 SH0913 SH0726 SH0578 SG057 SH1146 SH0710 SH0509 SG168 SG684 SG801 SH0724 SH0327 SH0326 SG541 SG2036
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    da Vinci S. Surgical System, da Vinci Si and da Vinci Si-e Surgical Systems. || Intuitive Surgical, Inc. || Sunnyvale, CA 94086. || The Intuitive Surgical Endoscopic instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
  • Source
    USFDA