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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S. Surgical System, da Vinci Si and da Vinci Sie Surgical Systems

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 Class 2 Recall
da Vinci S. Surgical System, da Vinci Si and da Vinci Sie Surgical Systems
see related information
Date Posted March 13, 2012
Recall Status1 Terminated on May 09, 2012
Recall Number Z-1202-2012
Recall Event ID 61156
Premarket Notification
510(K) Numbers
K063220  K081137 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product 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.
Code Information 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 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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
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
For Additional Information Contact Richard Reeves
408-523-2144
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 1966 systems are in commerce at hospital locations.
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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