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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S Surgical System IS2000

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  Class 2 Device Recall da Vinci S Surgical System IS2000 see related information
Date Initiated by Firm June 01, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on July 29, 2009
Recall Number Z-2204-2008
Recall Event ID 48680
510(K)Number K050369  K060322  
Product Classification Computer Controlled Surgical System - Product Code NAY
Product da Vinci S Surgical System, Model number IS2000 Endoscopic Instrument Control System, manufactured by Intuitive Surgical, Sunnyvale, CA.
Code Information Serial numbers SG099, SG145, SG162, SG205, SG294, SG295, SG298, SG299, SG300, SG301, SG302, SG303, SG304, SG305, SG306, SG307, SG308, SG309, SG310, SG311, SG312, SG313, SG314, SG315, SG316, SG317, SG318, SG319, SG320, SG321, SG322, SG323, SG324, SG325, SG326, SG327, SG328, SG329, SG330, SG331, SG332, SG333, SG334, SG35, SG336, SG337, SG39, SG340, SG341, SG342, SG323, SG344, SG345, SG346, SG347, SG348, SG349, SG350, SG351, SG352, SG353, SG355, SG356, SG357, SG358, SG359, SG360, SG361, SG362, SG363, SG364, SG365, SG367, SG368, SG369, SG370, SG371, SG373, SG374, SG375, SG376, SG379, SG380, SG381, SG382, SG383, SG384, SG385, SG386, SG387, SG388, SG390, SG393, SG394, SG395, SG396, SG397, SG399, SG400, SG401, SG402, SG403, SG404, SG405, SG406, SG407, SG408, SG409, SG410, SG411, SG412, and SG413
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		 Defective software chip may cause the system to fail and lock up.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action Recall initiated June 1, 2008. Urgent Device Recall Letters were sent via e-mail, with follow up phone calls and service visits to correct the product. The firm recommended that continued use of the da Vinci S Surgical System during the time period prior to our service update to replace the software chip. The letter emphasizes the importance of always having backup equipment and instrumentation available when performing surgery with the da Vinci S Surgical System and being prepared to convert to alternative surgical techniques, if necessary. Customers are asked to fill out and return the acknowledgement form.
Quantity in Commerce 112 systems
Distribution Worldwide Distribution --- including USA and countries of Belgium, Bulgaria, Canada, China, Denmark, France, Germany, Italy, Korea, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, and United Kingdom.
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 = CLINIQA CORPORATION
510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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