Class 2 Device Recall da Vinci S Surgical System IS2000

• Date Initiated by Firm: June 01, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated 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: 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; 510(K)s with Product Code = NAY