Class 2 Device Recall da Vinci S Surgical System

• Date Initiated by Firm: December 27, 2007
• Date Posted: June 12, 2008
• Recall Status: Terminated on August 15, 2008
• Recall Number: Z-1180-2008
• Recall Event ID: 46716
• 510(K)Number: K050369
• Product Classification: endoscopic surgical control system - Product Code NAY
• Product: da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086
• Code Information: Model number IS2000, Revision AP51 P5, System numbers SG015, SG020, SG040, SG103, SG152, SG169, SG179, SG213, SG215, SG355, top level part numbers 380267-01, 380431-02, and 380431-05
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 950 Kifer Rd; Sunnyvale CA 94086-5206
• For Additional Information Contact: 408-523-2100
• Manufacturer Reason for Recall: Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.
• FDA Determined Cause: Software design
• Action: Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites.
• Quantity in Commerce: 9 units
• Distribution: USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA
• 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