Class 2 Device Recall Da Vinci S Surgical System

• Date Initiated by Firm: April 12, 2006
• Date Posted: March 29, 2007
• Recall Status: Terminated on December 05, 2007
• Recall Number: Z-0670-2007
• Recall Event ID: 37431
• 510(K)Number: K050369
• Product Classification: Endoscopic Instrument Control System - Product Code NAY
• Product: Intuitive brand Da Vinci S Surgical System, an Endoscopic Instrument Control System, Model SS2000 Patient Side Cart, Model PS2000, Part Number: 380267-01, IS2000, Top Level, 4-Arm; Distributed and Manufactured by: Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
• Code Information: System Numbers: SG011, SG012, SG013, SG014, SG017, SG018, SG019, SG020, SG058, and SG094.
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 950 Kifer Rd; Sunnyvale CA 94086-5206
• Manufacturer Reason for Recall: Da Vinci S Surgical System's spinal pin could limit mechanical motion of the arm and render the system unavailable for surgical use, and may result in system failure and the need to convert to an alternative surgical technique.
• FDA Determined Cause: Other
• Action: The firm did not release notification to its consignees. The reworks were arranged as part of routine service visits initiated on 4/12/06.
• Quantity in Commerce: 24 units
• Distribution: Nationwide.
• 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