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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S Surgical System

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  Class 2 Device Recall da Vinci S Surgical System see related information
Date Initiated by Firm December 27, 2007
Date Posted June 12, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = INTUITIVE SURGICAL, INC.
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