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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 Recall
da Vinci S Surgical System
see related information
Date Posted June 12, 2008
Recall Status1 Terminated on August 15, 2008
Recall Number Z-1180-2008
Recall Event ID 46716
Premarket Notification
510(K) Number
K050369 
Product Classification System,Surgical,Computer Controlled Instrument - 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, California 94086-5206
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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