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Class 2 Device Recall da Vinci S Surgical System |
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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
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Product Classification |
endoscopic surgical control system - Product Code NAY
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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
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For Additional Information Contact |
408-523-2100
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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