| Class 2 Device Recall da Vinci S Surgical System |  |
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
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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 |
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 |
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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
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