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U.S. Department of Health and Human Services

Class 2 Device Recall IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System

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  Class 2 Device Recall IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System see related information
Date Initiated by Firm March 15, 2013
Date Posted April 13, 2013
Recall Status1 Terminated 3 on September 04, 2014
Recall Number Z-1109-2013
Recall Event ID 64755
510(K)Number K050369  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000.

Arm drapes protect equipment from contamination.
Code Information Model number 550516-05
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
Manufacturer Reason
for Recall
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Intuitive Surgical sent an "Urgent Medical Device Correction" letter dated April 1, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 800-876-1310 for questions regarding this letter.
Quantity in Commerce 1642 customers
Distribution Worldwide Distribution.-USA (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
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.