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U.S. Department of Health and Human Services

Class 2 Device Recall daVinci

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 Class 2 Recall
daVinci
see related information
Date Posted May 29, 2013
Recall Status1 Terminated on May 30, 2013
Recall Number Z-1424-2013
Recall Event ID 65094
Premarket Notification
510(K) Number
K090993 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Code Information Model number 552002-01
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
For Additional Information Contact Richard Reeves
408-523-2244
Manufacturer Reason
for Recall
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Intuitive sent an Important Medical Device Correction letters dated January 24, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate and discard the existing TORS addendum, place the new TORS addendum included with this letter with your System User Manual, and complete and return the attached Acknowledgement Form to Intuitive Surgical. For questions call Intuitive Surgical Customer Service at 1-800-876-1310.
Quantity in Commerce 1,374
Distribution Worldwide distribution- USA Nationwide-list of countries not available.
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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