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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Si Surgeon Console

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 Class 2 Recall
da Vinci Si Surgeon Console
see related information
Date Posted May 29, 2013
Recall Status1 Terminated on May 30, 2013
Recall Number Z-1429-2013
Recall Event ID 65083
Premarket Notification
510(K) Number
K050369 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Code Information Model number: 314850, versions 1-6
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
Clarification of existing labeling information and operating procedures.
FDA Determined
Cause 2
MISBRANDING: Labeling False and Misleading
Action Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.
Quantity in Commerce NA
Distribution Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.
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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