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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci Si Surgical System IS3000

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  Class 2 Device Recall da Vinci Si Surgical System IS3000 see related information
Date Initiated by Firm October 17, 2011
Date Posted October 28, 2013
Recall Status1 Terminated 3 on October 28, 2013
Recall Number Z-0088-2014
Recall Event ID 66434
510(K)Number K081137  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer.

Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Code Information model numbers 380610-04 through 38-610-14.
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
408-523-2100
Manufacturer Reason
for Recall		 Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
FDA Determined
Cause 2		 Use error
Action Advisory letters were sent to all affected customers on 10/17/11 informing them to contact Customer Service prior to moving the system outside of the hospital.
Quantity in Commerce 1,090 consoles
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, 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.
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