FDA-Device2014-07-09Class II
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
Intuitive Surgical, Inc.
Hazard
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.
Affected count
All distributed prior to June 2014
Manufactured in
1266 Kifer Rd Bldg 100, Sunnyvale, CA, United States
Products
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1972-2014Don't want to check this manually?
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