FDA-Device2016-03-30Class II
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
Intuitive Surgical, Inc.
Sold states
US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela.
Affected count
542 (351 SCC Touchpads and 191 PSC touchpads)
Manufactured in
1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, United States
Products
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1191-2016Don't want to check this manually?
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