FDA-Device2018-10-03Class II
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.
Intuitive Surgical, Inc.
Hazard
Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, Norway, New Zealand, Romania, Russia, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, and Venezuela.
Affected count
1,014 currently installed on systems
Manufactured in
1266 Kifer Rd Bldg 101, Sunnyvale, CA, United States
Products
da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3254-2018Don't want to check this manually?
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