FDA-Device2015-07-08Class II
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Intuitive Surgical, Inc.
Hazard
Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Affected count
310
Manufactured in
1266 Kifer Rd Bldg 100, Sunnyvale, CA, United States
Products
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1949-2015Don't want to check this manually?
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