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Intuitive Surgical, Inc. recalls da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intui
Recalled July 17, 2013 · FDA recall Z-1686-2013 · Intuitive Surgical
Hazard
Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. · FDA Class II
Units
30 total, all devices
Sold at
Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
Description
Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Product
da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →