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Intuitive Surgical, Inc. recalls da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewe
Recalled November 6, 2013 · FDA recall Z-0088-2014 · Intuitive Surgical
Hazard
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount. · FDA Class II
Units
1,090 consoles
Sold at
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
Description
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
Product
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →