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Intuitive Surgical, Inc. recalls User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manua
Recalled June 5, 2013 · FDA recall Z-1424-2013 · Intuitive Surgical
Hazard
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use. · FDA Class II
Units
1,374
Sold at
US Distribution Only
Description
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Product
User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for Transoral Surgery (TORS) provided information to update and replace the Indications for Use and Representative uses section and add the section Warnings for Transoral Otolaryngology Surgery.
Manufacturer(s)
Intuitive Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →