FDA Medical Device Recalls (openFDA)
Intuitive Surgical, Inc.: 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.
- Recall number
- Z-1424-2013
- Recalling firm
- Intuitive Surgical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-01-24
- Posted
- 2013-05-29
- Terminated
- 2013-05-30
- Reason
- Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
- Root cause
- Labeling False and Misleading
- Action
- Intuitive sent an Important Medical Device Correction letters dated January 24, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate and discard the existing TORS addendum, place the new TORS addendum included with this letter with your System User Manual, and complete and return the attached Acknowledgement Form to Intuitive Surgical. For questions call Intuitive Surgical Customer Service at 1-800-876-1310.
- Quantity
- 1,374
- Distribution
- US Distribution Only
- Lot, serial or model codes
- Model number 552002-01
- 510(k) numbers
- ["K090993"]
- PMA numbers
- not on file
- Product code
- NAY
- Firm FEI
- 3001675293
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28