Recall Z-1424-2013 ยท NAY System, Surgical, Computer Controlled Instrument
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.
| Date | May 29, 2013 (initiated Jan 24, 2013) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090993 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 Intuitive Surgical, Inc., Dec 16, 2009 |