Recall Z-1424-2013— Intuitive Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2013-01-24, terminated 2013-05-30. It names one FDA 510(k) clearance: K090993. 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.. Reason: Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-24
- Terminated
- 2013-05-30
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
1 on FDA's record- K090993 — INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.