User Manual addendum, TORS for da Vinci Surgical System IS 1200, IS 2000 and IS 3000. Product Usage: The user manual for
FDA device recall Z-1424-2013 · posted 2013-05-29 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Change to User Manual to remove one indication for use and amend warnings to emphasize restrictions for use.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1,374
- Distribution
- US Distribution Only
- Date initiated
- 2013-01-24
- Date posted
- 2013-05-29
- Date terminated
- 2013-05-30
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 (K090993) | Intuitive Surgical, Inc. | 2009-12-16 |