Recall Z-2734-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick
| Date | Sep 3, 2015 (initiated Aug 17, 2015) |
| Status | Terminated |
| Reason | Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software. |
| Root cause | Software design |
| Action | Intuitive sent an Urgent Medical Device Correction letters dated August 21, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Clinical Sales or ISI Customer service at 800-876-1310 Option 3. |
| Quantity | 198 affected devices |
| Distribution | Worldwide Distribution - US Nationwide and in the countries of Italy and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |