Recall Z-1180-2008 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086
| Date | Jun 12, 2008 (initiated Dec 27, 2007) |
| Status | Terminated |
| Reason | Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control. |
| Root cause | Software design |
| Action | Beginning 12/28/2007, Intuitive Surgical Field Service Representatives visited each site to correct the issues. A notification letter was provided to all sites. |
| Quantity | 9 units |
| Distribution | USA Distribution: TX, NJ, WA, NV, HI, MI, NH and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc., Apr 29, 2005 |