Recall Z-0088-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.
| Date | Oct 28, 2013 (initiated Oct 17, 2011) |
| Status | Terminated |
| Reason | Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount. |
| Root cause | Use error |
| Action | Advisory letters were sent to all affected customers on 10/17/11 informing them to contact Customer Service prior to moving the system outside of the hospital. |
| Quantity | 1,090 consoles |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081137 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 Intuitive Surgical, Inc., Feb 18, 2009 |