Recall Z-0940-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endo
| Date | Jan 7, 2015 (initiated Dec 5, 2014) |
| Status | Terminated |
| Reason | Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening. |
| Root cause | Device Design |
| Action | The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated December 5, 2014 to all customers on December 5, 2014 by trackable method. The letter described the product, problem and actions to be taken. The customers were instructed to: ensure all affected personnel are fully informed of this notice; identify affected product, and retain a copy of this notice with your da Vinci Si user manual. Please note: the da Vinci Si Vision Side Cart can continue to be used safely. Ensure that all wheels are fully unlocked before attempting to move the Vision Side Cart. Avoid rol |
| Quantity | 202 |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom. |
| 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 |