Recall Z-2731-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: 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-ups, needle h
| Date | Sep 30, 2014 (initiated Sep 11, 2014) |
| Status | Terminated |
| Reason | Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a mid-procedure restart. |
| Root cause | Other |
| Action | Intuitive sent an Urgent Medical Device Correction letter dated September 11, 2014 to all consignees via trackable mail system. Letters identified the issue and provides information for users should a error code be displayed. For questions contact your Clinical Sales Representative or Intuitive Surgical Customer Service |
| Quantity | 75 devices |
| Distribution | Worldwide Distribution - US nationwide and the countries of: Belgium, Germany, China(Hong Kong), India, Israel, Italy, and the United Kingdom. |
| 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 |