Recall Z-2341-2018 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) 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 holders, endoscopic retractors, electro
| Date | Mar 7, 2018 |
| Status | Terminated |
| Reason | Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards that were found to have a high rate of failure due to a defective component. |
| Root cause | Nonconforming Material/Component |
| Action | Intuitive Surgical, Inc. sent a Recall letters dated 3/7/2018 to affected customers via FedEx. The letter identified the affected product problem, risk to health, affected serial numbers, the action the firm will be taking, and the actions to be taken by the customer. |
| Quantity | 108 ACJ's on 35 surgical systems |
| Distribution | US Nationwide AR, CA, FL, GA, IL, IA, MN, MS, NE, OK, TN, and TX. Foreign distribution was made to Australia, Austria, Finland, France, Germany, Italy, Netherlands, Spain, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171294 | da Vinci X Surgical System Intuitive Surgical, Inc., May 26, 2017 |