Recall Z-1688-2013 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
| Date | Jul 11, 2013 (initiated Jun 8, 2013) |
| Status | Terminated |
| Reason | Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly. |
| Root cause | Software design |
| Action | Intuitive Surgical sent an Urgent Device Correction notice dated July 15, 2013, to all affected customers by Federal Express.The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that all affected personnel were fully informed of the notification and that the notification should be forwarded to other managers within their facility. Customers were also instructed to complete and return the attached Acknowledgment Form to acknowledge receipt of the notification. Customers with questions were instructed to call Custome |
| Quantity | 30 total, all devices |
| Distribution | Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101077 | DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 Intuitive Surgical, Inc., Feb 4, 2011 |