||July 11, 2013
||Terminated on January 22, 2014
|Recall Event ID
System,Surgical,Computer Controlled Instrument - Product Code NAY
||da Vinci Si Vision System Cart, model number VS3000;
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.
||Part number 380990-11:
|Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
|For Additional Information Contact
|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.
|DESIGN: Software Design
||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 Customer Service at 800-876-1310, Option 3.
For questions regarding this recall call 408-523-2244.
|Quantity in Commerce
||30 total, all devices
||Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.