Recall Z-1688-2013— Intuitive Surgical, Inc.

Name: FDA recall Z-1688-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-08

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2013-06-08, terminated 2014-01-22. It names one FDA 510(k) clearance: K101077. Product: 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.. 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..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-08
Terminated: 2014-01-22
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101077 — DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100Intuitive Surgical, Inc.·cleared 2011-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.