PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: July 17, 2013 Initiated: June 8, 2013 #Z-1688-2013

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.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
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.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Intuitive Surgical, Inc.. Units affected: 30 total, all devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 17, 2013. Severity: Moderate. Recall number: Z-1688-2013.