FDA Enforcement
Class II
Terminated
da Vinci Instrument Control Box, model number ICB3000; 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.
Recall: Z-1689-2013
·
Reported July 17, 2013
Enforcement
- Recall Number
- Z-1689-2013
- Event ID
- 65590
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Intuitive Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 17, 2013
- Initiation Date
- June 8, 2013
- Classification Date
- July 11, 2013
- Termination Date
- January 22, 2014
- Address
- 1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States
Description
da Vinci Instrument Control Box, model number ICB3000; 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.
Code Info
Part number 372012-96: Serial numbers: 323986 324198.
Distribution
Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
Quantity
30 total, all devices