Device product
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.
Z-1689-2013
Product summary
- Event
- Event 65590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 total, all devices
- Official record key
device-enforcement:Z-1689-2013
Official wording
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 information: Part number 372012-96: Serial numbers: 323986 324198.
Distribution pattern: Worldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
Derived failure modes
-
Unknown
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.