FDA Device recall Z-1689-2013
da Vinci Instrument Control Box, model number ICB3000
- FDA Device
- Class II
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class II recall of da Vinci Instrument Control Box, model number ICB3000 by Intuitive Surgical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1689-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-08 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | AZ, CA, CO, FL, HI, MT, NY, TX, UT, WA |
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.
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.
Identifiers
| code_info | Part number 372012-96: Serial numbers: 323986 324198. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1689-2013%22
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