Class II — Intuitive Surgical, Inc.
| Recalling firm | Intuitive Surgical, Inc. |
|---|---|
| Registered facility | View this company's 41 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening. |
| Product | IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue,… |
| Quantity | 202 |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom. |
| Initiated | 2014-12-05 |
| Classified | 2015-01-07 |
| Terminated | 2015-03-03 |
| Recall number | Z-0940-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intuitive Surgical, Inc. (Z-0940-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69902/
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