Recall
Intuitive Surgical da Vinci Si Surgical System (IS3000); Mfg by: Intuitive Surgical, Sunnyvale, CA 94086 Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories.…
Intuitive Surgical, Inc. · 5 July 2011
- Status
- Recall terminated
- Why, in the FDA's words
- “Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.”
- Recall began
- 5 July 2011
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K090993
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.