Recall
da Vinci S Surgical System, Model number IS2000 Revision number A51 P5; endoscopic surgical control system, Intuitive Surgical, Inc., Sunnyvale, CA 94086
Intuitive Surgical, Inc. · 27 Dec 2007
- Status
- Recall terminated
- Why, in the FDA's words
- “Delay in responding: In certain circumstances, the device may not respond immediately to a user's command such as master clutch or camera control.”
- Recall began
- 27 Dec 2007
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K050369
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.