Recall
IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination.
Intuitive Surgical, Inc. · 15 March 2013
- Status
- Recall terminated
- Why, in the FDA's words
- “Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.”
- Recall began
- 15 March 2013
- 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.