Recall
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
Intuitive Surgical, Inc. · 19 Sept 2011
- Status
- Recall terminated
- Why, in the FDA's words
- “Clarification of existing labeling information and operating procedures.”
- Recall began
- 19 Sept 2011
- 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.