Recall
da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086
Intuitive Surgical, Inc. · 9 March 2007
- Status
- Recall terminated
- Why, in the FDA's words
- “Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.”
- Recall began
- 9 March 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.