Recall
da Vinci S Surgical System IS2000 Endoscopic Instrument Control System, rev. A51_P7, manufactured by Intuitive Surgical, Sunnyvale, CA.
Intuitive Surgical, Inc. · 15 July 2009
- Status
- Recall terminated
- Why, in the FDA's words
- “Gripper or Scissor jaws may close inadvertently, and will not open on command and various other reported modes of failure. Control by surgeon may fail and this failure may be difficult to detect.”
- Recall began
- 15 July 2009
- 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.