Recall
da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative…
Intuitive Surgical Inc · 11 April 2019
- Status
- Recall terminated
- Why, in the FDA's words
- “Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.”
- Recall began
- 11 April 2019
- Company
- Intuitive Surgical Inc
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K131861
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.