Recall
The da Vinci SP surgical system 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 component of the SP system and its primary function is to…
Intuitive Surgical, Inc. · 23 Oct 2018
- Status
- Recall terminated
- Why, in the FDA's words
- “The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.”
- Recall began
- 23 Oct 2018
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K173906
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.