Recall
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Intuitive Surgical, Inc. · 10 Feb 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.”
- Recall began
- 10 Feb 2023
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
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.