Recall
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure…
Intuitive Surgical, Inc. · 13 Oct 2011
- Status
- Recall terminated
- Why, in the FDA's words
- “Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).”
- Recall began
- 13 Oct 2011
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K090993
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.