Recall
Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
Intuitive Surgical, Inc. · 6 Oct 2023
- Status
- Recall open, classified
- Why, in the FDA's words
- “There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.”
- Recall began
- 6 Oct 2023
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K152448
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.