Recall
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci…
Intuitive Surgical, Inc. · 21 Oct 2013
- Status
- Recall terminated
- Why, in the FDA's words
- “Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.”
- Recall began
- 21 Oct 2013
- Company
- Intuitive Surgical, Inc.
- Device type
- Robot-assisted surgical systems (computer-controlled instruments) (NAY)
- Concerns
- K081137
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.