Intuitive Surgical, Inc. recalls The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and t…

Recall date

October 23, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0845-2020

FDA classification

Class II

Brand / firm

Intuitive Surgical, Inc.

Sold / distributed

Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 support the positioning of the surgical port (cannula) and to manipulate the surgical instruments and camera. The Model Number is SP 1098.