medical Class II Updated 2020-02-05

Intuitive Surgical, Inc. recalls The da Vinci SP surgical system is made of three main compon

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Distribution: Product distributed in the US to the following states: Minnesota, New York, Ohio, and Pennsylvania.
Lot/Code Info: The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.
View official government recall

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