Z-0845-2020 Class II Terminated

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
February 5, 2020
Initiation Date
October 23, 2018
Termination Date
January 21, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 PSCs (Units)

Product Description

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.

Reason for Recall

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.

Distribution Pattern

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

Code Information

The Affected Systems are : SP0022, SP0023, SP0024, SP0025 and SP0026.