Intuitive Surgical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0283-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.

Product Classification:

Class II

Date Initiated: June 17, 2019

Date Posted: November 4, 2020

Recall Number: Z-0283-2021

Event ID: 84963

Reason for Recall:

One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.

Status: Terminated

Product Quantity: 1 system

Code Information:

IS4000 Endoscope Controller, Serial Number: 432242 installed on the da Vinci Surgical System, Serial Number: SK2137

Distribution Pattern:

US Nationwide distribution including in the state of Washington.

Voluntary or Mandated:

Voluntary: Firm initiated