Intuitive Surgical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2835-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.

Product Classification:

Class II

Date Initiated: May 17, 2018

Date Posted: August 22, 2018

Recall Number: Z-2835-2018

Event ID: 80691

Reason for Recall:

An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.

Status: Ongoing

Product Quantity: 1

Code Information:

UDI Number: 00886874114193. Serial Number: SK1703.

Distribution Pattern:

U.S.

Voluntary or Mandated:

Voluntary: Firm initiated