# FDA recall Z-2835-2018

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2018-05-17.

## Product

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

## 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.

## Distribution

U.S.

## Key facts

- **Recall number:** Z-2835-2018
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-17
- **Report date:** 2018-08-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2835-2018

## Citation

> AI Analytics. FDA recall Z-2835-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-2835-2018. Source: US FDA. Licensed CC0.

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