# FDA recall Z-0283-2021

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2019-06-17.

## Product

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.

## 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.

## Distribution

US Nationwide distribution including in the state of Washington.

## Key facts

- **Recall number:** Z-0283-2021
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-17
- **Report date:** 2020-11-04
- **Termination date:** 2022-07-18

- **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-0283-2021

## Citation

> AI Analytics. FDA recall Z-0283-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-0283-2021. Source: US FDA. Licensed CC0.

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