# FDA recall Z-2630-2017

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2017-06-01.

## Product

da Vinci Xi Surgical System    Product Usage:  The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures in the pelvic, abdominal, and thoracic cavities.

## Reason for recall

da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.

## Distribution

Worldwide Distribution - US Nationwide in the states of TX, NY,FL, IL, OH, and countries of France, Ireland, Japan, and Taiwan

## Key facts

- **Recall number:** Z-2630-2017
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-01
- **Report date:** 2017-07-05
- **Termination date:** 2017-10-02

- **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-2630-2017

## Citation

> AI Analytics. FDA recall Z-2630-2017. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2630-2017. Source: US FDA. Licensed CC0.

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