# FDA recall Z-3254-2018

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2018-07-16.

## Product

da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units     The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.

## Reason for recall

Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, Norway, New Zealand, Romania, Russia, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, and Venezuela.

## Key facts

- **Recall number:** Z-3254-2018
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-16
- **Report date:** 2018-10-03
- **Termination date:** 2023-10-05

- **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-3254-2018

## Citation

> AI Analytics. FDA recall Z-3254-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3254-2018. Source: US FDA. Licensed CC0.

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