# FDA recall Z-1262-2023

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2023-01-24.

## Product

Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200;    Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

## Reason for recall

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

## Distribution

Worldwide - US Nationwide distribution in the states of FL, GA, WA and the countries of  United Kingdom, Germany, France

## Key facts

- **Recall number:** Z-1262-2023
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-24
- **Report date:** 2023-03-22

- **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-1262-2023

## Citation

> AI Analytics. FDA recall Z-1262-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1262-2023. Source: US FDA. Licensed CC0.

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