# FDA recall Z-1293-2023

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2023-02-10.

## Product

da Vinci Xi Surgical System Model IS4000    da Vinci X Surgical System Model IS4200

## Reason for recall

Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail component not being manufactured within specifications.

## Distribution

U.S.: Cayman Islands, Dominican Republic, Puerto Rico, United States  O.U.S.: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Luxembourg, Martinique, Monaco, Netherlands, Norway, Reunion, Sweden, Switzerland, United Kingdom, India, Japan, South Korea, Taiwan, Brazil, Argentina, Australia, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, Indonesia, Israel, Italy, Kuwait, Lebanon, Malaysia, Malta, Mexico, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Thailand, Turkey, United Arab Emirates, Uruguay, Venezuela, Vietnam

## Key facts

- **Recall number:** Z-1293-2023
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-10
- **Report date:** 2023-04-05

- **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-1293-2023

## Citation

> AI Analytics. FDA recall Z-1293-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1293-2023. Source: US FDA. Licensed CC0.

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