# FDA recall Z-2260-2020

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2019-04-01.

## Product

da Vinci SP surgical system

## Reason for recall

Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly.  This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force against the hand control haptic feedback.

## Distribution

U.S.: OH, PN, NY, MN, TN, TX, OR, IL, MD, NJ, AL.  O.U.S.: South Korea

## Key facts

- **Recall number:** Z-2260-2020
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-01
- **Report date:** 2020-06-10
- **Termination date:** 2021-12-16

- **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-2260-2020

## Citation

> AI Analytics. FDA recall Z-2260-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2260-2020. Source: US FDA. Licensed CC0.

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