# FDA recall Z-1484-2022

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2022-06-22.

## Product

The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.

## Reason for recall

Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of  Belgium, Denmark, Germany, Japan, Italy, Monaco, Norway, Sweden, Switzerland, United Kingdom.

## Key facts

- **Recall number:** Z-1484-2022
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-22
- **Report date:** 2022-08-10

- **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-1484-2022

## Citation

> AI Analytics. FDA recall Z-1484-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1484-2022. Source: US FDA. Licensed CC0.

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