# FDA recall Z-0210-2018

> **Biosense Webster, Inc.** · Class II · device recall initiated 2017-06-14.

## Product

SMARTABLATE RF System Generator

## Reason for recall

Generator may inadvertently deliver RF energy if the foot pedal is placed in close proximity and oriented toward the Stereotaxis magnets.

## Distribution

Distributed to the following states: CA, CO,  GA, IL, IN, MI, NM, NY,  OH, PA, TN, TX, UT, WA, WI.      Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.

## Key facts

- **Recall number:** Z-0210-2018
- **Recalling firm:** Biosense Webster, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-14
- **Report date:** 2017-12-13
- **Termination date:** 2021-01-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irwindale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0210-2018

## Citation

> AI Analytics. FDA recall Z-0210-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0210-2018. Source: US FDA. Licensed CC0.

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