# FDA recall Z-2473-2020

> **Elekta, Inc.** · Class II · device recall initiated 2019-12-18.

## Product

Elekta Unity, Image-Guided Radiation Therapy System

## Reason for recall

There have been reports of excessive heating in the MRL Gradient Connection Module.

## Distribution

Distributed in US - PA, NY, and IA.  Distributed ROW - Australia, Canada, China, Switzerland, Denmark, Hong Kong, Italy, Netherlands, Sweden, Thailand, Turkey, UK.      There was no government/military distribution.

## Key facts

- **Recall number:** Z-2473-2020
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-18
- **Report date:** 2020-07-08
- **Termination date:** 2021-06-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2473-2020

## Citation

> AI Analytics. FDA recall Z-2473-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2473-2020. Source: US FDA. Licensed CC0.

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