# FDA recall Z-2289-2020

> **Elekta, Inc.** · Class II · device recall initiated 2020-04-30.

## Product

Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.

## Reason for recall

potential risk that Legionella may be present in the Unity machine room, specifically the heat exchanger condensation collection tray.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of PA, WI, NY, TN, NJ, IA, TX,  and the countries of Australia, Canada, China, Denmark, Germany, Hong Kong, Italy, Netherlands, Sweden, Switzerland, Thailand, Turkey, UK.

## Key facts

- **Recall number:** Z-2289-2020
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-30
- **Report date:** 2020-06-17
- **Termination date:** 2021-08-04

- **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-2289-2020

## Citation

> AI Analytics. FDA recall Z-2289-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2289-2020. Source: US FDA. Licensed CC0.

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