# FDA recall Z-1980-2019

> **Elekta, Inc.** · Class II · device recall initiated 2019-06-24.

## Product

Elekta Unity, Image-Guided Radiation Therapy System    Elekta Unity using Magnetic Resonance Imaging 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

The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA.

## Distribution

US Distribution to states of: TX & WI, and Internationally to: Canada, Denmark, Germany, Italy, Netherlands, Sweden, and the UK.

## Key facts

- **Recall number:** Z-1980-2019
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-24
- **Report date:** 2019-07-24
- **Termination date:** 2021-04-01

- **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-1980-2019

## Citation

> AI Analytics. FDA recall Z-1980-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1980-2019. Source: US FDA. Licensed CC0.

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