# FDA recall Z-1297-2019

> **Elekta Limited** · Class II · device recall initiated 2019-04-03.

## Product

Elekta Unity systems    Product Usage:  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. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

## Reason for recall

There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated.

## Distribution

Worldwide Distribution - US Nationwide in the states of Texas and Wisconsin.      Distribution internationally to Denmark, England, Germany, Italy, Netherlands

## Key facts

- **Recall number:** Z-1297-2019
- **Recalling firm:** Elekta Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-03
- **Report date:** 2019-05-15
- **Termination date:** 2023-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crawley, N/A, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2019

## Citation

> AI Analytics. FDA recall Z-1297-2019. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1297-2019. Source: US FDA. Licensed CC0.

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