# FDA recall Z-1109-2019

> **Elekta Limited** · Class II · device recall initiated 2019-03-12.

## Product

Elekta Unity, Image-Guided Radiation Therapy System    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

Users need to be aware when using these protocols for daily on line plan adaptation that:  1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images are based on data acquired around full expiration.  2) The display of the images in the Elekta Unity Application software does not provide information about the protocol used to acquire the image eg. with or without respiratory triggering.  Users must select an appropriate scan protocol that is representative of the respiratory phase used in the reference plan.

## Distribution

Worldwide Distribution - US Nationwide in the states of TX, NY, WI, and Denmark, Germany, Italy, Netherlands, Sweden, United Kingdom

## Key facts

- **Recall number:** Z-1109-2019
- **Recalling firm:** Elekta Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-12
- **Report date:** 2019-04-17
- **Termination date:** 2023-11-03

- **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-1109-2019

## Citation

> AI Analytics. FDA recall Z-1109-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1109-2019. Source: US FDA. Licensed CC0.

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