# FDA recall Z-0706-2019

> **Elekta Limited** · Class II · device recall initiated 2019-01-04.

## Product

Elekta Unity

## Reason for recall

In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

## Distribution

TX and WI, Germany, Denmark, Netherlands, United Kingdom

## Key facts

- **Recall number:** Z-0706-2019
- **Recalling firm:** Elekta Limited
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2019-01-04
- **Report date:** 2019-01-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0706-2019

## Citation

> AI Analytics. FDA recall Z-0706-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0706-2019. Source: US FDA. Licensed CC0.

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