# FDA recall Z-1412-2019

> **Elekta Instrument AB** · Class II · device recall initiated 2018-06-27.

## Product

Leksell GammaPlan 11.1    Product Usage:  Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

## Reason for recall

The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

## Distribution

Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA.    International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-1412-2019
- **Recalling firm:** Elekta Instrument AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-06-27
- **Report date:** 2019-05-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stockholm, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2019

## Citation

> AI Analytics. FDA recall Z-1412-2019. Retrieved 2026-08-01 from https://api.ai-analytics.org/recall/Z-1412-2019. Source: US FDA. Licensed CC0.

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