# FDA recall Z-1340-2026

> **Elekta, Inc.** · Class II · device recall initiated 2025-12-12.

## Product

Brand Name: Leksell GammaPlan  Product Name: Radionuclide RT Treatment planning system  Software Version: 11,3, 11.4  Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.

## Reason for recall

Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference.  This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AZ, CA, CO, ST, FL, GA, HI, IA, IL, LA, MA, MI, MN. MO, NC, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Algeria, Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Hong Kong, India, Iran, Iraq, Italy, Japan, Jordan, Republic of Korea, Kuwait, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Pakistan, Peru, Poland, Romania, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, and Vietnam.

## Key facts

- **Recall number:** Z-1340-2026
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-12
- **Report date:** 2026-02-18

- **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-1340-2026

## Citation

> AI Analytics. FDA recall Z-1340-2026. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1340-2026. Source: US FDA. Licensed CC0.

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