Elekta, Inc.: Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

Recall number

Z-1339-2026

Recalling firm

Elekta, Inc.

Product

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.

Status

Open, Classified

Initiated

2025-12-12

Posted

2026-02-10

Terminated

not on file

Reason

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.

Root cause

Use error

Action

On 12/12/2025, the firm sent an "IMPORTANT FIELD SAFETY NOTIFICATION/URGENT: MEDICAL DEVICE CORRECTION" letter via email to customers informing them that when Defining a new stereotactic reference in an examination for a frame treatment while failing to first change an already defined obsolete stereotactic reference (representing a non-current frame fitting) to a pre-plan reference, may result in a treatment plan that irradiates the wrong patient location if the resulting inconsistent alignment between the stereotactic references is not detected by the user. Customers are instructed to: If the stereotactic reference for a frame treatment must be changed prior to plan approval (e.g. due to a change of frame fitting), make sure to first change the already defined obsolete stereotactic reference to a pre-plan reference before defining the new stereotactic reference. By so doing, the treatment examination is automatically updated according to the new stereotactic reference when it is defined. Do not combine the use of a stereotactic CBCT reference with other stereotactic references for treatments with a frame. This specific recommendation for CBCT is motivated by the increased likelihood of failure for users to detect an inconsistent stereotactic CBCT reference relative to other stereotactic references, compared to MR and CT image studies, which are typically displayed and explored throughout the planning process. Post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. " Advise the appropriate personnel, working with this product, on the content of this letter. For Questions - Contact Elekta Care Support at 855-693-5358 or email Application.Support.NA@elekta.com

Quantity

not on file

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.

Lot, serial or model codes

Lot Code: 07340048311236 (LGP 11.1)

510(k) numbers

["K151666"]

PMA numbers

not on file

Product code

MUJ

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy