Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Produ

FDA device recall Z-1340-2026 · posted 2026-02-10 · Open, Classified

Recall details

Recalling firm

Elekta, Inc.

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.

Action taken

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

Root cause

Use error

Status

Open, Classified

Product code

MUJ

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

Date initiated

2025-12-12

Date posted

2026-02-10

Location

Atlanta, GA

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