Leksell GammaPlan recallZ-1339-2026 · Elekta, Inc. · initiated Dec 12, 2025

Why it was recalled

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.

FDA root cause category: Use error

What the company is doing

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 [email protected]

Recall details

Recall number

Z-1339-2026

Status

Open, Classified

Initiated by the company

Dec 12, 2025

Posted by the FDA

Feb 10, 2026

Recalling firm

Elekta, Inc.

Product code

MUJ

FDA submissions

K151666

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.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Leksell GammaPlan 1529980

  Elekta Instrument AB · System, radiation therapy, radionuclide
  1 recall0 reports

Product lines

• Leksell GammaPlanElekta Instrument AB · 2 models · 1 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 98212).

• Z-1340-2026 · Open, Classified
  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…