PlainRecordsBrand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment… and 1 more product
- 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…
- Status
- Ongoing
- 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…
- Enforcement report date
- Feb. 18, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Elekta, Inc.
- 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.
- Distribution pattern
- 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.
What this record is about
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“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.”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., FDA enforcement report, 2026-02-18. The caption is the record's own words.
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FDA device name: System, Planning, Radiation Therapy Treatment
Distributed in (FDA's record): Alaska Arizona California Colorado Florida Georgia Hawaii Illinois Iowa Louisiana Massachusetts Michigan Minnesota New Jersey New Mexico New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina South Dakota Tennessee Texas Utah Virginia Washington West Virginia Wisconsin and nationwide
2 products in this recall
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1…
- 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.
- Quantity
- N/A
- Codes and lots
- Lot Code: 07340048311236 (LGP 11.1)
- Recall started
- Dec. 12, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- System, Planning, Radiation Therapy Treatment
- Root cause (FDA)
- Use error
- What the company told customers
- 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
- Recall number
- Z-1339-2026
Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3…
- 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.
- Quantity
- N/A
- Codes and lots
- Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
- Recall started
- Dec. 12, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- System, Planning, Radiation Therapy Treatment
- Root cause (FDA)
- Use error
- What the company told customers
- 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
- Recall number
- Z-1340-2026
This recall among the others
- FDA's enforcement report came 68 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
- Elekta: 8 other recalls or notices on this site in the three years before this one (from Feb. 19, 2023).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1339-2026, Z-1340-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1339-2026, Feb. 18, 2026. "Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment… and 1 more product." PlainRecords, https://plainrecords.com/recall/device/z-1339-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections