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.
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. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 15, 2026.
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Check if you qualifyKey facts
- Date announced
- February 18, 2026
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
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. was recalled because 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.. If you have this product, stop using it until you verify your lot or model details.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
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.
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Elekta, inc.
- Category
- medical
- Source agency
- FDA
- Announced
- February 18, 2026
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
| # | Model |
|---|---|
| 1 | Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4) |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1Stop using the affected product until you verify whether your item is impacted.
- 2Check the official recall notice and match your model, lot, or serial details.
- 3Follow the official instructions for repair, replacement, refund, or disposal.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- February 18, 2026
- Last reviewed by RecallRadar
- March 15, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4).
What is the remedy for this recall?
Follow the official instructions for repair, replacement, refund, or disposal on the elekta, inc. recall page.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://api.fda.gov/device/enforcement.json?search=recall_number:Z-1340-2026&limit=1
Keep browsing with these internal hubs: elekta, inc. recall hub and Medical recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- February 18, 2026
- Source agency
- FDA
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