Quick Facts at a Glance
- Recall Date
- December 12, 2025
- Hazard Level
- HIGH
- Brand
- Elekta
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Elekta
- Product type
- Radionuclide RT Treatment Planning System
- Model numbers
- Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 12, 2025
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Leksell GammaPlan system is a computer-based software designed for treatment planning of patients undergoing Leksell Gamma Knife therapy. Healthcare professionals utilize this software to create accurate treatment plans for radiation therapy.
Why This Is Dangerous
The software's failure to update obsolete references can lead to incorrect treatment plans that may result in irradiating the wrong patient area, posing a serious risk to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects patient treatment planning, which is critical in delivering effective radiation therapy. It may cause delays in patient care while alternative solutions are sought.
Practical Guidance
How to identify if yours is affected
- Check the software version and lot codes against the recall information provided.
- Confirm if your version is 11.3 or 11.4 and the respective lot codes.
- Contact your healthcare provider for any uncertainties regarding the software's safety.
Where to find product info
Lot codes and software version information can typically be found in the software's settings or installation details.
What timeline to expect
Expect a response within 4-6 weeks for refunds or replacements following the recall process.
If the manufacturer is unresponsive
- Document your communication attempts with Elekta.
- Consider reaching out via different channels such as phone and email.
- Keep records of all correspondence for future reference.
How to prevent similar issues
- Always ensure that software references are updated before beginning treatment planning.
- Regularly check for software updates and recall notices from manufacturers.
- Implement training for staff on how to verify correct software usage and updates.
Documentation advice
Keep copies of any receipts, correspondence with Elekta, and records of the software version being used.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall affects Leksell GammaPlan RT Treatment Planning Software versions 11.3 and 11.4. The affected lot codes include 07340048311878 (LGP 11.3) and 07340201502136 (LGP 11.4). This software was distributed globally, including across all U.S. states.
Key Facts
- Recall date: December 12, 2025
- Reported on: February 18, 2026
- Affected software versions: 11.3, 11.4
- Potential harm: Incorrect patient irradiation
- Stop using immediately
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.