HIGH

Elekta Recalls Radionuclide RT Treatment Planning System Over High-Risk Error

Elekta recalled the Leksell GammaPlan RT Treatment Planning System on December 12, 2025, due to a software error. This defect may lead to incorrect patient irradiation if not detected. Healthcare providers must stop using the software immediately.

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

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

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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.

The Hazard

The software error arises when users do not update an obsolete reference before defining a new stereotactic reference. This oversight could lead to treatment plans that incorrectly target patient locations.

What to Do

Immediately stop using the Leksell GammaPlan software. Follow recall instructions from Elekta, Inc. or your healthcare provider.

Contact Information

For further assistance, contact Elekta, Inc. through their official website or customer service hotline.

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

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeRadionuclide RT Treatment Planning System
Sold At
Multiple Retailers

Product Details

Brand
Model Numbers
Lot Code: 07340048311878 (LGP 11.3) 07340201502136 (LGP 11.4)
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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