The Recall Desk

FDA (Devices) recall action 98212

Elekta, Inc. recalled 2 products on 2026-02-18

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-02-18
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2026-02-18

    GammaPlan 11.1 recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan version 11.1 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    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.
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2026-02-18

    GammaPlan software recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan versions 11.3 and 11.4 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    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.
    Category
    Distribution
    33 states