Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based Recalled by Elekta Instrument AB Due to The margin tool in Leksell GammaPlan 11.1 systematically...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elekta Instrument AB directly.
Affected Products
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Quantity: 52 devices
Why Was This Recalled?
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Elekta Instrument AB
Elekta Instrument AB has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report