medical Class II Updated 2019-05-29

Elekta Instrument AB recalls Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan

Recalled Product

Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.


Hazard / Issue

The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Version 11.1
View official government recall

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