FDA-Device2019-05-29Class II
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Elekta Instrument AB
Hazard
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Sold states
Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, United Kingdom.
Affected count
52 devices
Manufactured in
Kungstensgatan 18, N/A, Stockholm, N/A, Sweden
Products
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1412-2019Don't want to check this manually?
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