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Elekta Instrument AB recalls Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife
Recalled May 29, 2019 · FDA recall Z-1412-2019 · Elekta Instrument AB
Hazard
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume. · FDA Class II
Units
52 devices
Sold at
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.
Description
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Product
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Manufacturer(s)
Elekta Instrument AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →