Device product
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Z-1412-2019
Product summary
- Event
- Event 82662
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 52 devices
- Official record key
device-enforcement:Z-1412-2019
Official wording
Reason: The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
Code information: Software Version 11.1
Distribution pattern: 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.
Derived failure modes
-
Unknown
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.