Z-1412-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- June 27, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 devices
Product Description
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Reason for Recall
The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
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.
Code Information
Software Version 11.1