Device product
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
Z-1719-2015
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 71295
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-1719-2015
Official wording
Reason: Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
Code information: Software 10.2
Distribution pattern: Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
Derived failure modes
-
Unknown
Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.