Recall Z-1719-2015 ยท IWB System, Radiation Therapy, Radionuclide
Elekta, Inc.
Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
| Date | Jun 5, 2015 (initiated Jun 1, 2015) |
| Status | Terminated |
| Reason | Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2. |
| Root cause | Software in the Use Environment |
| Action | The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTICE 100-01-102-015" to all customers on 6/1/2015. The notice described the product, problem and actions to be taken. The customers were instructed to not use drag-and-drop to fuse images as a solution until a permanent fix can be developed and implemented on all affected devices. A solution is in development that will resolve the issue and is expected to be released September 2015. Elekta Service will then work with customers to implement on affected devices - estimated 6 month completion. Customers were also instructed to complete |
| Quantity | 10 |
| Distribution | Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103093 | LEKSELL GAMMAPLAN Elekta Instrument AB, Dec 21, 2010 |