Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiati
FDA device recall Z-1719-2015 · posted 2015-06-05 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
- Action taken
- 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 and return the IMPORTANT FIELD SAFETY NOTICE ACKNOWLEDGEMENT form to your local Elekta Office or Representative as soon as possible and within 30 days at the latest. If you have any queries about this Notice, please contact your local Elekta representative or the Global Post market Surveillance Manager at 770-300-9725 or email: Elekta_Global_PMS@elekta.com.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 10
- Distribution
- Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
- Date initiated
- 2015-06-01
- Date posted
- 2015-06-05
- Date terminated
- 2016-01-12
- Location
- Atlanta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEKSELL GAMMAPLAN (K103093) | Elekta Instrument AB | 2010-12-21 |