FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
- Recall number
- Z-1719-2015
- Recalling firm
- Elekta, Inc.
- Product
- Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
- Status
- Terminated
- Initiated
- 2015-06-01
- Posted
- 2015-06-05
- Terminated
- 2016-01-12
- 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 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.
- Quantity
- 10
- Distribution
- Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
- Lot, serial or model codes
- Software 10.2
- 510(k) numbers
- ["K103093"]
- PMA numbers
- not on file
- Product code
- IWB
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28