—#137250

Product

Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K103093
Affected lot / code info: Software 10.2

Why it was recalled

Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.

Root cause (FDA determination)

Software in the Use Environment

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter Ne, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.

Timeline

Recall initiated: 2015-06-01
Posted by FDA: 2015-06-05
Terminated: 2016-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.