Class 2 Device Recall Leksell GammaPlan

• Date Initiated by Firm: June 01, 2015
• Date Posted: June 05, 2015
• Recall Status: Terminated on January 12, 2016
• Recall Number: Z-1719-2015
• Recall Event ID: 71295
• 510(K)Number: K103093
• Product Classification: System, radiation therapy, radionuclide - Product Code IWB
• Product: Laksell GammaPlan, a computer based dose planning system specifically designed for use with Leksell Gamma Knife, radiation therapy treatment.
• Code Information: Software 10.2
• FEI Number: 1037831
• Recalling Firm/ Manufacturer: Elekta, Inc.; 400 Perimeter Center Ter Ne; Ste 50; Atlanta GA 30346-1227
• For Additional Information Contact: Linda Wetsel; 770-300-9725
• Manufacturer Reason for Recall: Memory can become corrupted when creating a fused study via drag and drop in Leksell GammaPlan 10.2.
• FDA Determined 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 in Commerce: 10
• Distribution: Worldwide Distribution: US (nationwide) including states: IL, OH, PA, TX, and WI; and countries of: Germany, Japan and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IWB