Class 2 Device Recall Leksell GammaPlan 11.1

• Date Initiated by Firm: June 27, 2018
• Create Date: May 23, 2019
• Recall Status: Open, Classified
• Recall Number: Z-1412-2019
• Recall Event ID: 82662
• 510(K)Number: K173791
• Product Classification: System, radiation therapy, radionuclide - Product Code IWB
• Product: Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
• Code Information: Software Version 11.1
• FEI Number: 3002806883
• Recalling Firm/ Manufacturer: Elekta Instrument AB; Kungstensgatan 18; Stockholm Sweden
• Manufacturer Reason for Recall: The margin tool in Leksell GammaPlan 11.1 systematically overestimates margin in certain areas of the volume.
• FDA Determined Cause: Software design
• Action: Elekta initially notified customers on about 06/27/2018 via "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" LETTER. Instructions included to post the recall notice in a place accessible to all users, e.g. Instructions for Use, until the recall action is closed, advise the appropriate personnel working with the affected device of the recall and the content of the recall notification letter, and complete and return the Acknowledgement Form. Elekta updated their recall strategy on about 11/21/2018 and will be providing all affected customers with software upgrade 11.1.1. Electa service engineers will be pro-actively reaching out to customers to organize a date for installation on all affected devices. An updated recall notification was not sent to customers.
• Quantity in Commerce: 52 devices
• Distribution: Worldwide Distribution - US Nationwide distribution to GA, MD, NJ, PA, PR, WA. International distribution to Australia, Belgium, France, Germany, Hong Kong, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Romania, Russian Federation, Spain, Turkey, 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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