Class 2 Device Recall Apex Addon microMLC

• Date Initiated by Firm: January 18, 2013
• Date Posted: February 26, 2013
• Recall Status: Terminated on May 08, 2014
• Recall Number: Z-0885-2013
• Recall Event ID: 64213
• 510(K)Number: K111676
• Product Classification: Block, beam-shaping, radiation therapy - Product Code IXI
• Product: Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
• Code Information: 152652
• 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: If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
• FDA Determined Cause: Employee error
• Action: Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725.
• Quantity in Commerce: 1
• Distribution: Nationwide Distribution including TX
• 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 = IXI