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U.S. Department of Health and Human Services

Class 2 Device Recall Apex Addon microMLC

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  Class 2 Device Recall Apex Addon microMLC see related information
Date Initiated by Firm January 18, 2013
Date Posting Updated February 26, 2013
Recall Status1 Terminated 3 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/
Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
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 2
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 and Original Applicant = Elekta Limited