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U.S. Department of Health and Human Services

Class 2 Device Recall Leksell Gamma Knife Perfexion with EXTEND Frame System

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  Class 2 Device Recall Leksell Gamma Knife Perfexion with EXTEND Frame System see related information
Date Initiated by Firm September 17, 2010
Date Posted October 28, 2010
Recall Status1 Terminated 3 on November 10, 2010
Recall Number Z-0163-2011
Recall Event ID 56852
510(K)Number K092083  
Product Classification System, radiation therapy, radionuclide - Product Code IWB
Product Leksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
Code Information Model #1009633 - Serial Numbers 6004, 6032 and 6078
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-670-2548
Manufacturer Reason
for Recall		 The anterior fixation bar of the EXTEND mouthpiece frontpiece may separate from the dental impression tray. This may result in reduced treatment accuracy.
FDA Determined
Cause 2		 Other
Action Elekta issued an Important Notice: Urgent Field Safety Notice dated September 17, 2010 concerning Field Change Order 10000202003-A342 "Important Notice regarding recall of mouthpieces for EXTEND system, to all users of the EXTEND system for LGK Perfexion. the letter identified the issue and associated potential hazard, and requested the identification and return of all affected mouthpieces, and confirmation of receipt of the letter. Elekta will arrange return and replacement through local service representatives. Customers can contact Elekta concerning this recall at 770 300 9725.
Quantity in Commerce 3 units
Distribution Nationwide Distribution: to the states of MO, VA, and WA.
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 and Original Applicant = ELEKTA INSTRUMENT AB
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