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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 Systemsee related information
Date Initiated by FirmSeptember 17, 2010
Date PostedOctober 28, 2010
Recall Status1 Terminated 3 on November 10, 2010
Recall NumberZ-0163-2011
Recall Event ID 56852
510(K)NumberK092083 
Product Classification System, radiation therapy, radionuclide - Product Code IWB
ProductLeksell Gamma Knife Perfexion with EXTEND Frame System, manufactured by Electa Instrument AB, Stockholm, Sweden.
Code Information Model #1009633 - Serial Numbers 6004, 6032 and 6078
FEI Number 1037831
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information ContactThomas 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
ActionElekta 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 Commerce3 units
DistributionNationwide Distribution: to the states of MO, VA, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IWB
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