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U.S. Department of Health and Human Services

Class 2 Device Recall Leksell Gamma Knife Perfexion

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 Class 2 Device Recall Leksell Gamma Knife Perfexionsee related information
Date Initiated by FirmJuly 02, 2007
Date PostedMarch 17, 2010
Recall Status1 Terminated 3 on March 25, 2010
Recall NumberZ-1158-2010
Recall Event ID 54554
510(K)NumberK063512 
Product Classification Radionuclide Radiation Therapy System - Product Code IWB
ProductLeksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Code Information Serial Numbers: 6002, 6003, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, and 6030.
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		Need to modify the closing speed of the shielding doors in the event of an emergency exit
FDA Determined
Cause 2		Other
ActionA field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.
Quantity in Commerce19
DistributionWorldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
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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