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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 Perfexion see related information
Date Initiated by Firm July 02, 2007
Date Posted March 17, 2010
Recall Status1 Terminated 3 on March 25, 2010
Recall Number Z-1158-2010
Recall Event ID 54554
510(K)Number K063512  
Product Classification Radionuclide Radiation Therapy System - Product Code IWB
Product Leksell 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 Contact Thomas 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
Action A 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 Commerce 19
Distribution Worldwide 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 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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