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U.S. Department of Health and Human Services

Class 2 Device Recall Radionuclide Radiation Therapy System

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  Class 2 Device Recall Radionuclide Radiation Therapy System see related information
Date Initiated by Firm May 30, 2007
Date Posted April 05, 2010
Recall Status1 Terminated 3 on December 28, 2010
Recall Number Z-1231-2010
Recall Event ID 54886
510(K)Number K063512  
Product Classification System, radiation therapy, radionuclide - Product Code IWB
Product Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.

Indicated for use in the stereotactic irradiation of intracranial structures.
Code Information Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032. 
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
There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.
FDA Determined
Cause 2
Software design
Action Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.
Quantity in Commerce 18 units
Distribution Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.
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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