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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 systemsee related information
Date Initiated by FirmNovember 06, 2009
Date PostedApril 05, 2010
Recall Status1 Terminated 3 on December 14, 2010
Recall NumberZ-1232-2010
Recall Event ID 55063
510(K)NumberK063512 
Product Classification System, radiation therapy, radionuclide - Product Code IWB
ProductLeksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
Code Information Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6049, 6053, 6054, 6056, 6057, 6059 and 6061.
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		There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.
FDA Determined
Cause 2		Software design
ActionElekta, Inc. issued a Field Change Order 200 091 titled "Update Frame Adapter with New Frame Fixation Axle" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device. For further information, contact Elekta, Inc. at 1-770-300-9725.
Quantity in Commerce32 units
DistributionNationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, UT and VA.
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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