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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 FirmNovember 09, 2008
Date PostedApril 05, 2010
Recall Status1 Terminated 3 on December 28, 2010
Recall NumberZ-1230-2010
Recall Event ID 54564
510(K)NumberK063512 
Product Classification System, radiation therapy, radionuclide - Product Code IWB
ProductLeksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os 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 and 6036.
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		Radiation unit doors could close too fast on emergency exit.
FDA Determined
Cause 2		Software design
ActionField Change Order 200 070 "MCU CS SW 8.3" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product. For further information, contact Elekta, Inc. at 1-770-300-9725.
Quantity in Commerce19 units
DistributionNationwide Distribution -- AR, AZ, CA, FL, IL, MI, MN, MS, MO, NJ, OH, OR, PA, 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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