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U.S. Department of Health and Human Services

Class 2 Device Recall Elekta Leksell Gamma

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 Class 2 Device Recall Elekta Leksell Gammasee related information
Date Initiated by FirmJune 23, 2011
Date PostedNovember 30, 2011
Recall Status1 Terminated 3 on January 31, 2012
Recall NumberZ-0307-2012
Recall Event ID 60125
510(K)NumberK973441 
Product Classification System, radiation therapy, radionuclide - Product Code IWB
ProductElekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
Code Information 6107 and 6115
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 is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.
FDA Determined
Cause 2		Labeling False and Misleading
ActionElekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.
Quantity in Commerce2
DistributionNationwide Distribution (USA) - including the states of: NM and WA
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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