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U.S. Department of Health and Human Services

Class 2 Device Recall Synergy XVI kV Generator

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  Class 2 Device Recall Synergy XVI kV Generator see related information
Date Initiated by Firm October 20, 2011
Date Posted December 01, 2011
Recall Status1 Terminated 3 on August 09, 2012
Recall Number Z-0342-2012
Recall Event ID 60497
510(K)Number K100115  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Elekta Synergy XVI X-ray Volume Imaging System

To be used as part of radiation therapy treatment process.
Code Information G30369, G29103, G34727, G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668, G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676, G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035, G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843, G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980, G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558, G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397, G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522, G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366, G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285, G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338, G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347, G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691, G34980, G34983, G34726
Recalling Firm/
Manufacturer		 Elekta, Inc.
4775 Peachtree Industrial Blvd
Bldg 300, #300
Norcross GA 30092-3011
For Additional Information Contact Thomas Valentine
770-300-9725
Manufacturer Reason
for Recall		 A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Elekta, issued a "FIELD CHANGE ORDER MANDATORY ACTION" notice dated October 20, 2011 to its customers to add fuse protection for the kV transformers. The notice describes the product, problem, provides instructions and procedures and actions to be taken. The customers were instructed to follow any instructions or recommendations covered in the notice and to file the document in the Important Notice section of the appropriate User Manual. Elekta will contact the customer if the FCO is applicable to their kV generator. If you have any questions, call 770-300-9725.
Quantity in Commerce 123
Distribution Nationwide distribution: USA including states of: AL, AK, AZ, CA, CT, FL, GA, IL, IA, KY, MD, MS, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TX, VT, VA, WA, WV, WI, Puerto Rico, & DC.
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 = IYE and Original Applicant = ELEKTA LTD.
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