Z-0342-2012

Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process

Name: Z-0342-2012 Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process
Creator: Elekta, Inc.
Published: 2011-10-20
License: https://open.fda.gov/license/

Elekta Limited / initiated 2011-10-20 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process on 2011-10-20. The reason FDA records is "A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0342-2012
Status: Terminated
Initiated: 2011-10-20
Posted: 2011-12-01
Terminated: 2012-08-09
Recalling firm: Elekta Limited
Product: Elekta Synergy XVI X-ray Volume Imaging System To be used as part of radiation therapy treatment process.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Product code IYE

K100115Class IIXvi R4.5Elekta , Ltd. / cleared 2010-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)