Z-0320-2012

Elekta Synergy XVI R.4.5 and R4.6

Name: Z-0320-2012 Elekta Synergy XVI R.4.5 and R4.6
Creator: Elekta, Inc.
Published: 2011-10-14
License: https://open.fda.gov/license/

Elekta Limited / initiated 2011-10-14 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation therapy treatment process on 2011-10-14. The reason FDA records is "The software did not operate as expected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0320-2012
Status: Terminated
Initiated: 2011-10-14
Posted: 2011-12-01
Terminated: 2014-11-03
Recalling firm: Elekta Limited
Product: Elekta Synergy XVI R.4.5 and R4.6 ProducT Usage: To be used as part of radiation therapy treatment process.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The software did not operate as expected.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an IMPORTANT NOTICE letter dated October 14, 2011 to all affected consignees. The letter identified the affected product, the problem, and the actions to be taken. This notice contained precautionary measures that are required for the operation of the equipment. The notice advise all customers to follow any instructions or recommendations covered in the Notice. The notice instructs Users to file this document in the Important Notice section of the appropriate User Manual. For questions contact your local Elekta representative.
Quantity in commerce: 77
Distribution: Nationwide Distribution (USA) - including the states of: AZ, CA, CT, GA, ID, IL, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OK, OR, PA, RI, TN, VA, WA, WI and Puerto Rico
Product codes and lots: 105984, 151076, 151080, 151141, 151155, 151156, 151157, 151168, 151260, 151362, 151396, 151412, 151442, 151545, 151566, 151616, 151628, 151683, 151684, 151710, 151764, 151785, 151802, 151812, 151839, 151885, 151892, 151931, 151942, 151952, 151954, 151955, 152019, 152117, 152158, 152163, 152177, 152207, 152210, 152211, 152222, 152223, 152248, 152257, 152262, 152271, 152301, 152303, 152305, 152307, 152308, 152331, 152352, 152353, 152356, 152358, 152359, 152362, 152365, 152370, 152371, 152373, 152388, 152392, 152425, 152432, 152433, 152448, 152452, 152454, 152468, 152469, 152481, 152491, 152504, 152522, 152536

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)