Z-0305-2012

Elekta Synergy XVI 4.5

Name: Z-0305-2012 Elekta Synergy XVI 4.5
Creator: Elekta, Inc.
Published: 2011-03-09
License: https://open.fda.gov/license/

Elekta Limited / initiated 2011-03-09 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner on 2011-03-09. The reason FDA records is "If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs...". 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-0305-2012
Status: Terminated
Initiated: 2011-03-09
Posted: 2011-11-29
Terminated: 2012-08-09
Recalling firm: Elekta Limited
Product: Elekta Synergy XVI 4.5 Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends the delivered MUs to MOSAIQ a a zero value.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an IMPORTANT NOTICE letter dated March 9, 2011 to affected customers. The notice identified the product, the problem, and the corrective action to be taken by the customer. The notice advise all customers to follow any instructions or recommendations covered in the Notice. For questions call +44(0)1293 654200.
Quantity in commerce: 56
Distribution: Nationwide Distribution (USA) including the states of: AZ, CA, GA, IL, LA, MD, MA, MI, MN, NJ, NY, NC, OH, PA, TN, VA, WI and Puerto Rico
Product codes and lots: 152019, 152448, 151076, 151954, 152454, 152117, 152452, 152393, 152394, 151942, 152163, 151955, 152176, 152222, 151931, 152388, 151141, 152365, 152303, 152358, 152353, 152359, 152352, 152362, 152305, 152468, 152481, 152469, 151812, 152432, 151260, 151952, 152370, 151396, 152301, 152248, 152425, 151155, 151156, 151157, 151412, 105984, 152307, 152308. 151443, 151545, 151628, 152207, 152271, 152373, 152371, 151080, 152211, 152158, 152392, 152331

Product code IYE

K051932Class IIElekta Synergy; Elekta Synergy S and Xvir3.5Elekta, Inc. / cleared 2005-08-12

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)