Z-1066-2012

Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process

Name: Z-1066-2012 Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process
Creator: Elekta, Inc.
Published: 2012-01-26
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-01-26 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process on 2012-01-26. The reason FDA records is "If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image...". 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-1066-2012
Status: Terminated
Initiated: 2012-01-26
Posted: 2012-02-21
Terminated: 2012-04-17
Recalling firm: Elekta Limited
Product: Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment process.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image panes continue to display the changed position.
Root cause tag: software
FDA root cause: Software design
Action: ELEKTA sent an Important Field Safety Notice (20001507042) dated January 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For questions regarding this recall call 770-670-2548
Quantity in commerce: 96 units
Distribution: Nationwide Distribution including AR, AZ, CA, CT, FL, 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: 152433, 152019, 151176, 152248, 152262, 152454, 105941, 151802, 152427, 151628, 151362, 152207, 151545, 151566, 152271, 152425, 152452, 152491, 151808, 152163, 152331, 151443, 151955, 152585, 152522, 151514, 151791, 151430, 151931. 105984, 151412, 152388, 151616, 151141, 152303, 151892, 151785, 152358, 152223, 152305, 152468, 151260, 152469, 152481, 152601, 152356, 152175, 152365, 152177, 152257, 151952, 152353, 152359, 152362, 152352, 152371, 152370, 151942, 151820, 151770, 151864, 151396, 152448, 151954, 151076, 151309, 152103, 152301, 151634, 151793, 152210, 152211, 151080, 152373, 152222, 152158, 152392, 151684, 152530, 152536, 151168, 151839, 151156, 151155, 151157, 152117, 151710, 152308, 152307, 152504, 151683, 151764, 151885, 152432, 151812, 152549.

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)