Z-0931-2013Class II

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of...

Name: Z-0931-2013 Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of...
Creator: Elekta, Inc.
Published: 2012-12-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-12-19 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process on 2012-12-19. FDA classified it as Class II and gives the reason as "The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name". 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-0931-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-19
Posted: 2013-03-10
Terminated: 2021-07-14
Recalling firm: Elekta Limited
Product: Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an "IMPORTANT FIELD SAFETY NOTICE" dated December 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The IFSN informs the user in the TPS, to give the different volumes different structure names. After importing the patient data set from the TPS, make sure that the structure contours are correct. Users are requested to return the signed acknowledgement. Contact your local Elekta office for questions regarding this notice.
Quantity in commerce: 164
Distribution: Nationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
Product codes and lots: 151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043, 151636, 151811, 151568, 151258, 151584, 151423, 151623, 151627, 151507, 151640, 151933, 151340, 151722, 151810, 151051, 151411, 151360, 151595, 151433, 151611, 152008, 151151, 151714, 151653, 151675, 151538, 152031, 151523, 151519, 151432, 151783, 151410, 151371, 151084, 151387, 151978, 151530, 151328, 151689, 151567, 151598, 151760, 151269, 151557, 151558, 151789, 151398, 151632, 152214, 151301, 151441, 151256, 151391, 151038, 151585, 151327, 151326, 151250, 151130, 151828, 151245, 151672, 105803, 151073, 151956, 152232, 151319, 151959, 151960, 151958, 151435, 151779, 151969, 151848, 151875, 151881, 151882, 151736, 152023, 152080, 152079, 152064, 151734, 151763, 152154, 151110, 151363, 151216, 151173, 151678, 151467, 151961, 151178, 152091, 152051, 152115, 152116, 151708, 152176, 152192, 152098, 152200, 152174, 152246, 152364, 152673, 152425, 151156, 151764, 151886, 151076, 151369, 152175, 105941

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0931-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0931-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-10

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)