Z-0350-2011

Elekta Synergy XVI

Name: Z-0350-2011 Elekta Synergy XVI
Creator: Elekta, Inc.
Published: 2010-09-01
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-09-01 / Terminated

FDA source

Elekta, Inc. began a recall of Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner on 2010-09-01. The reason FDA records is "It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0350-2011
Status: Terminated
Initiated: 2010-09-01
Posted: 2015-06-26
Terminated: 2010-12-14
Recalling firm: Elekta Limited
Product: Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode.
FDA root cause: Other
Action: Elekta sent an "Important Notice A340" dated September 1, 2010 to all customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to make a decision if XVI or MOSAIQ does the corrective table movement; configure and ensure that the system only uses RATM or CMA for the corrective table movement, when in SYNERGISTIQ mode, and complete and return the IMPORTANT NOTICE Confirmation of Receipt form via fax at +44(0)1293 654401. If you have any questions contact your local service representative at +44(0)1293 654200.
Quantity in commerce: 23 units
Distribution: Nationwide distribution: AZ, CA, DC, IL, KY, MA, MI, MS, NV, NY, OH, OR, PA, VT, and WV.
Product codes and lots: Serial Numbers 152019, 151866, 151259, 151522, 151969, 152192, 152126, 152115, 152116, 152176, 151931, 152177, 151523, 151626, 151842, 152158, 152079, 152080, 151250, 152064, 152207, 151628, and 151362

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)