Z-1061-2014Class II

Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant...

Name: Z-1061-2014 Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant...
Creator: Elekta, Inc.
Published: 2013-11-25
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-11-25 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical... on 2013-11-25. FDA classified it as Class II and gives the reason as "Potential collision risk when using XVI and external beam shaping devices". 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-1061-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2014-02-20
Terminated: 2016-12-14
Recalling firm: Elekta Limited
Product: Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potential collision risk when using XVI and external beam shaping devices.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Field Safety Notice dated November 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Corrective Action #1 - Potential collision risk when using XVI and external beam shaping devices. (Only software version R4.2.1 from this notice are applicable to this recall). Recommendations to Users - Monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button on the FKP. To correct the error - (1) Restart XVI. (2) Put the patient in their initial setup position. (3) Scan the patient again, and continue the usual workflow. Always monitor the patient when do RATM. When you do Volume View acquisitions with the Apex collimator attached, make sure that the stop angle of the Volume View parameters is in the lower half of the gantry rotation. This decreases the risk of a collision with the patient. Read and follow the advice in the Important Field Safety Notice (200 01 507 081) and acknowledge receipt to your Elekta representative within 30 days. Corrective Action #2 -Permanent Solution - XVI Risk control measure - changes to the software to prevent table movement if the start position has not been recorded correctly. Recommendations for changes to product are - (1) Table zero should default to NIHII not zero. (2) Check that the table zero is valid because calculating absolute table positions. (3) Check prescribed table position is not more than 2.5cm from actual table position when permitting ASU from outside room. Target Release XVI R.4.2.2 estimated for release April 2014. For further questions please call (770) 300-9725.
Quantity in commerce: 312
Distribution: Worldwide Distribution: US (nationwide) including 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, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, WI, DC, and Internationally to: Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Pakistan, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Taiwan, Thailand, and United Kingdom.
Product codes and lots: Model 4.2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1061-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1061-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)