Z-1724-2014Class II

Synergy XVI Intended for radiation therapy treatment

Name: Z-1724-2014 Synergy XVI Intended for radiation therapy treatment
Creator: Elekta, Inc.
Published: 2014-04-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-04-23 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Synergy XVI Intended for radiation therapy treatment on 2014-04-23. FDA classified it as Class II and gives the reason as "XVI can incorrectly calculate the target position of the treatment table". 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-1724-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-23
Posted: 2014-06-16
Terminated: 2017-07-17
Recalling firm: Elekta Limited
Product: Synergy XVI Intended for radiation therapy treatment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: XVI can incorrectly calculate the target position of the treatment table.
Root cause tag: software
FDA root cause: Software design
Action: Elekta is responsible for the correction of all products with this defect. 1. Notifications regarding the possibility of this software error and subsequent table location error and potential hazards have been sent out. The notifications include steps to take to reduce the possibility of the occurrence of an injury. 2. A software correction has been released for some versions of the XVI software. All versions of software with this error will be corrected by the end of July 2014. 3. The software correction will enable verification that values have been assigned to table position parameters; failure to pass verification will inhibit the system. The software correction will also detect internal communication errors (incomplete registrations) and inhibit the system when those errors are detected. 4. The update will be mandatory and will be made at no cost to the users. CDRH approves this CAP. You may proceed with implementation of the CAP. For further questions please call (770) 670-2422.
Quantity in commerce: 380 US
Distribution: Worldwide Distribution - USA including the states of AZ, CT, IA, OH, MD, MI, MN, NV, TX and VA., and the countries of India, Ireland, Malta, Netherlands, South Africa and UK.
Product codes and lots: XVI R4.0 to R4.2.1, R4.5.0, R4.5.1, and R5.0.0 to R5.0.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1724-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1724-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-16

Product code IYE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)