Z-1081-2014Class II

RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as...

Name: Z-1081-2014 RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as...
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 RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear... on 2013-11-25. FDA classified it as Class II and gives the reason as "During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value". 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-1081-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2014-03-06
Terminated: 2015-08-13
Recalling firm: Elekta Limited
Product: RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Field Safety Notice November 2013 to all affected customers. Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 041 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Important Field Safety Notice is in the process of being distributed to customers advising them of the recommended Quality Assurance checks to avoid/detect the problem. The permanent solution to this problem is currently been developed. Corrective Action #2 - Permanent Solution - All users of Desktop Pro software will be informed of a mandatory upgrade to Integrity 1.2 upon its release which will prevent calibration from being inverted. For questions regarding this recall call 770-300-9725.
Quantity in commerce: 489
Distribution: Worldwide Distribution - USA including AL, CA, CT, GA, FL, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, PA, TN, TX, VA, and Internationally to Argentina, Austria, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cuba, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Lebanon, Mexico, Morocco, Netherland, Nigeria, Pakistan, Panama, Peru, Philippines, Portugal, Russia, Serbia, Solvenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Vietnam, and Yemen.
Product codes and lots: R4.2, R5.0, R5.1, R6.0, R6.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1081-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1081-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-06

Product code IYE

K982713Class IIRt DesktopElekta Oncology Systems, Ltd. / cleared 1998-11-02

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)