Z-1084-2014Class II

Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital...

Name: Z-1084-2014 Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital...
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 Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with... 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-1084-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-25
Posted: 2014-03-06
Terminated: 2017-11-08
Recalling firm: Elekta Limited
Product: Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
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: Corrective Action #1 - Release of Important Field Safety Notice 200 01 502 043 - "Recommended quality assurance after a calibration procedure" Released 25 November, 2013. Corrective Action #2 - Permanent Solution - All users of Integrity 3.1 software will be informed or a mandatory upgrade to Integrity 3.2 upon its release which will prevent calibration from being inverted. Target Release for Integrity 3.2 will be available at the end of February 2014.
Quantity in commerce: 300
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AL, AK, AZ, CA, CT, FL, GA, IL, KY, LA, MD, MA, MI, MO, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, and WY, and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Cuba, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan , Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Vietnam.
Product codes and lots: Model 3.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1084-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1083-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-06
Z-1084-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-06
Z-1085-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-06

Product code IYE

K121328Class IIAgilityElekta , Ltd. / cleared 2012-06-12

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)