Z-2340-2012Class II

Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of...

Name: Z-2340-2012 Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of...
Creator: Elekta, Inc.
Published: 2012-07-27
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-07-27 / Terminated / root cause: labeling and UDI

FDA source

Elekta, Inc. began a recall of Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such... on 2012-07-27. FDA classified it as Class II and gives the reason as "Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2340-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-09-10
Terminated: 2014-10-06
Recalling firm: Elekta Limited
Product: Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Information released with the product Agility did not originally contain information on compatibility with the add-on Dynamic Multileaf Collimator Apex.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: ELEKTA sent an Important Field Safety Notice, FCO Ref: 20001405000 dated July 7, 2012, to current Agility users and a separate notice FCO Ref: 20001407026 for current Apex users who may be in the process of considering an upgrade to Agility. Both notices made it clear that Apex has not been integrated or classified as compatible for use with Agility. Users are advised not to use Apex with Agility. For questions regarding this recall call 770-300-9725.
Quantity in commerce: 2
Distribution: Nationwide Distribution including DC & MD
Product codes and lots: 152599 and 152678

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2340-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2340-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)