Z-0885-2013Class II

Elekta, Apex add-on Micro MLC, collimator for radiation therapy

Name: Z-0885-2013 Elekta, Apex add-on Micro MLC, collimator for radiation therapy
Creator: Elekta, Inc.
Published: 2013-01-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-01-18 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Elekta, Apex add-on Micro MLC, collimator for radiation therapy on 2013-01-18. FDA classified it as Class II and gives the reason as "If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0885-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-18
Posted: 2013-02-26
Terminated: 2014-05-08
Recalling firm: Elekta Limited
Product: Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
Product code: IXI Block, Beam-Shaping, Radiation Therapy
Reason for recall: If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12 restrictions.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Elekta sent an Important Field Safety Notice Field Safety Notice FCO Ref: 20001407029 "Important information for the safe and satisfactory operation of Apex" to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obey all the applicable instructions, warning, and cautions in the user documentation for each piece of equipment. For questions regarding this recall call 770-300-9725.
Quantity in commerce: 1
Distribution: Nationwide Distribution including TX
Product codes and lots: 152652

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0885-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0885-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-26

Product code IXI

K111676Class IIApexElekta Limited / cleared 2011-09-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)