Z-0118-2013Class II

Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation...

Name: Z-0118-2013 Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation...
Creator: Elekta, Inc.
Published: 2012-08-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-08-21 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of... on 2012-08-21. FDA classified it as Class II and gives the reason as "During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan...". 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-0118-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-21
Posted: 2012-10-23
Terminated: 2014-11-03
Recalling firm: Elekta Limited
Product: Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages.
Root cause tag: software
FDA root cause: Software design
Action: Nucletron sent a Customer Information Bulletin 555.00248 to all affected customers. The bulletin identified the product, problem, and actions to be taken by the customers. The bulletin contained information on how an incorrect dose association can be prevented by not renumbering beams during recalculation. A Read Confirmation Form was included for customers to complete and return. Contact your local Nucleton Service Representative for questions regarding this notice.
Quantity in commerce: 52 units
Distribution: Nationwide Distribution-including the states of AL, CA, DC, KS, LA, MO, NB, NY, NC, ND, OH, OR, PA, RI, SC, TX, and WA.
Product codes and lots: None as the product is software

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0118-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0118-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-23

Product code MUJ

K081281Class IIOcentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation / cleared 2008-05-20

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)