Z-0604-2016Class II

Oncentra External Beam - VMAT - Radiation therapy planning system

Name: Z-0604-2016 Oncentra External Beam - VMAT - Radiation therapy planning system
Creator: Elekta, Inc.
Published: 2015-12-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-12-18 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to... on 2015-12-18. FDA classified it as Class II and gives the reason as "When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas...". 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-0604-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Posted: 2016-01-07
Terminated: 2021-09-15
Recalling firm: Elekta Limited
Product: Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When using the option "Tumor Overlap Fraction" in VMAT planning it has been observed that in rare cases the system does include an organ at risk as target volume. This could result in open MLC, and open jaws in areas away from the target volume.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Field Safety Notice 806-01-ETP-001 to all affected customers on December 18, 2015. The notice informs users of the issue and that should the issue occur it could result in overdosage of organs at risk outside the intended treatment volume. Users are strongly advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient. To prevent the issue from occurring, the workaround is to not use the Tumor Overlap Fraction for VMAT planning.and not to use the Tumor Overlap Fraction for VMAT planning. The issue will be solved in Oncentra External Beam version 4.5.2. The notice included an acknowledgement form which is to be returned to Elekta. For questions contact your local Elekta representative.
Quantity in commerce: 154
Distribution: Worldwide Distribution - US Nationwide in the states of CA, NY, PA, and the countries of Austria, Belarus, Canada, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Netherlands, Norway, Poland, South Korea, Spain, Sweden and United Kingdom.
Product codes and lots: Versions 3.3 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0604-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0604-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-06

Product code MUJ

K121448Class IIOncentra, Oncentra External Beam, Oncentra BrachyElekta Inc. D/B/A Nucletron Corporation / cleared 2012-07-02

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)