CLASS II Device recall · Reported 13 Jan 2016 · FDA Enforcement Report

Oncentra External Beam - VMAT - Radiation therapy planning system recalled

Elekta is recalling Oncentra External Beam - VMAT - Radiation therapy planning system, distributed nationwide in the US. The recall was initiated on 18 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions 3.3 and higher

Quantity recalled154

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0604-2016
FDA event ID: 72869
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2015
FDA classified: 6 Jan 2016
Reported: 13 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

18 Dec 2015	Recall initiated by company
6 Jan 2016	Classified by FDA	+19 days
13 Jan 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California New York Pennsylvania

Stores named: Target

Questions about this recall

Is Oncentra External Beam - VMAT - Radiation therapy planning system recalled?

Yes. Elekta recalled Oncentra External Beam - VMAT - Radiation therapy planning system on 18 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-0604-2016.

Why was it recalled?

Which lots are affected?

Versions 3.3 and higher

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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