CLASS II Device recall · Reported 1 Nov 2017 · FDA Enforcement Report

Oncentra Brachy 5 radiation therapy recalled by Nucletron BV

Nucletron BV is recalling Oncentra Brachy 5 radiation therapy, distributed nationwide in the US. The recall was initiated on 10 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions 4.5, 4.5.1, and 4.5.2.

Quantity recalled89 customer sites have the affected software

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-0050-2018
FDA event ID: 78087
Recalling firm: Nucletron BV, Veenendaal, N/A
Classification: Class II
Status: Terminated
Recall initiated: 10 Aug 2017
FDA classified: 26 Oct 2017
Reported: 1 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

10 Aug 2017	Recall initiated by company
26 Oct 2017	Classified by FDA	+77 days
1 Nov 2017	Published in enforcement report	+6 days

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

Reason for recall

Incorrect source step size may occur in the software plans

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 Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment and may be used to administer treatments after review and approval by qualified medical personnel.

Where it was distributed

Worldwide Distribution - USA (nationwide) to medical facilities, and to the countries of : Canada, Argentina, Australia, Austria Bangladesh, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, United Arab Emirates, and Viet Nam. There was no military/government distribution.

Nationwide

Questions about this recall

Is Oncentra Brachy 5 radiation therapy recalled?

Yes. Nucletron BV recalled Oncentra Brachy 5 radiation therapy on 10 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0050-2018.

Why was it recalled?

Incorrect source step size may occur in the software plans

Which lots are affected?

Versions 4.5, 4.5.1, and 4.5.2.

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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