Z-0050-2018Class II

Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a...

Name: Z-0050-2018 Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a...
Creator: Nucletron BV
Published: 2017-08-10
License: https://open.fda.gov/license/

Nucletron BV / initiated 2017-08-10 / Terminated / root cause: software

FDA source

Nucletron BV began a recall of 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... on 2017-08-10. FDA classified it as Class II and gives the reason as "Incorrect source step size may occur in the software plans". 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-0050-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-10
Posted: 2017-10-26
Terminated: 2020-11-20
Recalling firm: Nucletron BV
Product: 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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Incorrect source step size may occur in the software plans
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Field Safety Notice notification dated August 2017, and was emailed to customers on August 10, 2017, informed users of the issue and workarounds that can be used to avoid the issue.The user is informed the issue will be resolved in a fix which will be released by the end of February 2018. Once released, the firm will proactively reach out to all affected customers to arrange a time to install the fix. An acknowledgement form was enclosed which the user was to complete to indicate they have read and understood the notice and accept implementation of any given recommendations. For further questions, please call (770) 670-2359.
Quantity in commerce: 89 customer sites have the affected software
Distribution: 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.
Product codes and lots: Versions 4.5, 4.5.1, and 4.5.2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0050-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0050-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-01	2017-10-26

Product code MUJ

K132816Class IIOncentra BrachyNucletron B.V. / cleared 2014-06-13

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)