Z-0987-2017Class II

Oncentra External Beam Oncentra Brachy

Name: Z-0987-2017 Oncentra External Beam Oncentra Brachy
Creator: Elekta, Inc.
Published: 2016-12-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-12-23 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three... on 2016-12-23. FDA classified it as Class II and gives the reason as "Cross profile for Varian 60 degree wedge shows "horns."". 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-0987-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Posted: 2017-01-10
Terminated: 2021-07-16
Recalling firm: Elekta Limited
Product: Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Cross profile for Varian 60 degree wedge shows "horns."
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Urgent Important Safety Notification letter dated December 23, 2016 to affected customers. The notice informs users of the specific product and version numbers affected by the issue and any work arounds that can be used to avoid the issue. The letter included an acknowledgement form to be returned to Elekta.
Quantity in commerce: 433
Distribution: Worldwide Distribution - US Nationwide in the states of AL, CA, DC, NE, NY, ND, OR, PA, RI, SC, TX, and the countries of Angola, Argentina, Armenia, Australia, Austria, Barbados, Belarus, Brazil, Bulgaria, Canada, China Columbia, Curacao, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Kazakhstan, Kenya, Malaysia, Netherlands, Norway, Oman, Peru, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Yemen, Zambia.
Product codes and lots: All software builds

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0987-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0987-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

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)