Z-1712-2015Class II

Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in...

Name: Z-1712-2015 Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in...
Creator: Elekta, Inc.
Published: 2015-05-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-05-21 / Terminated

FDA source

Elekta, Inc. began a recall of Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients... on 2015-05-21. FDA classified it as Class II and gives the reason as "Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1712-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-21
Posted: 2015-06-04
Terminated: 2021-07-16
Recalling firm: Elekta Limited
Product: Oncentra Brachy radiation therapy 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: Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.
FDA root cause: Other
Action: Important User Notice, 806-03-BTP-001, was distributed to customers on 5/21/2015, A software patch is in development and is expected to be released end of November, 2015. Elekta service will work with customers to implement the patch on affected devices within 6 months of the patch release.
Quantity in commerce: 351
Distribution: AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NC, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WV, WI, Argentina, Australia, Bangladesh, Belarus, Botswana, Brazil, Canada, Chile, China, Colombia, Ecuador, Egypt, Guatemala, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kosovo, Libya, Malaysia, Mexico, Morocco, Namibia, Nepal, New Zealand, Oman, Pakistan, Peru, Philippines, Qatar, Russia, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Suriname, Taiwan, Thailand, Tobago, Ukraine, Venezuela, Vietnam, Zambia
Product codes and lots: MUJ/892.5050, Software Builds - 3.3, 4.0, 4.1, 4.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1712-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1712-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-04

Product code MUJ

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)