Z-0719-2023Class II

Oncentra Brachy radiation therapy planning system software

Name: Z-0719-2023 Oncentra Brachy radiation therapy planning system software
Creator: Elekta, Inc.
Published: 2022-12-05
License: https://open.fda.gov/license/

Elekta Limited / initiated 2022-12-05 / Open, Classified / root cause: software

FDA source

Elekta, Inc. began a recall of Oncentra Brachy radiation therapy planning system software on 2022-12-05. FDA classified it as Class II and gives the reason as "A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0719-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-05
Posted: 2022-12-15
Recalling firm: Elekta Limited
Product: Oncentra Brachy radiation therapy planning system software.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Root cause tag: software
FDA root cause: Software design
Action: Elekta issued an Important Field Safety Notice 806-01-BTP-003 dated November 2022 to all affected customers on 12/5/2022 via email. 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 notice is to be posted in a place accessible to all users until this action is closed. Appropriate personnel working with the product are to be advised of the content of the letter. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta representative as soon as possible but no longer than 30 days from receipt. Update: The manufacturer has now released the solution to this issue for affected Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00. All affected customers will receive a software update in order to solve the issue. The solution was released for installation in the field on 20-MAR-23. Customers are being notified by email on 03/20/2023. Customers are being informed that the fix is available for download/request depending on their standard processes. Elekta service teams will pro-actively follow up with customers to insure the fix has been installed before the target completion date.
Quantity in commerce: 336 systems
Distribution: Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
Product codes and lots: Version 4.0 and above with Applicator Modeling or Implant Modeling; UDI GTIN numbers: 08717213052758, 08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0719-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0719-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-21	2022-12-15

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)