Elekta, Inc. Oncentra Brachy radiation therapy planning system software. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Oncentra Brachy radiation therapy planning system software.
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Elekta, Inc. is recalling Oncentra Brachy radiation therapy planning system software. due to A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026