FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Oncentra Brachy radiation therapy planning system software.
- Recall number
- Z-0719-2023
- Recalling firm
- Elekta, Inc.
- Product
- Oncentra Brachy radiation therapy planning system software.
- Status
- Open, Classified
- Initiated
- 2022-12-05
- Posted
- 2022-12-15
- Terminated
- not on file
- Reason
- A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
- 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
- 336 systems
- Distribution
- Distribution US nationwide, including Puerto Rico. There was no military/government distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K132816"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 1037831
- Firm city
- Atlanta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28