Oncentra Brachy radiation therapy planning system software recallZ-0719-2023 · Elekta, Inc. · initiated Dec 5, 2022

Why it was recalled

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number

Z-0719-2023

Status

Open, Classified

Initiated by the company

Dec 5, 2022

Posted by the FDA

Dec 15, 2022

Recalling firm

Elekta, Inc.

Quantity

336 systems

Product code

MUJ

FDA submissions

K132816

Distribution

Distribution US nationwide, including Puerto Rico. There was no military/government distribution.

Product description

Oncentra Brachy radiation therapy planning system software.

Devices named in this recall

16 devices in the FDA device registry whose identifier appears in the recall's code information.

• NA 170003-28

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls2 reports
• NA 170607-00

  Nucletron B.V. · System, planning, radiation therapy treatment
  2 recalls1 report
• NA 170730

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA Oncentra Brachy

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170730

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170003-23

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170537-04

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170003-24

  Nucletron B.V. · System, applicator, radionuclide, remote-controlled
  2 recalls0 reports
• NA 170537-05

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170003-25

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170537-06

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170003-27

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170537-06

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170537-08

  Nucletron B.V. · System,planning,radiation therapy treatment
  2 recalls0 reports
• NA 170018-00

  Nucletron B.V. · System, planning, radiation therapy treatment
  2 recalls0 reports
• NA 170538-00

  Nucletron B.V. · System, planning, radiation therapy treatment
  2 recalls0 reports