Oncentra Brachy radiation therapy planning software… recallZ-1712-2015 · Elekta, Inc. · initiated May 21, 2015

Why it was recalled

Incorrect dose calculation for Regions of Interest (ROIs) defined on a secondary image series.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number

Z-1712-2015

Recall class

Class II

Status

Terminated

Initiated by the company

May 21, 2015

Posted by the FDA

Jun 4, 2015

Recalling firm

Elekta, Inc.

Quantity

351

Product code

MUJ

FDA submissions

K081281, K121448

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 description

Oncentra Brachy radiation therapy planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

Other devices under the same FDA submission

15 devices cleared under K081281, K121448 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• 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 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