Oncentra Brachy users using version 4.0 and above with… recallZ-0182-2022 · Elekta, Inc. · initiated Oct 13, 2021

Why it was recalled

Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.

FDA root cause category: Software design

What the company is doing

An Urgent Important Field Safety Notification letter (FAC-NU-0007) was issued to consignees to notify of the issue, clinical impact and recommend the following: 1) Recommended User Action in the unique scenario, which is only applicable for the Venezia" applicator: Avoid use of the combination of the two Venezia" applicator Anchor Points O1-Center and O2-Center by disabling one of them in the Applicator Library Manager. 2)Recommended User Action in the exceptional situation that may also occur for other Applicator Models: Avoid incorrect placement of the Anchor Points, especially exchanging left / right anchor point positions. 3) Recommended User Actions for both scenarios: Until an updated version of Oncentra Brachy is available, it is strongly advised: " To use additional Anchor Points during applicator modelling. This will further reduce the chance of mirroring the Applicator Model. " To cross-check the source dwell position information from the Case Explorer to be in accordance with the source dwell positions in the image views. " Use the Triangles option for the applicator skin visualization in the 3D view, and review whether the Applicator Model has a correct shading display. " Perform proper Quality Assurance for all treatment plans before treatment delivery. Consignees are required to acknowledge receipt of the notification to Elekta within 30 days.

Recall details

Recall number

Z-0182-2022

Status

Open, Classified

Initiated by the company

Oct 13, 2021

Recalling firm

Elekta, Inc.

Quantity

1072 devices

Product code

MUJ

FDA submissions

K132816

Distribution

Distribution throughout USA OUS distribution including:Algeria, Argentina, Australia, Austria Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Botswana, Brazil Brunei, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam

Product description

Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

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