Elekta, Inc.: Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00

Recall number

Z-0182-2022

Recalling firm

Elekta, Inc.

Product

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

Status

Open, Classified

Initiated

2021-10-13

Posted

not on file

Terminated

not on file

Reason

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

Root cause

Software design

Action

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.

Quantity

1072 devices

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

Lot, serial or model codes

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

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

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