Elekta, Inc. Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
Brand
Elekta, Inc.
Lot Codes / Batch Numbers
08717213038660, 08717213020610, 08717213052321, 08717213052314, 08717213052307, 08717213052291, 08717213052246, 08717213052239, 08717213051881, 08717213051843, 08717213051782, 08717213051775, 08717213051294, 08717213020610, 08717213053717, 08717213053700
Products Sold
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
Elekta, Inc. is recalling Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 due to Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA
Page updated: Jan 10, 2026