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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01069-1
Product Name/Description Oncentra Brachy using versions 4.5, 4.5.1 and 4.5.2

Reference Number: FCA-NU-0004

ARTG Number: 142110
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 16/08/2017
Responsible Entity Nucletron Pty Limited
Reason/Issue Elekta has identified an issue with Oncentra Brachy with the default step size set in RDStore.
The measured source paths for a ring-type applicator have a source step size of 2.5mm for the microSelectron afterloader. When creating a plan for a Ring applicator with a measured source path, the step size will be used for the entire plan.
If such an applicator model is used while the default step size of the afterloader is 5.0, the step size in the ring or lunar-shaped ovoids will be incorrect. They will be shown as 2.5mm, while the afterloader will deliver at 5.0mm if the error is not detected during plan approval.
If this plan is exported to the microSelectron Treatment Control System (TCS) and delivered, the treated dwell positions in the ring will be incorrect. When loading the plan in TCS only the dwell position numbers and source step size are taken over from the Oncentra Brachy plan. This leads to a shift of the treated dwell positions in the ring due to the incorrect step size.
Recall Action Recall for Product Correction
Recall Action Instructions Until an upgraded version of Oncentra Brachy is available, users are strongly recommended to use a default source step size of 2.5mm for microSelectron afterloaders in RDStore.
If a larger default source step size is required in RDStore, a workaround is to reselect the same after loader in the Prescription dialog in the Oncentra Brachy planning module. The source step size is then forced to the correct value of 2.5mm.
Users are advised to perform proper Quality Assurance for all treatment plans before delivery of the first fraction to the patient.
The issue will be solved in the next version of Oncentra Brachy.
This action was closed out on 14/09/2018
Contact Information 02 8907 1800 - Elekta Care Support Centre