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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00439-1
Product Name/Description ExacTrac 5.5.5 (Image guided radiation therapy patient positioning system)

Product Version Number: ExacTrac 5.5.5

ARTG Number: 121226
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 14/04/2014
Responsible Entity Brainlab Australia Pty Ltd
Reason/Issue When using a specific plan update workflow in combination with a non-Brainlab treatment planning system (TPS), there is a possibility in ExacTrac 5.5.5 to generate an unintended blend of two initially separate plans of the same patient. If the anomaly occurs, the information displayed by ExacTrac under “External Name” and “Dicom Patient Coordinates” might not be correctly related to the information simultaneously displayed within the “Image Set Reconstruction” picture and under “BrainLAB Coordinates”. Such a display of inconsistent positioning information might mislead the user when selecting a treatment plan / isocenter in ExacTrac for patient positioning. If not detected by the user, this might result in a patient and treatment target position at the linear accelerator (linac) that is different than intended. As a consequence the treatment dose might be delivered to a region different from the intended target region.
Recall Action Recall for Product Correction
Recall Action Instructions Customers are advised to continue to always follow the instructions and warnings as described in the user guide. Brainlab also recommends:
- To enter meaningful plan comments during treatment planning. When selecting a plan in ExacTrac, before proceeding with patient positioning, always review this comment within ExacTrac together with the plan date.
- To always verify the correct isocenter position inside the “Image Set Reconstruction” picture before proceeding with patient positioning.

Brainlab will provide a software update to the affected customers which will resolve the issues identified.
Contact Information 02 9424 3800 - Brainlab Australia Pty Ltd