| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00314-1 |
| Product Name/Description |
ExacTrac (Image guided radiation treatment therapy patient positioning system)
Version numbers 5.0, 5.0.1, 5.0.2 and 5.5, 5.5.1, 5.5.2
ARTG Number: 121226 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/04/2013 |
| Responsible Entity |
|
| 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.x 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 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 |
Brainlab is providing users with work around instructions and is implementing a permanent software fix to correct the problem. |
| Contact Information |
02 9424 3800 - Brainlab Australia |