| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00137-1 |
| Product Name/Description |
ExacTrac Patient Positioning System with software versions 6.0, 6.1, 6.2, 6.5
ARTG Number: 121226 (Brainlab Australia Pty Ltd - ExacTrac / Novalis Body - Patient positioning device, diagnostic imaging/radiotherapy, whole body) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
When using ExacTrac on a Varian Clinac or Varian TrueBeam system equipped with the ADI, beam requests of the treatment application have to be authorized by ExacTrac to enable treatment. As per the IFU, if no patient data is loaded in ExacTrac, ExacTrac always authorizes every beam request from the Varian side. This is required and intended for clinical treatments where ExacTrac is not used for patient positioning.
Brainlab is clarifiying that the beam authorization by ExacTrac via ADI is not a safety feature to ensure correct patient positioning before treatment.
For any treatments performed with ExacTrac always verify that ExacTrac confirms the target position by displaying the OK icon.
If a deviation of the patient position from the planned treatment position remains undetected by the user and the actual treatment beam that has been previously authorized by ExacTrac via ADI is initialized, underdose of the planned target and/or overdose of healthy tissue could occur. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Brainlab is advising users to always follow the IFU during use and to verify that ExacTrac confirms the target position by displaying the OK icon.
Brainlab is providing updated Instructions for use.
For treatments that have already been performed, the actual patient position during treatment can be reviewed in the treatment report of ExacTrac, and by using the Review function in the ExacTrac software.
This action has been closed out on 07/11/2018 |
| Contact Information |
02 9424 3800 - Customer Service Support |