ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
Recall
- Recall Number
- Z-1006-2018
- Event Number
- 79266
- Firm
- Brainlab AG Olof-Palme-Strasse 9 Munich Germany
- FEI Number
- 3002619595
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 14, 2018
- Terminated
- May 17, 2021
Description
ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.
The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI.
The firm disseminated their notices by email on 02/14/2018. The notice requests the following actions: "User Corrective Action: Always follow the instructions below during use of ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam: Do not use beam authorization by ExacTrac via ADI as 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. Do not treat the patient if the OK icon is not displayed. This indicates that the isocenter is in the planned treatment position. The treatment beam should not be activated unless the OK icon is shown. If using ExacTrac on a Varian Clinac or Varian TrueBeam system equipped with the Auxiliary Device Interface (ADI) always perform treatment in the following sequence: 1. Start the ExacTrac Software and login using your user name and password 2. Load the Plan / Patient on the Varian Treatment Application / Console 3. Open the Plan / Patient on ExacTrac by clicking Open in the message box (refer to Figure 2) 4. Prepare the beam on the Varian Treatment Application / Console If you intend to perform treatments for which ExacTrac is not used for patient positioning, please click Cancel in the message box to confirm not opening the patient and to continue the treatment without ExacTrac. ExacTrac can be configured to directly load the patient automatically in ExacTrac if it is opened on the Varian Treatment Application / Console - meaning that the message box (refer to Figure 2) is deactivated. However, this may not be the preferred solution for each user, as automatic loading causes delays in treatment preparation if no positioning via ExacTrac is to be used, since in these cases the patient data has to be closed manually. Please contact your local Brainlab Customer Support Representat
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