| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00947-1 |
| Product Name/Description |
4D Integrated Treatment Console (4DITC) Version: 10 and 11 (Used for accurate treatment delivery by monitoring linear accelerator parameters)
Product code: H51
Serial Numbers: H514278, H514544, H515102, H51B568, H513894, H515619 & H51B100
ARTG Number: 116839 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Varian received two reports from customers with C-Series linear accelerators (linac) used with Varian’s Barcode Conical Collimator Verification system (BCCV) and BrainLab’s ExacTrac patient positioning system where the user was able to clear the interlock for BCCV, imposed by the 4DITC, from the ExacTrac console.
In both reported cases, the user was employing a C-Series HE linac with 4DITC and both ExacTrac and BCCV. The user was authorising the ExacTrac to the linac 4DITC. Successive signals were sent from the ExacTrac to the 4DITC. The first signal cleared the ExacTrac interlock as intended. The ExacTrac console requested user confirmation of the second command to authorise. The user responded affirmatively. The signal was sent to the 4DITC, and the linac interlock associated with BCCV was released. In such a situation, it may be possible to irradiate the patient using a cone other than what is specified by the treatment plan because the BCCV verification was not completed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian is reminding users of the correct procedures using auxiliary devices requiring the ADI interface and is providing recommended verification steps when carrying out treatment i.e., stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). A permanent fix has been developed and a Varian representative will schedule the installation. This action has been closed-out on 12/08/2016. |
| Contact Information |
02 9485 0100 - Varian Regulatory Affairs |