| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01133-1 |
| Product Name/Description |
Clinac, Trilogy, Trilogy Tx, Novalis Tx and Unique accelerators, software versions 7.x, 8.x and 9.0. (Linear accelerator system)
Product Codes: H14, H18, H27 and H29
ARTG Number: 116839
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has received reports in which a user has remotely rotated the gantry into contact with the couch or with patients, in both the manual mode and the automated mode. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian is reminding users to ensure patients are observed during manual and automatic gantry movements. Varian is providing a software update to permanently correct the issue. This action has been closed-out on 01/02/2016. |
| Contact Information |
1800 657 036 - Varian Helpdesk |