Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 16913 |
| Brand Name: | Varian C-Series High Energy Linear Accelerator |
| Model: | Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300 C/D, Clinac DHX, Clinac 21EX, Clinac 23EX |
| Affected: | |
| Software version: | Version: 7, 8 and 9 with 6 MV configuration and maximum dose rate of at least 600 MU/min ONLY |
| Recalling Organisation: | Varian Medical Systems Australasia Pty Ltd (NZ) Millenium Centre, Level 3, Building C, 600 Great South Road Ellerslie Auckland 1051 |
| Contact Information: | 0800 486 732 |
| Manufacturer: | Varian Medical Systems Inc |
| Issue: | Varian has received several reports of unexpected beam output variations with the C-Series High Energy [HE] Linear Accelerator for 6MV photon treatment mode. The Issue has been reported for versions 7, 8 and 9 with 6 MV configuration and maximum dose rate of at least 600 MU/min ONLY. It was determined during intensive investigation that the 6MV target had developed a cavity or hole. Degradation of the target led to beam output and symmetry changes which were not detected by the linear accelerator. The result is that a lower than intended dose could be delivered to the target volume if treatment were to take place. Varian has not received any report of misadministration or injury due to this 6MV target degradation or failure. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/7/2014 |
