| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01235-1 |
| Product Name/Description |
ARIA Radiation Oncology System (information system), versions: 11.0 below 11.0.55, Build 11.02.28 and 11.0.34
Product code: HIT
Affected ARIA versions: 11.0 below 11.0.55, Build 11.02.28 and 11.0.34
Affected serial numbers: HIT0339M, HIT0339R1 & HIT4909
ARTG number: 132638 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
An anomaly has been identified during internal investigation with the ARIA Oncology Information System version 11 DICOM Import/Export functionality where a 360 degree arc field may convert to static field during DICOM export or import. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian is providing work around instructions to users and is developing a permanent solution. |
| Contact Information |
1800 657 036 - Varian Oncology Helpdesk |