| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01084-1 |
| Product Name/Description |
ARIA Oncology Information System, version 11 (A suite of software modules designed to manage the entire process of a patient's course of treatment including treatment plans and image management)
Product code: HIT
Affected serial numbers: HIT0339M and HIT0339R1
ARTG Number: 132638 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
An anomaly has been identified with the ARIA Oncology Information System Version 11 where monitor units of one fraction may be incorrect, when partial treatment is being continued. The issue happens when a treatment is interrupted mid-field (for example, by a power loss) and the delivered monitor units for the partially treated field are entered manually in the treatment record. When the partial treatment is resumed, the system will not use the full remaining planned monitor units for the affected field, thus leaving the fraction under dosed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian is recommending users to implement work around instructions until a software fix is developed and implemented. |
| Contact Information |
1800 657 036 - Varian Oncology Helpdesk |