| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00920-1 |
| Product Name/Description |
Eclipse Treatment Planning System, (radiation therapy treatment planning system). Versions: 8.9 and 10
Product Code: H48
Multiple serial numbers affected
ARTG Number: 119983 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
When the clock on the Eclipse client workstation is running behind the clock on the Database/System server, it is possible that a change to the assigned HU value for a structure dose not invalidate the density image stored in the cache, and for the subsequent dose and Monitor Unit calculation to be based on the outdated HU assignment. The resultants MUs may be higher or lower than expected. treatment of the patient using these values can lead to under or overdosing. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian is providing users with work around instructions and will be providing a technical correction to permanently correct the issue when available. |
| Contact Information |
1800 657 036 - Varian Oncology Helpdesk |