| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01010-1 |
| Product Name/Description |
VariSource iX Control Software
Affected Versions/Lots: Version 1.2.1, Build 3726 and Version 1.2, Build 2.4336
ARTG Number: 119982 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
An anomaly has been identified with the VariSource iX Control Software. In the event a forced logoff occurs while the dummy wire is extended during a treatment session, the Partial Fraction generated by the system will be incorrect.
The control software does not differentiate the re-start dummy sweep from the dummy sweep at the beginning of the treatment session. The control software assumes no treatment has been delivered. The Partial Fraction generated will be equivalent to the original full fraction.
If this Partial Fraction is treated, this would result in re-treatment of any dwell positions actually delivered prior to the session interrupt and result in a dose greater than intended. The Treatment Recovery Report will incorrectly indicate that no dwell positions have been treated. Both the Treatment Delivery Report and the Treatment History Report do correctly indicate the dwell positions treated.
There have been no reports of patient injury due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Varian Medical Systems is developing a technical correction for this issue. A Technical Service representative will contact the affected hospital when this correction is available to schedule its installation. In the interim a workaround is provided in the Customer Letter.
This action has been closed out on the 12/10/2018. |
| Contact Information |
02 9485 0133 - Varian Customer Service |