Medical device manufacturer, Varian Medical Systems, has issued an urgent field safety notice concerning 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1.
4D ITC is designed to assist in providing radiation treatment for patients. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information. The majority of the issues experienced fall into one of three general categories:
According to the manufacturer, the root cause is related to software design deficiency. Varian has scheduled for a mandatory upgrade of the 4DITC to version 10.2 in order to address the above issues.
Varian also supplemented that the device has been distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.