Medical device manufacturer, Philips Healthcare, has issued a field safety notice (FSN) concerning its Pinnacle3 Radiation Treatment Planning System with software version 9 0, 9 2 9 4, and 9 6.
The issue occurs under certain specific conditions where the user modifies a contour in a density-overridden ROI (region of interest with density set to a specific value) in a computed plan. Dose is subsequently invalidated and the user may recompute the dose. In this case, the density can be replaced by the CT number from the CT to density table when recomputed resulting in an incorrect dose and the Monitor Units (MU) may then be much higher than originally planned. The user may continue, and save the plan with incorrect dose. When reopening the plan, the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.
This issue could create an incorrect MU calculation, resulting in an incorrect dose to the target or other structures. If the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose.¬
The manufacturer will upgrade all the affected units to version 9.8 and it recommends users to always use version 9.8 or above for patient planning. If users do not have version 9.8 installed, they should contact local representative. Furthermore, the FSN should be placed in Instructions for Use until otherwise notified.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 8 Aug 2014