| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00975-1 |
| Product Name/Description |
Pinnacle3, software versions 9.0, 9.2. 9.4, 9.6 (Radiation Treatment Planning System)
ARTG Number: 118156 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
9/09/2014 |
| Responsible Entity |
|
| Reason/Issue |
The issue occurs under certain specific conditions where the user modifies a contour in a density-overridden ROl (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 the plan is reopened, the density is reported as the correct value but the dose remains incorrect based on the prior incorrect value for density.
An incorrect radiation dose to the target or other structures could occur. If the situation is noticed prior to completion of the treatment, the incorrect beam could be corrected to give the correct total dose. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Version 9.8 corrects the issue. Philips recommends that user always use version 9.8 or above for patient planning. Philips will provide version 9.8 to those customers that still have version 9.0, 9.2, 9.4 or 9.6. This action has been closed-out on 17/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |