| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00182-1 |
| Product Name/Description |
RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system)
Software build number : 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13 or 4.7.4.4
ARTG Number: 195288 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
A software bug has been reported that when using certain ROI (region of interest) editing tools, if simultaneously right clicking, pressing Ctrl-S or Ctrl-Z while the left mouse button is held down, the views can appear as if the left mouse button had been released to complete editing. In order for the bug to cause saving of an unintended state, it has to be triggered during the very last edit made to the ROI. Saving of an unintended state may lead to ineffective and/or unintended radiation therapy.
The patient views and the beam’s eye view will always be displayed correctly in the Plan approval dialog and in the plan reports. Closing and reloading a case will always generate correct views. Dose is always computed based on the stored system state. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
This issue will be resolve after the installation of RayStation 5 Service Pack 1, which was released Q1 2016. In the interim, users are advised to:
-Always release the left mouse button before using other keys or mouse buttons.
-If the warning message “Temporary items should not be visible on approval” is displayed or if there is some suspicion that the bug may have been triggered in structure definition, either review the structures in the Plan approval dialog, or close and reload the patient case and review the structures again. This action has been closed-out on 06/02/2017. |
| Contact Information |
(02) 9006 1662 - Emergo Australia |